Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study

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Methods In a prospective two-center study at Al-Thawra Modern General Hospital and Kuwait University Hospital, Sana’a, Yemen, from January 2018 to September 2024, 65 patients (≥18 years) with closed, displaced midshaft clavicular fractures (displacement >2 cm, shortening >2 cm, comminution, or skin tenting) underwent ORIF. Functional outcomes were evaluated six months postoperatively using the University of California, Los Angeles (UCLA) shoulder rating score. Data were analyzed using SPSS version 26. Results The mean patient age was 32.09 years (83.1% male, n=54). Road traffic accidents were the primary mechanism of injury (66.2%, n=43). At 6 months, the mean UCLA score was 32.46 ± 2.54, with 98.5% (n=64) achieving good or excellent outcomes (UCLA score ≥27) and 1.5% (n=1) fair/poor. Complications included hardware irritation (1.5%, n=1), hardware failure (3.1%, n=2), and superficial infections (1.5%, n=1). All patients (100%) reported satisfaction with their outcomes. The UCLA scores varied significantly according to injury mechanism, side, and age, with older patients showing lower scores. Conclusion ORIF with precontoured locked plates yielded promising functional outcomes, high patient satisfaction, and low complication rates. However, the observational design, lack of a control group, and 6-month follow-up limit broader conclusions. Larger controlled studies are needed to validate these findings and guide the optimal management of displaced midshaft clavicular fractures. 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F1000Research 2025, 14 :374 ( https://doi.org/10.12688/f1000research.162891.3 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Research Article Revised Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] Abdullah Ali Al-Moaish 1,2 , Jamal Abdulraheem Algabarty 1 , Anwar Mughallas 1,2 , [...] Ali Mustafa Alhamzi https://orcid.org/0009-0006-4827-706X 2,3 , Mosleh Soliaman 3 , Mohammed Hutaif 1,2 , Mohammed Abdulmoghni 1,2 , Abdukareem Hussain Almahdi 1,2 , Haitham Mohammed Jowah https://orcid.org/0009-0008-3815-3017 2 Abdullah Ali Al-Moaish 1,2 , Jamal Abdulraheem Algabarty 1 , [...] Anwar Mughallas 1,2 , Ali Mustafa Alhamzi https://orcid.org/0009-0006-4827-706X 2,3 , Mosleh Soliaman 3 , Mohammed Hutaif 1,2 , Mohammed Abdulmoghni 1,2 , Abdukareem Hussain Almahdi 1,2 , Haitham Mohammed Jowah https://orcid.org/0009-0008-3815-3017 2 PUBLISHED 28 Aug 2025 Author details Author details 1 Department of Orthopedic Surgery, Al-Thawra Modern General Hospital, Sana'a, Yemen 2 Department of Surgery, Sana'a University, Sana'a, Yemen 3 Department of Orthopedic Surgery, Kuwait University Hospital, Sana'a, Yemen Abdullah Ali Al-Moaish Roles: Conceptualization, Investigation, Methodology, Project Administration, Resources, Writing – Original Draft Preparation Jamal Abdulraheem Algabarty Roles: Conceptualization, Data Curation, Methodology, Supervision, Validation, Writing – Review & Editing Anwar Mughallas Roles: Data Curation, Investigation, Writing – Review & Editing Ali Mustafa Alhamzi Roles: Data Curation, Investigation, Methodology Mosleh Soliaman Roles: Investigation, Methodology, Resources Mohammed Hutaif Roles: Data Curation, Methodology, Writing – Review & Editing Mohammed Abdulmoghni Roles: Data Curation, Methodology, Writing – Review & Editing Abdukareem Hussain Almahdi Roles: Data Curation, Investigation, Methodology Haitham Mohammed Jowah Roles: Formal Analysis, Software, Validation, Visualization, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS Abstract Abstract Background This study assessed the functional outcomes and complications of open reduction and internal fixation (ORIF) using precontoured superior clavicle locking plates for displaced midshaft clavicular fractures. Methods In a prospective two-center study at Al-Thawra Modern General Hospital and Kuwait University Hospital, Sana’a, Yemen, from January 2018 to September 2024, 65 patients (≥18 years) with closed, displaced midshaft clavicular fractures (displacement >2 cm, shortening >2 cm, comminution, or skin tenting) underwent ORIF. Functional outcomes were evaluated six months postoperatively using the University of California, Los Angeles (UCLA) shoulder rating score. Data were analyzed using SPSS version 26. Results The mean patient age was 32.09 years (83.1% male, n=54). Road traffic accidents were the primary mechanism of injury (66.2%, n=43). At 6 months, the mean UCLA score was 32.46 ± 2.54, with 98.5% (n=64) achieving good or excellent outcomes (UCLA score ≥27) and 1.5% (n=1) fair/poor. Complications included hardware irritation (1.5%, n=1), hardware failure (3.1%, n=2), and superficial infections (1.5%, n=1). All patients (100%) reported satisfaction with their outcomes. The UCLA scores varied significantly according to injury mechanism, side, and age, with older patients showing lower scores. Conclusion ORIF with precontoured locked plates yielded promising functional outcomes, high patient satisfaction, and low complication rates. However, the observational design, lack of a control group, and 6-month follow-up limit broader conclusions. Larger controlled studies are needed to validate these findings and guide the optimal management of displaced midshaft clavicular fractures. READ ALL READ LESS Keywords clavicle fracture, precontoured locked plate, functional outcomes, surgical management, complications, patient satisfaction, midshaft fracture, ORIF Corresponding Author(s) Haitham Mohammed Jowah ( [email protected] ) Close Corresponding author: Haitham Mohammed Jowah Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2025 Al-Moaish AA et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Al-Moaish AA, Algabarty JA, Mughallas A et al. Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.12688/f1000research.162891.3 ) First published: 01 Apr 2025, 14 :374 ( https://doi.org/10.12688/f1000research.162891.1 ) Latest published: 28 Aug 2025, 14 :374 ( https://doi.org/10.12688/f1000research.162891.3 ) Revised Amendments from Version 2 This revised version of the article incorporates significant enhancements based on feedback from peer review, aimed at improving methodological rigor, transparency, and contextual depth. The Introduction has been substantially rewritten to provide a more comprehensive and updated literature review on midshaft clavicular fractures, including numerous recent references (2020-2025) and a more balanced discussion of treatment outcomes. Methodological reporting has been significantly strengthened throughout. The study design is now explicitly defined as a prospective observational cohort study conducted in accordance with STROBE guidelines. A new STROBE-compliant patient enrollment flowchart (Figure 1) has been added to the Results section to clearly illustrate patient selection. Vague language regarding the study protocol has been replaced with specific details, including a new structured three-phase rehabilitation protocol and clearer descriptions of the outcome measures used. The presentation of data and statistical analysis has also been improved. Patient Body Mass Index (BMI) data has been included in the demographic characteristics (Table 1). The Statistical Analysis section now provides a more explicit description of the correlational tests performed, and the Limitations section transparently addresses the rationale for the statistical methods chosen, including why a multivariate analysis was not feasible. Finally, the Discussion has been revised to better contextualize the study's findings by incorporating a broader range of comparative literature, particularly concerning the relationship between patient age and functional outcomes. These revisions collectively enhance the manuscript's clarity, scientific rigor, and contribution to the existing literature. This revised version of the article incorporates significant enhancements based on feedback from peer review, aimed at improving methodological rigor, transparency, and contextual depth. The Introduction has been substantially rewritten to provide a more comprehensive and updated literature review on midshaft clavicular fractures, including numerous recent references (2020-2025) and a more balanced discussion of treatment outcomes. Methodological reporting has been significantly strengthened throughout. The study design is now explicitly defined as a prospective observational cohort study conducted in accordance with STROBE guidelines. A new STROBE-compliant patient enrollment flowchart (Figure 1) has been added to the Results section to clearly illustrate patient selection. Vague language regarding the study protocol has been replaced with specific details, including a new structured three-phase rehabilitation protocol and clearer descriptions of the outcome measures used. The presentation of data and statistical analysis has also been improved. Patient Body Mass Index (BMI) data has been included in the demographic characteristics (Table 1). The Statistical Analysis section now provides a more explicit description of the correlational tests performed, and the Limitations section transparently addresses the rationale for the statistical methods chosen, including why a multivariate analysis was not feasible. Finally, the Discussion has been revised to better contextualize the study's findings by incorporating a broader range of comparative literature, particularly concerning the relationship between patient age and functional outcomes. These revisions collectively enhance the manuscript's clarity, scientific rigor, and contribution to the existing literature. See the authors' detailed response to the review by Jing-Xin Zhao See the authors' detailed response to the review by Elisa Belluzzi READ REVIEWER RESPONSES Introduction Clavicular fractures represent a significant clinical challenge, comprising 2–5% of all adult fractures, and exhibiting a global incidence ranging from 35 to 84 per 100,000 person-years. Midshaft fractures account for the vast majority of fractures (70–80%). 1 , 2 These injuries are predominantly caused by high-energy trauma, such as road traffic accidents and sports injuries, and are most common in young adult males. 3 , 4 The anatomical vulnerability of the midshaft region contributes to its high fracture frequency, making it a key focus in clinical management. Historically, displaced midshaft clavicular fractures have been managed non-operatively. However, recent evidence challenges this approach, showing nonunion rates of 11–17% and even higher rates of malunion in conservatively treated patients. 5 , 6 While long-term functional outcomes measured by the DASH and Constant-Murley scores may be similar between treatment groups, non-operative management is associated with long-term complications, including residual deformity and patient dissatisfaction. 7 In contrast, operative treatment reduces the risk of nonunion to 0–4% and may offer modest early functional improvements. 8 , 9 However, successful non-operative management remains a focus, with studies identifying factors like residual displacement as key predictors of failure, highlighting the ongoing debate. 10 The shift toward surgical intervention is supported by numerous systematic reviews and meta-analyses, which have confirmed that ORIF significantly lowers the risk of nonunion and malunion. 8 , 9 Among the surgical options, precontoured superior clavicle locking plates offer distinct advantages over traditional plates and intramedullary nailing, including faster union times, lower overall complication rates, and higher patient satisfaction because of their improved anatomical fit and stability. 11 , 12 Patient-specific factors such as younger age, high activity levels, and significant fracture displacement further strengthen the indications for surgery. 3 , 13 In a low-resource setting such as Yemen, where access to care and trauma patterns may differ, understanding treatment outcomes is critical. Given the potential for high-energy trauma in this context, surgical fixation with precontoured locking plates may be particularly valuable for mitigating the risk of non-union. Therefore, this study aimed to evaluate the functional outcomes and complications of precontoured superior clavicle locking plates for displaced midshaft clavicular fractures in a Yemeni cohort, focusing on patient satisfaction, range of motion, union time, and complication rates. Methods Study design This prospective observational cohort study was conducted according to the STROBE guidelines at two centers in Sanaa, Yemen between January 2018 and September 2024. The study protocol was standardized to ensure consistency in patient selection, surgical techniques, postoperative care, and follow-up procedures. Study population Eligible patients were adults (≥18 years) with closed, displaced midshaft clavicular fractures, defined as displacement >2 cm, shortening >2 cm, comminution, or skin-tenting threatening viability. The exclusion criteria were open or pathological fractures, proximal or distal third clavicle involvement, head or neurovascular injuries, acromioclavicular dislocations, and prior non-union. All the participants provided written informed consent. These inclusion criteria were selected because they represent established indications for surgical intervention associated with a higher risk of poor outcomes when managed nonoperatively. Sample size The sample size was calculated based on the primary outcome of the University of California, Los Angeles (UCLA) Shoulder Score. This calculation aimed to ensure sufficient power to detect clinically meaningful outcomes. Based on a Minimal Clinically Important Difference (MCID) of approximately 4 points for the UCLA score (standard deviation 5), as suggested by prior literature on shoulder pathology, 14 , 15 we determined that a minimum of 33 patients would be required to achieve 90% power with α = 0.05. To account for potential dropouts and to enhance the power of subgroup analyses, we aimed for a larger cohort and ultimately enrolled 65 patients. Surgical technique The preoperative workup included standard blood tests and clavicular radiographs (anteroposterior, 20° cranial tilt). Under general anesthesia, the patients were positioned in a beach-chair setup with a scapular sandbag for reduction. Prophylactic antibiotics were administered before incision. A transverse incision below the fracture exposed the clavicle via superior retraction, thereby avoiding a wound overlap with the plate. The subcutaneous tissue and platysma were mobilized together, myofascial layers were incised, and soft tissues were elevated, preserving supraclavicular nerves unless exposure required sacrifice. Fracture reduction was performed using clamps or indirect techniques, as confirmed using fluoroscopy. A 3.5-mm titanium precontoured locking plate (Orthomed E, Egypt) was fixed anterosuperiorly with locking screws, ensuring a minimum of three bicortical screws (i.e., six cortices) per main fragment ; lag screws were used to address butterfly fragments as needed. The fascia was repaired over the plate, the skin was closed in layers, and the arm slung postoperatively. Postoperative care and follow-up The patients received analgesics, postoperative radiographs, and sling immobilization for 4 weeks. The structured rehabilitation protocol was as follows: • Weeks 0–4: Sling immobilization with immediate pendulum, elbow, and wrist exercises. • Weeks 4–8: Sling discontinuation with progression to active shoulder range of motion. • Weeks 8–12 and beyond: Commencement of strengthening exercises with a gradual return to unrestricted activities after 12 weeks, pending radiographic union. Follow-ups at 10 days (suture removal), 4, 8, 12, and 26 weeks were performed. UCLA scores were assessed at 6 months by two orthopedic surgeons, and inter-rater reliability was assessed. Radiographic union was monitored descriptively by the treating surgeon, with delayed union defined as a lack of three-cortex bridging at 12 weeks. Outcome measures The primary outcome was functional recovery, assessed using the UCLA Shoulder Score (max 35), evaluating pain (0–10), function (0–10), active forward flexion (0–5), strength (0–5), and satisfaction (0–5). 16 Scores ≥27 indicated good/excellent outcomes, and <27 fair/poor outcomes. Preoperative scores were not recorded; however, pre-injury shoulder function was queried to exclude any prior pathology. We used the original English version of the score, which was administered verbally by surgeons fluent in both English and Arabic. We acknowledge that a formally validated Arabic translation was not used, which is a limitation of this study. UCLA scores were calculated using the MDCalc online tool ( MDCalc UCLA Shoulder Score Calculator ). Secondary outcomes included complication rates (hardware irritation, failure, infection, delayed union, and malunion). Bias control and variability management To minimize bias, the UCLA Shoulder Scores were independently assessed by two orthopedic surgeons who were uninvolved in patient treatment. Inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC). Based on established guidelines, an ICC of ≥0.80 indicates good reliability . Discrepancies greater than 2 points were reviewed by a third evaluator, and the final scores were determined by consensus. Variability control was ensured through a standardized sample size calculation, uniform follow-up schedule (10 days, 4, 8, 12, and 26 weeks), and consistent rehabilitation protocol. All procedures followed a predefined surgical technique using precontoured superior clavicular locking plates, minimizing technical variations. Statistical analysis Data were analyzed using SPSS version 26 (IBM Corp., Armonk, NY, USA). Descriptive statistics were used to summarize demographic characteristics, injury details, and outcomes. Normality was assessed using the Shapiro-Wilk test. Given the non-normal UCLA score distribution, nonparametric tests (Kruskal-Wallis Mann and–Whitney U) were used to assess subgroup differences. Chi-square tests were used to examine the association between complications, and Spearman’s correlation was used to evaluate the relationship between age and UCLA scores. A p-value <0.05 was considered statistically significant. Results Patient enrollment During the study period, 78 patients with midshaft clavicular fractures were assessed for eligibility to participate. Thirteen patients were excluded because of open fractures (n=7), associated neurovascular injuries (n=4), or declining consent (n=2). The final cohort consisted of 65 patients who met all inclusion criteria and underwent surgical fixation. All 65 enrolled patients completed the 6-month follow-up and were included in the final analysis ( Figure 1 ). Figure 1. Flowchart of patient enrollment. Demographic and injury characteristics Sixty-five patients with displaced midshaft clavicular fractures treated with precontoured locked plates were enrolled. The mean age was 32.09 years (range: 19–50 years), with 54 males (83.1%) and 11 females (16.9%). Road traffic accidents (RTAs) caused the most injuries (n=43, 66.2%), followed by falls (n=22, 33.8%). The right clavicle was affected in 43 (66.2%) patients, and the left clavicle in 22 (33.8%). Table 1 details these traits, and Figures 2 and 3 show representative cases. Table 1. Demographic and injury characteristics. Variable n % Age group 18-30 years 37 56.9% 31-40 years 12 18.5% 41-50 years 16 24.6% Gender Male 54 83.1% Female 11 16.9% BMI (kg/m 2 ), mean ± SD 25.5 ± 3.2 Mode of injury RTA 43 66.2% Accidental fall 22 33.8% Injured side Right 43 66.2% Left 22 33.8% Figure 2. Pre- and postoperative radiographs of a 30-year-old male with displaced midshaft clavicle fracture. (a) Preoperative anteroposterior radiograph showing a displaced, slightly comminuted midshaft fracture of the right clavicle in a 30-year-old male patient. (b) Postoperative anteroposterior radiograph of the same patient after open reduction and internal fixation (ORIF) with a precontoured superior locking plate (Orthomed E, 7-hole, titanium). Note the anatomical reduction of the fracture and the use of locking screws that engage at least four cortices on either side of the fracture. Figure 3. Pre- and postoperative radiographs of a 26-year-old female with comminuted midshaft clavicular fracture. (a) Preoperative anteroposterior radiograph showing a displaced, severely comminuted midshaft fracture of the right clavicle in a 26-year-old female patient. (b) Postoperative anteroposterior radiograph of the same patient after open reduction and internal fixation (ORIF) with a precontoured superior locking plate (Orthomed E, 8-hole, titanium). Note the anatomical reduction of the fracture and the use of locking screws that engage at least four cortices on either side of the fracture. Two lag screws were used to stabilize the butterfly fragments. Functional and radiographic outcomes At 6 months, the mean UCLA shoulder score was 32.46 ± 2.54, with 64 patients (98.5%) achieving good/excellent outcomes (UCLA ≥27) and 1 (1.5%) fair/poor (<27). Table 2 summarizes the scores, and Supplementary Table S1 breaks down the components (Extended Data). Radiographs confirmed union in all cases by 12 weeks (three-cortex bridging), with no delayed unions or malformations. Table 2. UCLA shoulder rating score outcomes. Category Value n % Total UCLA Score (Mean ± SD) 32.46 ± 2.54 Outcome categories Good/excellent (≥27) 64 98.5% Fair/poor (<27) 1 1.5% Patient satisfaction All 65 patients (100%) reported satisfaction with surgical outcomes, reflected in the UCLA Shoulder Rating Score satisfaction component (all scored 5, “Satisfied and better”; Supplementary Table S1(Extended Data)). Postoperative complications Complications were rare and included hardware irritation (n=1, 1.5%), hardware failure (n=2, 3.1%), and superficial infection (n=1, 1.5%) in 6.2% of patients. No delayed unions, malunions, or re-fractures occurred, and 61 patients (93.8%) were complication-free. Table 3 presents the study outcomes are presented in Table 3 . Table 3. Postoperative complications. Complication n % Hardware irritation 1 1.5% Hardware failure 2 3.1% Superficial infection 1 1.5% No complications 61 93.8% Subgroup and correlation analyses UCLA scores and patient characteristics To assess the differences in total UCLA scores across subgroups, we performed Kruskal-Wallis tests for age groups (more than two categories) and Mann-Whitney U tests for sex, injury mechanism, and injured side (two categories each). Spearman’s rank-order correlation was used to examine the relationship between age (a continuous variable) and total UCLA scores. The results are summarized in Table 4 . Table 4. Comparison of total UCLA scores among subgroups. Variable Groups compared Test statistic p-value Age group 18-30, 31-40, 41-50 H(2) = 16.525 < 0.001 Mechanism of injury RTA vs. Fall U = 319.00 0.029 Gender Male vs. Female U = 248.00 0.380 Injured side Right vs. Left U = 203.50 < 0.001 A statistically significant negative correlation was found between age and total UCLA score (ρ = -0.317, p = 0.010), indicating that older patients tended to have lower UCLA scores. Significant differences in the total UCLA scores were also found based on the mechanism of injury (p = 0.029) and the injured side (p < 0.001). Patients with RTA injuries had higher UCLA scores than those with falls and those with right-sided injuries had higher UCLA scores than those with left-sided injuries. No significant differences were observed according to the sex. UCLA component scores and age Kruskal-Wallis tests revealed significant differences across age groups for the pain score (p=0.001) and active forward flexion (p=0.013). Post-hoc tests indicated that the 41-50 age group had significantly better scores (less pain and better flexion) than the 18-30 age group. No significant differences were observed between the age groups in terms of function, strength, or satisfaction components of the UCLA score. Complications and patient characteristics Chi-square tests of independence were performed to examine the relationship between categorical variables (age, mechanism of injury, sex, injured side, and UCLA outcome category) and the occurrence of complications. The results are summarized in Table 5 . A statistically significant association was found between UCLA outcome category and complications (p < 0.001), with patients experiencing complications having worse outcomes, as expected. The Mann–Whitney U test revealed a statistically significant difference in the total UCLA scores between patients with and without complications (U = 11.000, p < 0.001). Patients with complications had significantly lower UCLA scores than those without. Although not statistically significant at p < 0.05, there were trends suggesting possible associations between age group (p=0.051, with a significant linear association of p=0.046), mechanism of injury (p=0.073), and injured side (p=0.073) with complication rates. Table 5. Association between categorical variables and complications. Variable Complications Total Chi-Square/U p-value No, n (%) Yes, n(%) Age group χ 2 (2) = 5.946 0.051 18-30 years 36 (97.3%) 1 (2.7%) 37 31-40 years 12 (100%) 0 (0.0%) 12 41-50 years 13 (81.3%) 3 (18.8%) 16 Linear by linear - - - χ 2 (1) = 3.999 0.046 Mechanism of injury χ 2 (1) = 3.224 0.073 RTA 42 (97.7%) 1 (2.3%) 43 Fall 19 (86.4%) 3 (13.6%) 22 Gender χ 2 (1) = 3.317 0.069 Male 52 (96.3%) 2 (3.7%) 54 Female 9 (81.8%) 2 (18.2%) 11 Injured side χ 2 (1) = 3.224 0.073 Right 42 (97.7%) 1 (2.3%) 43 Left 19 (86.4%) 3 (13.6%) 22 UCLA outcome χ 2 (1) = 15.488 < 0.001 Good/excellent (≥27) 61 (95.3%) 3 (4.7%) 64 Fair/poor (<27) 0 (0.0%) 1 (100%) 1 Total UCLA - - - U = 11.00 < 0.001 Discussion This prospective study evaluated precontoured locked plate fixation for displaced midshaft clavicular fractures in a Yemeni population and observed promising functional outcomes, high patient satisfaction, and a low complication rate. The mean UCLA shoulder rating score of 32.46 at 6 months (98.5% good/excellent results) is consistent with previous reports on plate fixation efficacy. Ethiraj et al. (2016) and Itagi and Kalaskar (2020) documented similarly strong Constant-Murley scores (85.23–97.8). 17 , 18 Moreover, our results align with high-level evidence from the Canadian Orthopaedic Trauma Society (2007) , who established that surgical fixation results in significantly improved functional outcomes and a lower rate of nonunion than nonoperative treatment. 19 Our study adds robust region-specific evidence to the literature supporting surgical intervention for displaced fractures. The subgroup analyses revealed notable patterns that merit further exploration. A significant negative correlation between age and UCLA scores (ρ = -0.317, p = 0.010) suggested that older patients (41–50 years) achieved slightly lower overall function, but paradoxically outperformed younger patients (18–30 years) in pain relief and forward flexion (p = 0.001, p = 0.013). Chue et al. (2018) noted comparable trends, with better pain outcomes in older adults attributable to lower baseline demands or greater relative gains post-ORIF. 20 This finding is echoed in other areas of the shoulder surgery. For example, Ranalletta et al. (2016) found that older age was not a barrier to excellent outcomes after rotator cuff repair, suggesting that patient activity levels and expectations may be more influential than chronology. In our cohort, younger patients, often active males who were injured in RTAs, may have higher recovery expectations, thereby driving subtle dissatisfaction despite healing. Alternatively, age-related differences in soft tissue resilience or rehabilitation adherence could play a role, although the pre-injury function was not quantified in this study. These contradictions highlight the need for tailored outcome metrics across different age groups. Compelling differences in injury mechanisms and laterality were observed. Patients with RTA injuries outperformed those with falls (p = 0.029) and right-sided injuries surpassed left-sided injuries (p < 0.001). Sharma et al. (2021) linked high-energy trauma (e.g., RTAs) to better ORIF outcomes, possibly due to stricter postoperative care, 21 but falls in our study varied in severity, muddying this explanation. Instead, RTA fractures might involve distinct comminution patterns, stabilized effectively by locked plates, whereas falls could skew toward simpler breaks with unrecognized soft tissue impacts. Laterality findings are equally provocative; if most patients are right-handed (data unavailable), dominant-side injuries might spur greater rehabilitation effort, yielding higher symmetry indices, as observed in Riemann et al. (2023). 22 Left-sided repairs, potentially on the non-dominant arms, might result in less patient-driven recovery focus or slight surgical adjustments (e.g., plate contouring challenges on the left clavicle curve). These hypotheses, while speculative, align with the reported variability in shoulder recovery dynamics 23 – 25 and elevate our findings beyond mere observation, warranting targeted biomechanical and behavioral studies. Complications, although rare (6.2%), were strongly correlated with poorer UCLA outcomes (p < 0.001), which is an expected finding consistent with hardware-related setbacks. Compared with the literature rates (e.g., 5–15% for irritation or failure), 14 , 17 , 26 – 29 our results suggest that technical proficiency and patient selection minimized risks, reinforcing ORIF’s safety profile in this setting. Limitations This study had several limitations that limited its conclusions. Foremost, the absence of a control group, whether nonoperative management or alternative fixation (e.g., intramedullary nailing), precludes definitive claims about the superiority of precontoured locked plate fixation despite its promising outcomes. The 6-month follow-up period captures early recovery but misses critical long-term outcomes, such as hardware removal rates, refracture, and chronic dysfunction, which undermine durability assessments. Geographic confinement to two Sana’a and Yemeni centers restricts generalizability, as resource availability and patient profiles may differ elsewhere. Pre-injury UCLA scores were not recorded, hindering the direct measurement of functional gains. Additionally, the 100% satisfaction rate suggests a potential reporting bias or that an insufficiently granular metric—an alternative tool (e.g., DASH)—might reveal variability. These constraints underscore the preliminary nature of our findings and warrant further caution. Additionally, the reported 100% patient satisfaction rate, measured using the single-item component of the UCLA score, should be interpreted with caution. This finding is likely a reflection of the tool’s limited granularity, rather than a perfect outcome for every patient. Even those with minor resolvable complications may report overall satisfaction relative to their preoperative condition. This suggests a potential reporting bias, and future studies should employ more comprehensive patient-reported outcome measures, such as the DASH (Disabilities of the Arm, Shoulder, and Hand) score, to capture a more nuanced view of patient satisfaction. Third, while our overall sample size was robust, the subgroup analyses (e.g., by age group) were based on smaller numbers, which limits the statistical power to detect true differences and increases the risk of Type II error. Furthermore, the low number of complication events (n=4) precluded meaningful multivariate logistic regression analysis to identify independent predictors. Therefore, the findings of these subgroup comparisons should be considered as exploratory. Larger multicenter studies with longer follow-up periods and control groups are needed to confirm these results and assess their long-term efficacy. Exploring subgroup differences (e.g., age, mechanism, and laterality) using biomechanical and patient-reported data could refine treatment strategies. Conclusion This prospective study of 65 Yemeni patients with displaced midshaft clavicular fractures treated via ORIF with pre-contoured locked plates revealed promising early outcomes: a mean UCLA score of 32.46 at 6 months (98.5% good/excellent), radiographic union by 12 weeks, universal patient satisfaction (100%), and a 6.2% complication rate. These findings suggest that this approach is feasible in our cohort, particularly when early mobilization is prioritized. However, the observational design—lacking a control group (e.g., non-operative or nailing)—and 6-month follow-up constrain claims of superiority or long-term benefit, compounded by an unbalanced satisfaction metric. Larger controlled trials with extended follow-up periods are crucial to confirm these results, assess their durability, and guide the management of such fractures. Ethical approval and consent This study was conducted in accordance with the ethical standards of the Institutional Review Board (IRB) of Al-Thawra Modern General Hospital, Sana’a, Yemen, and adhered to the principles of the Declaration of Helsinki (1964) and its later amendments. Ethical approval was obtained from the IRB of Al-Thawra Modern General Hospital before the commencement of the study (Reference Number: IRB-TMGH-2017-047; Approval Date: November 15, 2017). Written informed consent was obtained from all the participants prior to their inclusion in the study. The participants were informed about the study’s purpose, procedures, potential risks, and benefits, and their consent was documented. Additionally, after reviewing a summary of the study contents, all participants provided written consent for the publication of their anonymized data, including radiographic images. Patients consent All participants provided written consent for publication of their anonymized data, including images, after reviewing a summary of the study contents. Data availability Underlying data Figshare Title : Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: Extended Data DOI : https://doi.org/10.6084/m9.figshare.28559558.v3 . 30 This dataset includes anonymized clinical and functional outcome data, postoperative complications, and UCLA scores of patients treated during this study. The following extended data files are included in this repository: • Data_Dictionary.docx – Explanation of variables and coding schema.dataset.csv Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Extended data Figshare Title : Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: Extended Data DOI : https://doi.org/10.6084/m9.figshare.28559558.v3 . 30 License: Creative Commons Attribution 4.0 International (CC-BY 4.0), allowing unrestricted reuse with proper attribution • Supplementary Table S1. docx–UCLA (Refer extended data) Shoulder Rating Score Component Breakdown. Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Reporting guidelines Figshare Title : Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: Extended Data DOI : https://doi.org/10.6084/m9.figshare.28559558.v3 . 30 This study follows the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for reporting observational research. The completed STROBE checklist is available in Figshare under the title: “STROBE Checklist for ‘Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study’”. Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Acknowledgements Preprint: This study was previously published as a preprint: Al-Moaish AA, Algabarty JA, Mughallas A, et al. Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study. Research Square. 12 March 2025. PREPRINT (Version 1). https://doi.org/10.21203/rs.3.rs-6185808/v1 . 31 References 1. Tryggedsson I, Viberg B, Gundtoft PH, et al. : Increasing incidences and changes in treatment trends of clavicle fractures in adults during 2 decades in Denmark: a nationwide study on data from the Danish National Patient Registry. Acta Orthop. 2025; 96 . Publisher Full Text 2. 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Publisher Full Text Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 01 Apr 2025 ADD YOUR COMMENT Comment Author details Author details 1 Department of Orthopedic Surgery, Al-Thawra Modern General Hospital, Sana'a, Yemen 2 Department of Surgery, Sana'a University, Sana'a, Yemen 3 Department of Orthopedic Surgery, Kuwait University Hospital, Sana'a, Yemen Abdullah Ali Al-Moaish Roles: Conceptualization, Investigation, Methodology, Project Administration, Resources, Writing – Original Draft Preparation Jamal Abdulraheem Algabarty Roles: Conceptualization, Data Curation, Methodology, Supervision, Validation, Writing – Review & Editing Anwar Mughallas Roles: Data Curation, Investigation, Writing – Review & Editing Ali Mustafa Alhamzi Roles: Data Curation, Investigation, Methodology Mosleh Soliaman Roles: Investigation, Methodology, Resources Mohammed Hutaif Roles: Data Curation, Methodology, Writing – Review & Editing Mohammed Abdulmoghni Roles: Data Curation, Methodology, Writing – Review & Editing Abdukareem Hussain Almahdi Roles: Data Curation, Investigation, Methodology Haitham Mohammed Jowah Roles: Formal Analysis, Software, Validation, Visualization, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (3) version 3 Revised Published: 28 Aug 2025, 14:374 https://doi.org/10.12688/f1000research.162891.3 version 2 Revised Published: 25 Jun 2025, 14:374 https://doi.org/10.12688/f1000research.162891.2 version 1 Published: 01 Apr 2025, 14:374 https://doi.org/10.12688/f1000research.162891.1 Copyright © 2025 Al-Moaish AA et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Al-Moaish AA, Algabarty JA, Mughallas A et al. Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.12688/f1000research.162891.3 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 3 VERSION 3 PUBLISHED 28 Aug 2025 Revised Views 0 Cite How to cite this report: Belluzzi E. Reviewer Report For: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.5256/f1000research.186918.r409699 ) The direct URL for this report is: https://f1000research.com/articles/14-374/v3#referee-response-409699 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 02 Sep 2025 Elisa Belluzzi , University-Hospital of Padova, Padova, Italy Approved VIEWS 0 https://doi.org/10.5256/f1000research.186918.r409699 The manuscript improved ... Continue reading READ ALL The manuscript improved and can be accepted. Competing Interests: No competing interests were disclosed. Reviewer Expertise: Clinical research, Musculoskeleta diseases I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Belluzzi E. Reviewer Report For: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.5256/f1000research.186918.r409699 ) The direct URL for this report is: https://f1000research.com/articles/14-374/v3#referee-response-409699 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Version 2 VERSION 2 PUBLISHED 25 Jun 2025 Revised Views 0 Cite How to cite this report: Belluzzi E. Reviewer Report For: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.5256/f1000research.183966.r401042 ) The direct URL for this report is: https://f1000research.com/articles/14-374/v2#referee-response-401042 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 19 Aug 2025 Elisa Belluzzi , University-Hospital of Padova, Padova, Italy Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.183966.r401042 My comments are as follows: Introduction is very short. It should be improved. Please update also references. Authors reported that “Historically managed nonoperatively with slings or figure-of-8 braces because of reported low nonunion rates, displaced ... Continue reading READ ALL My comments are as follows: Introduction is very short. It should be improved. Please update also references. Authors reported that “Historically managed nonoperatively with slings or figure-of-8 braces because of reported low nonunion rates, displaced midshaft fractures now show higher nonunion (22–44%), malunion, and dissatisfaction with conservative care.” However, there are published studies reporting a lower nonunion rate (for example: Tagliapietra J, et al., 2020 [Ref 1]). Methods Please explain the design of the study. Is this a prospective cohort study? Please follow the STROBE guidelines for observational studies. Please move the aim of the study at the end of the introduction. Authors reported “A standardized protocol governed patient selection, surgery, postoperative care and follow-up to ensure consistency.” This sentence is unclear. Authors should report the protocol used in detail. The sentence “Data were collected prospectively” should be deleted. Since the authors have already stated that this is a prospective study, it is redundant to mention that data were prospectively collected. Why did authors select to include patients with displacement >2 cm, shortening >2 cm, comminution, or skin tenting threatening viability? Please explain. It is unclear why authors reported UCLA score in postoperative care and follow-up section. In the Outcome Measures section, the authors report the use of the UCLA score and cite a 1981 reference. Could the authors clarify whether they used the original English version of the score or a validated translation? This information is important for assessing the appropriateness and reliability of the outcome measure in their study population. It seems that authors evaluated only the UCLA score and radiographic union as outcomes. Is that correct? Please clarify all the outcomes evaluated in the outcome section, including follow-up times. Authors reported “Variability control was ensured through a standardized sample size calculation, a uniform follow-up schedule (10 days, 4, 8, 12, and 26 weeks), and a consistent rehabilitation protocol.” Again, this sentence is unclear. This part is present also in Postoperative care and follow-up section. Please avoid repeating the same information. Please clarify the rehabilitation protocol used. SPSS version 26 should be cited as suggested by the producer of the software. Please add a flowchart of patients selection at the beginning of the results section. Please add BMI in table 1. Figures should be better prepared. Each panel should have the same dimensions. In the results section authors reported also correlations. However, correlations are lacking in the statistical analysis section. While chi-square tests provide useful univariate associations, a multivariate analysis—such as logistic regression—would be more appropriate to identify independent predictors of complications, especially considering the potential confounding among variables like age, sex, and mechanism of injury. The same for the analysis of UCLA score. Please add. In the discussion authors reported the they found “high patient satisfaction”. However, satisfaction seems to be lacking in the results. Discussion should be improved. The results obtained should be better discussed with published papers. For example, authors cited only one study for age and UCLA scores. Are there other studies? Please add. It is unclear why Canadian Orthopaedic Trauma Society (2007) is written in bold. Is the work clearly and accurately presented and does it cite the current literature? Partly Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? No If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes References 1. Tagliapietra J, Belluzzi E, Biz C, Angelini A, et al.: Midshaft Clavicle Fractures Treated Nonoperatively Using Figure-of-Eight Bandage: Are Fracture Type, Shortening, and Displacement Radiographic Predictors of Failure?. Diagnostics . 2020; 10 (10). Publisher Full Text Competing Interests: No competing interests were disclosed. Reviewer Expertise: Clinical research, Musculoskeleta diseases I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Belluzzi E. Reviewer Report For: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.5256/f1000research.183966.r401042 ) The direct URL for this report is: https://f1000research.com/articles/14-374/v2#referee-response-401042 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 10 Sep 2025 Haitham Jowah , Department of Surgery, Sana'a University, Sana'a, Yemen 10 Sep 2025 Author Response Response to Reviewer 2 Comments Reviewer: Dr. Elisa Belluzzi, University-Hospital of Padova, Padova, Italy Manuscript Title: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study Dear ... Continue reading Response to Reviewer 2 Comments Reviewer: Dr. Elisa Belluzzi, University-Hospital of Padova, Padova, Italy Manuscript Title: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study Dear Dr. Belluzzi, Thank you for your thorough and insightful review of our manuscript. Your feedback has been invaluable in helping us improve the clarity, rigor, and overall quality of our work. We have carefully considered all of your comments and have revised the manuscript accordingly to address each point. Below is our point-by-point response to your suggestions. Introduction Reviewer's Comment: "Introduction is very short. It should be improved. Please update also references... there are published studies reporting a lower nonunion rate (for example: Tagliapietra J, et al., 2020)." Our Response: We agree with your assessment and thank you for this constructive feedback. The Introduction has been substantially rewritten to provide a more comprehensive and updated review of the literature on midshaft clavicular fractures. We have expanded the background on epidemiology and treatment evolution and incorporated numerous recent references (2020-2025). Importantly, following your suggestion, we now present a more balanced discussion on treatment controversies. We have specifically incorporated the Tagliapietra et al. (2020) paper, which was invaluable for contextualizing the radiographic predictors of failure in non-operative management and framing the subsequent shift toward surgical intervention for high-risk fractures. Methods Reviewer's Comment: "Please explain the design of the study. Is this a prospective cohort study?... Please follow the STROBE guidelines... Please move the aim of the study at the end of the introduction... Authors should report the protocol used in detail." Our Response: Thank you for these important structural and methodological suggestions. We have clarified the study design in the "Study design" section, which now explicitly states: " This prospective observational cohort study was conducted according to STROBE guidelines... " The aim of the study has been moved to the final paragraph of the revised Introduction to improve logical flow. We have removed vague language about the protocol and have instead provided specific, detailed descriptions of the patient selection criteria, a new structured three-phase rehabilitation protocol , and the follow-up schedule in their respective sections. Reviewer's Comment: "The sentence 'Data were collected prospectively' should be deleted... Why did authors select to include patients with displacement >2 cm, shortening >2 cm...?" Our Response: The redundant sentence has been deleted. We have added a clear justification in the "Study population" section, explaining that these inclusion criteria represent established indications for surgical intervention, supported by landmark literature, as they are associated with a higher risk of poor outcomes when managed nonoperatively. Reviewer's Comment: "It is unclear why authors reported UCLA score in postoperative care... Could the authors clarify whether they used the original English version of the score or a validated translation?... Please clarify all the outcomes evaluated... including follow-up times." Our Response: We have revised the text for clarity. The timing of the UCLA assessment is now clearly stated. In the "Outcome Measures" section, we have specified that the original English version of the UCLA score was used and verbally administered. We have also acknowledged that a formally validated Arabic translation was not used and have added this as a study limitation. Furthermore, we have expanded this section to clearly delineate the primary and secondary outcomes and their specific assessment timings. Statistical Analysis Reviewer's Comment: "In the results section authors reported also correlations. However, correlations are lacking in the statistical analysis section... While chi-square tests provide useful univariate associations, a multivariate analysis... would be more appropriate." Our Response: We appreciate you highlighting this. We have made the description of Spearman's correlation more explicit in the "Statistical Analysis" section. Regarding multivariate analysis, we agree it represents the ideal approach. However, with only four patients experiencing a complication, a meaningful multivariate logistic regression was not statistically feasible due to the low event rate. We have now transparently addressed this important statistical consideration in our expanded " Limitations " section. Results Reviewer's Comment: "Please add a flowchart of patients selection... Please add BMI in table 1... Figures should be better prepared." Our Response: We have added a new STROBE-compliant patient enrollment flowchart as Figure 1 at the beginning of the Results section. We have also included patient Body Mass Index (BMI) data in Table 1 . The figures have been reformatted to ensure consistent panel dimensions. Discussion Reviewer's Comment: "In the discussion authors reported the they found 'high patient satisfaction'. However, satisfaction seems to be lacking in the results... Discussion should be improved... For example, authors cited only one study for age and UCLA scores." Our Response: Thank you for these points. To ensure this finding is prominent, we have confirmed that it is presented in a dedicated " Patient satisfaction " subsection within the Results. The Discussion has been substantially revised to better contextualize our findings. We have now incorporated a broader range of literature, specifically adding more comparative studies when discussing the relationship between age and functional outcomes to directly address your feedback. Reviewer's Comment: "It is unclear why Canadian Orthopaedic Trauma Society (2007) is written in bold." Our Response: This was an unintentional formatting error, and the bolding has been removed. We believe that these revisions have substantially improved the manuscript, and we are grateful for the time and expertise you dedicated to reviewing our work. Sincerely, The Authors Response to Reviewer 2 Comments Reviewer: Dr. Elisa Belluzzi, University-Hospital of Padova, Padova, Italy Manuscript Title: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study Dear Dr. Belluzzi, Thank you for your thorough and insightful review of our manuscript. Your feedback has been invaluable in helping us improve the clarity, rigor, and overall quality of our work. We have carefully considered all of your comments and have revised the manuscript accordingly to address each point. Below is our point-by-point response to your suggestions. Introduction Reviewer's Comment: "Introduction is very short. It should be improved. Please update also references... there are published studies reporting a lower nonunion rate (for example: Tagliapietra J, et al., 2020)." Our Response: We agree with your assessment and thank you for this constructive feedback. The Introduction has been substantially rewritten to provide a more comprehensive and updated review of the literature on midshaft clavicular fractures. We have expanded the background on epidemiology and treatment evolution and incorporated numerous recent references (2020-2025). Importantly, following your suggestion, we now present a more balanced discussion on treatment controversies. We have specifically incorporated the Tagliapietra et al. (2020) paper, which was invaluable for contextualizing the radiographic predictors of failure in non-operative management and framing the subsequent shift toward surgical intervention for high-risk fractures. Methods Reviewer's Comment: "Please explain the design of the study. Is this a prospective cohort study?... Please follow the STROBE guidelines... Please move the aim of the study at the end of the introduction... Authors should report the protocol used in detail." Our Response: Thank you for these important structural and methodological suggestions. We have clarified the study design in the "Study design" section, which now explicitly states: " This prospective observational cohort study was conducted according to STROBE guidelines... " The aim of the study has been moved to the final paragraph of the revised Introduction to improve logical flow. We have removed vague language about the protocol and have instead provided specific, detailed descriptions of the patient selection criteria, a new structured three-phase rehabilitation protocol , and the follow-up schedule in their respective sections. Reviewer's Comment: "The sentence 'Data were collected prospectively' should be deleted... Why did authors select to include patients with displacement >2 cm, shortening >2 cm...?" Our Response: The redundant sentence has been deleted. We have added a clear justification in the "Study population" section, explaining that these inclusion criteria represent established indications for surgical intervention, supported by landmark literature, as they are associated with a higher risk of poor outcomes when managed nonoperatively. Reviewer's Comment: "It is unclear why authors reported UCLA score in postoperative care... Could the authors clarify whether they used the original English version of the score or a validated translation?... Please clarify all the outcomes evaluated... including follow-up times." Our Response: We have revised the text for clarity. The timing of the UCLA assessment is now clearly stated. In the "Outcome Measures" section, we have specified that the original English version of the UCLA score was used and verbally administered. We have also acknowledged that a formally validated Arabic translation was not used and have added this as a study limitation. Furthermore, we have expanded this section to clearly delineate the primary and secondary outcomes and their specific assessment timings. Statistical Analysis Reviewer's Comment: "In the results section authors reported also correlations. However, correlations are lacking in the statistical analysis section... While chi-square tests provide useful univariate associations, a multivariate analysis... would be more appropriate." Our Response: We appreciate you highlighting this. We have made the description of Spearman's correlation more explicit in the "Statistical Analysis" section. Regarding multivariate analysis, we agree it represents the ideal approach. However, with only four patients experiencing a complication, a meaningful multivariate logistic regression was not statistically feasible due to the low event rate. We have now transparently addressed this important statistical consideration in our expanded " Limitations " section. Results Reviewer's Comment: "Please add a flowchart of patients selection... Please add BMI in table 1... Figures should be better prepared." Our Response: We have added a new STROBE-compliant patient enrollment flowchart as Figure 1 at the beginning of the Results section. We have also included patient Body Mass Index (BMI) data in Table 1 . The figures have been reformatted to ensure consistent panel dimensions. Discussion Reviewer's Comment: "In the discussion authors reported the they found 'high patient satisfaction'. However, satisfaction seems to be lacking in the results... Discussion should be improved... For example, authors cited only one study for age and UCLA scores." Our Response: Thank you for these points. To ensure this finding is prominent, we have confirmed that it is presented in a dedicated " Patient satisfaction " subsection within the Results. The Discussion has been substantially revised to better contextualize our findings. We have now incorporated a broader range of literature, specifically adding more comparative studies when discussing the relationship between age and functional outcomes to directly address your feedback. Reviewer's Comment: "It is unclear why Canadian Orthopaedic Trauma Society (2007) is written in bold." Our Response: This was an unintentional formatting error, and the bolding has been removed. We believe that these revisions have substantially improved the manuscript, and we are grateful for the time and expertise you dedicated to reviewing our work. Sincerely, The Authors Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 10 Sep 2025 Haitham Jowah , Department of Surgery, Sana'a University, Sana'a, Yemen 10 Sep 2025 Author Response Response to Reviewer 2 Comments Reviewer: Dr. Elisa Belluzzi, University-Hospital of Padova, Padova, Italy Manuscript Title: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study Dear ... Continue reading Response to Reviewer 2 Comments Reviewer: Dr. Elisa Belluzzi, University-Hospital of Padova, Padova, Italy Manuscript Title: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study Dear Dr. Belluzzi, Thank you for your thorough and insightful review of our manuscript. Your feedback has been invaluable in helping us improve the clarity, rigor, and overall quality of our work. We have carefully considered all of your comments and have revised the manuscript accordingly to address each point. Below is our point-by-point response to your suggestions. Introduction Reviewer's Comment: "Introduction is very short. It should be improved. Please update also references... there are published studies reporting a lower nonunion rate (for example: Tagliapietra J, et al., 2020)." Our Response: We agree with your assessment and thank you for this constructive feedback. The Introduction has been substantially rewritten to provide a more comprehensive and updated review of the literature on midshaft clavicular fractures. We have expanded the background on epidemiology and treatment evolution and incorporated numerous recent references (2020-2025). Importantly, following your suggestion, we now present a more balanced discussion on treatment controversies. We have specifically incorporated the Tagliapietra et al. (2020) paper, which was invaluable for contextualizing the radiographic predictors of failure in non-operative management and framing the subsequent shift toward surgical intervention for high-risk fractures. Methods Reviewer's Comment: "Please explain the design of the study. Is this a prospective cohort study?... Please follow the STROBE guidelines... Please move the aim of the study at the end of the introduction... Authors should report the protocol used in detail." Our Response: Thank you for these important structural and methodological suggestions. We have clarified the study design in the "Study design" section, which now explicitly states: " This prospective observational cohort study was conducted according to STROBE guidelines... " The aim of the study has been moved to the final paragraph of the revised Introduction to improve logical flow. We have removed vague language about the protocol and have instead provided specific, detailed descriptions of the patient selection criteria, a new structured three-phase rehabilitation protocol , and the follow-up schedule in their respective sections. Reviewer's Comment: "The sentence 'Data were collected prospectively' should be deleted... Why did authors select to include patients with displacement >2 cm, shortening >2 cm...?" Our Response: The redundant sentence has been deleted. We have added a clear justification in the "Study population" section, explaining that these inclusion criteria represent established indications for surgical intervention, supported by landmark literature, as they are associated with a higher risk of poor outcomes when managed nonoperatively. Reviewer's Comment: "It is unclear why authors reported UCLA score in postoperative care... Could the authors clarify whether they used the original English version of the score or a validated translation?... Please clarify all the outcomes evaluated... including follow-up times." Our Response: We have revised the text for clarity. The timing of the UCLA assessment is now clearly stated. In the "Outcome Measures" section, we have specified that the original English version of the UCLA score was used and verbally administered. We have also acknowledged that a formally validated Arabic translation was not used and have added this as a study limitation. Furthermore, we have expanded this section to clearly delineate the primary and secondary outcomes and their specific assessment timings. Statistical Analysis Reviewer's Comment: "In the results section authors reported also correlations. However, correlations are lacking in the statistical analysis section... While chi-square tests provide useful univariate associations, a multivariate analysis... would be more appropriate." Our Response: We appreciate you highlighting this. We have made the description of Spearman's correlation more explicit in the "Statistical Analysis" section. Regarding multivariate analysis, we agree it represents the ideal approach. However, with only four patients experiencing a complication, a meaningful multivariate logistic regression was not statistically feasible due to the low event rate. We have now transparently addressed this important statistical consideration in our expanded " Limitations " section. Results Reviewer's Comment: "Please add a flowchart of patients selection... Please add BMI in table 1... Figures should be better prepared." Our Response: We have added a new STROBE-compliant patient enrollment flowchart as Figure 1 at the beginning of the Results section. We have also included patient Body Mass Index (BMI) data in Table 1 . The figures have been reformatted to ensure consistent panel dimensions. Discussion Reviewer's Comment: "In the discussion authors reported the they found 'high patient satisfaction'. However, satisfaction seems to be lacking in the results... Discussion should be improved... For example, authors cited only one study for age and UCLA scores." Our Response: Thank you for these points. To ensure this finding is prominent, we have confirmed that it is presented in a dedicated " Patient satisfaction " subsection within the Results. The Discussion has been substantially revised to better contextualize our findings. We have now incorporated a broader range of literature, specifically adding more comparative studies when discussing the relationship between age and functional outcomes to directly address your feedback. Reviewer's Comment: "It is unclear why Canadian Orthopaedic Trauma Society (2007) is written in bold." Our Response: This was an unintentional formatting error, and the bolding has been removed. We believe that these revisions have substantially improved the manuscript, and we are grateful for the time and expertise you dedicated to reviewing our work. Sincerely, The Authors Response to Reviewer 2 Comments Reviewer: Dr. Elisa Belluzzi, University-Hospital of Padova, Padova, Italy Manuscript Title: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study Dear Dr. Belluzzi, Thank you for your thorough and insightful review of our manuscript. Your feedback has been invaluable in helping us improve the clarity, rigor, and overall quality of our work. We have carefully considered all of your comments and have revised the manuscript accordingly to address each point. Below is our point-by-point response to your suggestions. Introduction Reviewer's Comment: "Introduction is very short. It should be improved. Please update also references... there are published studies reporting a lower nonunion rate (for example: Tagliapietra J, et al., 2020)." Our Response: We agree with your assessment and thank you for this constructive feedback. The Introduction has been substantially rewritten to provide a more comprehensive and updated review of the literature on midshaft clavicular fractures. We have expanded the background on epidemiology and treatment evolution and incorporated numerous recent references (2020-2025). Importantly, following your suggestion, we now present a more balanced discussion on treatment controversies. We have specifically incorporated the Tagliapietra et al. (2020) paper, which was invaluable for contextualizing the radiographic predictors of failure in non-operative management and framing the subsequent shift toward surgical intervention for high-risk fractures. Methods Reviewer's Comment: "Please explain the design of the study. Is this a prospective cohort study?... Please follow the STROBE guidelines... Please move the aim of the study at the end of the introduction... Authors should report the protocol used in detail." Our Response: Thank you for these important structural and methodological suggestions. We have clarified the study design in the "Study design" section, which now explicitly states: " This prospective observational cohort study was conducted according to STROBE guidelines... " The aim of the study has been moved to the final paragraph of the revised Introduction to improve logical flow. We have removed vague language about the protocol and have instead provided specific, detailed descriptions of the patient selection criteria, a new structured three-phase rehabilitation protocol , and the follow-up schedule in their respective sections. Reviewer's Comment: "The sentence 'Data were collected prospectively' should be deleted... Why did authors select to include patients with displacement >2 cm, shortening >2 cm...?" Our Response: The redundant sentence has been deleted. We have added a clear justification in the "Study population" section, explaining that these inclusion criteria represent established indications for surgical intervention, supported by landmark literature, as they are associated with a higher risk of poor outcomes when managed nonoperatively. Reviewer's Comment: "It is unclear why authors reported UCLA score in postoperative care... Could the authors clarify whether they used the original English version of the score or a validated translation?... Please clarify all the outcomes evaluated... including follow-up times." Our Response: We have revised the text for clarity. The timing of the UCLA assessment is now clearly stated. In the "Outcome Measures" section, we have specified that the original English version of the UCLA score was used and verbally administered. We have also acknowledged that a formally validated Arabic translation was not used and have added this as a study limitation. Furthermore, we have expanded this section to clearly delineate the primary and secondary outcomes and their specific assessment timings. Statistical Analysis Reviewer's Comment: "In the results section authors reported also correlations. However, correlations are lacking in the statistical analysis section... While chi-square tests provide useful univariate associations, a multivariate analysis... would be more appropriate." Our Response: We appreciate you highlighting this. We have made the description of Spearman's correlation more explicit in the "Statistical Analysis" section. Regarding multivariate analysis, we agree it represents the ideal approach. However, with only four patients experiencing a complication, a meaningful multivariate logistic regression was not statistically feasible due to the low event rate. We have now transparently addressed this important statistical consideration in our expanded " Limitations " section. Results Reviewer's Comment: "Please add a flowchart of patients selection... Please add BMI in table 1... Figures should be better prepared." Our Response: We have added a new STROBE-compliant patient enrollment flowchart as Figure 1 at the beginning of the Results section. We have also included patient Body Mass Index (BMI) data in Table 1 . The figures have been reformatted to ensure consistent panel dimensions. Discussion Reviewer's Comment: "In the discussion authors reported the they found 'high patient satisfaction'. However, satisfaction seems to be lacking in the results... Discussion should be improved... For example, authors cited only one study for age and UCLA scores." Our Response: Thank you for these points. To ensure this finding is prominent, we have confirmed that it is presented in a dedicated " Patient satisfaction " subsection within the Results. The Discussion has been substantially revised to better contextualize our findings. We have now incorporated a broader range of literature, specifically adding more comparative studies when discussing the relationship between age and functional outcomes to directly address your feedback. Reviewer's Comment: "It is unclear why Canadian Orthopaedic Trauma Society (2007) is written in bold." Our Response: This was an unintentional formatting error, and the bolding has been removed. We believe that these revisions have substantially improved the manuscript, and we are grateful for the time and expertise you dedicated to reviewing our work. Sincerely, The Authors Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Zhao JX. Reviewer Report For: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.5256/f1000research.183966.r394763 ) The direct URL for this report is: https://f1000research.com/articles/14-374/v2#referee-response-394763 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 11 Aug 2025 Jing-Xin Zhao , Chinese PLA General Hospital, Beijing, China Approved VIEWS 0 https://doi.org/10.5256/f1000research.183966.r394763 Thanks very much for the author's revisions. I have no ... Continue reading READ ALL Thanks very much for the author's revisions. I have no further comments on the revised version. Congratulations to the authors! Competing Interests: No competing interests were disclosed. Reviewer Expertise: Orthopedics I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Zhao JX. Reviewer Report For: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.5256/f1000research.183966.r394763 ) The direct URL for this report is: https://f1000research.com/articles/14-374/v2#referee-response-394763 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Version 1 VERSION 1 PUBLISHED 01 Apr 2025 Views 0 Cite How to cite this report: Zhao JX. Reviewer Report For: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.5256/f1000research.179162.r384316 ) The direct URL for this report is: https://f1000research.com/articles/14-374/v1#referee-response-384316 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 16 Jun 2025 Jing-Xin Zhao , Chinese PLA General Hospital, Beijing, China Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.179162.r384316 This article reports the treatment experience of clavicle fracture fixation with plates in the Yemen region. After reading this article, I have the following suggestions that can be used to improve it. 1. There is no control ... Continue reading READ ALL This article reports the treatment experience of clavicle fracture fixation with plates in the Yemen region. After reading this article, I have the following suggestions that can be used to improve it. 1. There is no control group. What is the basis for calculating the sample size? Assuming a 4-point difference (standard deviation 5), α = 0.05, and 90% power, at least 33 patients are required. Who is the difference between? 2. "Locking screws (≥ 3 cortical layers per fragment)" What is the basis for fixing each bone fragment with 3 layers of cortical bone? Our common sense suggests that at least 4 layers of cortical bone should be used for fixation. 3. "The inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC), with an ICC of ≥ 0.80 indicating excellent agreement." What is the basis for "ICC ≥ 0.80 indicates excellent agreement"? The literature mentions "substantial" rather than "excellent". There is a difference between the two. 4. Refer to Table 3. All 65 patients (100%) reported satisfaction with the surgical outcomes. Why would there still be 100% satisfaction when there were complications? 5. Refer to "UCLA component scores and age" No significant differences were observed in terms of function, strength, or satisfaction. Between what? Furthermore, subgroup analysis was performed with Age group: 18-30, 31-40, 41-50. What is the basis for this? Is the sample size sufficient? 6. [Discussion] reported UCLA means above reinforcing our findings. This literature is about intramedullary nails, not steel plates. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Partly Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? No Are the conclusions drawn adequately supported by the results? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: Orthopedics I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Zhao JX. Reviewer Report For: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.5256/f1000research.179162.r384316 ) The direct URL for this report is: https://f1000research.com/articles/14-374/v1#referee-response-384316 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 11 Sep 2025 Haitham Jowah , Department of Surgery, Sana'a University, Sana'a, Yemen 11 Sep 2025 Author Response Date: 22 June 2025 Subject: Response to Reviewer Comments on Manuscript ID F1000Research-162891.1 Dear Dr. Jing-Xin Zhao, Thank you for your time and for providing a thorough and insightful review ... Continue reading Date: 22 June 2025 Subject: Response to Reviewer Comments on Manuscript ID F1000Research-162891.1 Dear Dr. Jing-Xin Zhao, Thank you for your time and for providing a thorough and insightful review of our manuscript, "Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study" (F1000Research-162891.1). We appreciate your constructive feedback and "approved with reservations" status. Your comments have helped us identify several areas where our manuscript can be improved for clarity, precision, and methodological rigor. We have carefully considered each of your points and have prepared a point-by-point response below. We believe the incorporated changes have substantially strengthened the manuscript. Point-by-Point Response to Reviewer Comments Reviewer Comment 1: There is no control group. What is the basis for calculating the sample size? Assuming a 4-point difference (standard deviation 5), α = 0.05, and 90% power, at least 33 patients are required. Who is the difference between? Author Response: Thank you for this important question regarding the sample size calculation. We acknowledge that the wording in the manuscript was ambiguous. As this is a prospective single-arm observational study, the sample size was not calculated to detect a difference between two groups. Instead, it was based on the concept of a Minimal Clinically Important Difference (MCID) for the UCLA Shoulder Score. The "4-point difference" refers to the MCID for the UCLA score, which represents the smallest change in score that patients would perceive as beneficial. Our goal was to ensure our study was powered to estimate the mean UCLA score with adequate precision. We have clarified this in the revised manuscript. Proposed change in the "Sample size" section: “The sample size was calculated based on the primary outcome, the University of California, Los Angeles (UCLA) Shoulder Score. The calculation aimed to ensure sufficient power to detect a clinically meaningful outcome. Based on a Minimal Clinically Important Difference (MCID) of approximately 4 points for the UCLA score (standard deviation 5), as suggested by prior literature on shoulder pathology, 8,9 we determined that a minimum of 33 patients would be required to achieve 90% power with α = 0.05. To account for potential dropouts and to enhance the power for subgroup analyses, we aimed for a larger cohort and ultimately enrolled 65 patients.” Reviewer Comment 2: "Locking screws (≥ 3 cortical layers per fragment)" What is the basis for fixing each bone fragment with 3 layers of cortical bone? Our common sense suggests that at least 4 layers of cortical bone should be used for fixation. Author Response: We are grateful to the reviewer for pointing out this significant error in our description. You are absolutely correct; standard surgical practice dictates a more robust fixation, and our phrasing was inaccurate. Our standard technique involves using a minimum of three bicortical screws on each side of the main fracture fragment, which equates to six cortices of fixation . We have corrected the manuscript text to accurately reflect our procedure. Proposed change in the "Surgical technique" section: “…A 3.5-mm titanium precontoured locking plate (Orthomed E, Egypt) was fixed anterosuperiorly with locking screws, ensuring a minimum of three bicortical screws (i.e., six cortices) per main fragment ; lag screws were used to address butterfly fragments as needed.” Reviewer Comment 3: "The inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC), with an ICC of ≥ 0.80 indicating excellent agreement." What is the basis for "ICC ≥ 0.80 indicates excellent agreement"? The literature mentions "substantial" rather than "excellent". There is a difference between the two. Author Response: Thank you for this point on terminological precision. We agree that the classification of ICC values can vary. We have amended the text to use more widely accepted terminology ("good reliability") and have added a citation to support this classification. Proposed change in the "Bias control and variability management" section: “Inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC). Based on established guidelines, an ICC value between 0.75 and 0.90 is considered to indicate good reliability . Our achieved ICC of ≥0.80 reflects good agreement between assessors.” Reviewer Comment 4: Refer to Table 3. All 65 patients (100%) reported satisfaction with the surgical outcomes. Why would there still be 100% satisfaction when there were complications? Author Response: This is an excellent and very important observation. We recognize that a 100% satisfaction rate, especially in the presence of complications, is highly unusual and suggests a limitation in our measurement tool. We have added a paragraph to the "Limitations" section to explicitly address this point. Proposed addition to the "Limitations" section: “Additionally, the reported 100% patient satisfaction rate, measured via the single-item component of the UCLA score, should be interpreted with caution. This finding is likely a reflection of the tool's limited granularity rather than a perfect outcome for every patient. Even those with minor, resolvable complications may have reported overall satisfaction relative to their pre-operative condition. This suggests a potential reporting bias, and future studies should employ more comprehensive patient-reported outcome measures, such as the DASH (Disabilities of the Arm, Shoulder and Hand) score, to capture a more nuanced view of patient satisfaction.” Reviewer Comment 5: Refer to "UCLA component scores and age" No significant differences were observed in terms of function, strength, or satisfaction. Between what? Furthermore, subgroup analysis was performed with Age group: 18-30, 31-40, 41-50. What is the basis for this? Is the sample size sufficient? Author Response: Thank you for requesting clarification. The comparison was indeed between the three defined age groups, and we have revised the sentence for clarity. We also agree that the sample sizes for these subgroup analyses are small and have added this as a study limitation. Proposed change in the "UCLA component scores and age" section: “No significant differences were observed between the age groups in terms of the function, strength, or satisfaction components of the UCLA score.” Proposed addition to the "Limitations" section: “Third, while our overall sample size was robust, the subgroup analyses (e.g., by age group) were based on smaller numbers, which limits the statistical power to detect true differences and increases the risk of a Type II error. The findings from these subgroup comparisons should therefore be considered exploratory.” Reviewer Comment 6: [Discussion] reported UCLA means above reinforcing our findings. This literature is about intramedullary nails, not steel plates. Author Response: We sincerely thank the reviewer for their careful reading and for catching this significant error. We have removed the incorrect reference (Wijdicks et al., 2013) and replaced it with a citation to the landmark 2007 randomized trial by the Canadian Orthopaedic Trauma Society (COTS), which is highly relevant to plate fixation for midshaft clavicle fractures. We have revised the discussion paragraph accordingly, ensuring the new reference is correctly cited as number 13. Revised "Discussion" paragraph: This prospective study evaluated precontoured locked plate fixation for displaced midshaft clavicular fractures in a Yemeni population and observed promising functional outcomes, high patient satisfaction, and a low complication rate. The mean UCLA shoulder rating score of 32.46 at 6 months (98.5% good/excellent results) is consistent with previous reports on plate fixation efficacy, such as those by Ethiraj et al. (2016) and Itagi and Kalaskar (2020) who documented similarly strong Constant-Murley scores. 11,12 Moreover, our results align with high-level evidence from the Canadian Orthopaedic Trauma Society (2007) , whose multicenter randomized trial established that surgical fixation results in significantly improved functional outcomes and a lower rate of nonunion versus nonoperative treatment. 13 Our study therefore adds robust, region-specific evidence to the literature supporting surgical intervention for displaced fractures. Once again, we thank you for your invaluable contributions to improving our manuscript. We believe the proposed revisions address all your concerns and have substantially strengthened the paper. We look forward to your further review of the revised submission. Sincerely, Dr. Haitham Mohammed Jowah Corresponding Author (on behalf of all authors) Date: 22 June 2025 Subject: Response to Reviewer Comments on Manuscript ID F1000Research-162891.1 Dear Dr. Jing-Xin Zhao, Thank you for your time and for providing a thorough and insightful review of our manuscript, "Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study" (F1000Research-162891.1). We appreciate your constructive feedback and "approved with reservations" status. Your comments have helped us identify several areas where our manuscript can be improved for clarity, precision, and methodological rigor. We have carefully considered each of your points and have prepared a point-by-point response below. We believe the incorporated changes have substantially strengthened the manuscript. Point-by-Point Response to Reviewer Comments Reviewer Comment 1: There is no control group. What is the basis for calculating the sample size? Assuming a 4-point difference (standard deviation 5), α = 0.05, and 90% power, at least 33 patients are required. Who is the difference between? Author Response: Thank you for this important question regarding the sample size calculation. We acknowledge that the wording in the manuscript was ambiguous. As this is a prospective single-arm observational study, the sample size was not calculated to detect a difference between two groups. Instead, it was based on the concept of a Minimal Clinically Important Difference (MCID) for the UCLA Shoulder Score. The "4-point difference" refers to the MCID for the UCLA score, which represents the smallest change in score that patients would perceive as beneficial. Our goal was to ensure our study was powered to estimate the mean UCLA score with adequate precision. We have clarified this in the revised manuscript. Proposed change in the "Sample size" section: “The sample size was calculated based on the primary outcome, the University of California, Los Angeles (UCLA) Shoulder Score. The calculation aimed to ensure sufficient power to detect a clinically meaningful outcome. Based on a Minimal Clinically Important Difference (MCID) of approximately 4 points for the UCLA score (standard deviation 5), as suggested by prior literature on shoulder pathology, 8,9 we determined that a minimum of 33 patients would be required to achieve 90% power with α = 0.05. To account for potential dropouts and to enhance the power for subgroup analyses, we aimed for a larger cohort and ultimately enrolled 65 patients.” Reviewer Comment 2: "Locking screws (≥ 3 cortical layers per fragment)" What is the basis for fixing each bone fragment with 3 layers of cortical bone? Our common sense suggests that at least 4 layers of cortical bone should be used for fixation. Author Response: We are grateful to the reviewer for pointing out this significant error in our description. You are absolutely correct; standard surgical practice dictates a more robust fixation, and our phrasing was inaccurate. Our standard technique involves using a minimum of three bicortical screws on each side of the main fracture fragment, which equates to six cortices of fixation . We have corrected the manuscript text to accurately reflect our procedure. Proposed change in the "Surgical technique" section: “…A 3.5-mm titanium precontoured locking plate (Orthomed E, Egypt) was fixed anterosuperiorly with locking screws, ensuring a minimum of three bicortical screws (i.e., six cortices) per main fragment ; lag screws were used to address butterfly fragments as needed.” Reviewer Comment 3: "The inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC), with an ICC of ≥ 0.80 indicating excellent agreement." What is the basis for "ICC ≥ 0.80 indicates excellent agreement"? The literature mentions "substantial" rather than "excellent". There is a difference between the two. Author Response: Thank you for this point on terminological precision. We agree that the classification of ICC values can vary. We have amended the text to use more widely accepted terminology ("good reliability") and have added a citation to support this classification. Proposed change in the "Bias control and variability management" section: “Inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC). Based on established guidelines, an ICC value between 0.75 and 0.90 is considered to indicate good reliability . Our achieved ICC of ≥0.80 reflects good agreement between assessors.” Reviewer Comment 4: Refer to Table 3. All 65 patients (100%) reported satisfaction with the surgical outcomes. Why would there still be 100% satisfaction when there were complications? Author Response: This is an excellent and very important observation. We recognize that a 100% satisfaction rate, especially in the presence of complications, is highly unusual and suggests a limitation in our measurement tool. We have added a paragraph to the "Limitations" section to explicitly address this point. Proposed addition to the "Limitations" section: “Additionally, the reported 100% patient satisfaction rate, measured via the single-item component of the UCLA score, should be interpreted with caution. This finding is likely a reflection of the tool's limited granularity rather than a perfect outcome for every patient. Even those with minor, resolvable complications may have reported overall satisfaction relative to their pre-operative condition. This suggests a potential reporting bias, and future studies should employ more comprehensive patient-reported outcome measures, such as the DASH (Disabilities of the Arm, Shoulder and Hand) score, to capture a more nuanced view of patient satisfaction.” Reviewer Comment 5: Refer to "UCLA component scores and age" No significant differences were observed in terms of function, strength, or satisfaction. Between what? Furthermore, subgroup analysis was performed with Age group: 18-30, 31-40, 41-50. What is the basis for this? Is the sample size sufficient? Author Response: Thank you for requesting clarification. The comparison was indeed between the three defined age groups, and we have revised the sentence for clarity. We also agree that the sample sizes for these subgroup analyses are small and have added this as a study limitation. Proposed change in the "UCLA component scores and age" section: “No significant differences were observed between the age groups in terms of the function, strength, or satisfaction components of the UCLA score.” Proposed addition to the "Limitations" section: “Third, while our overall sample size was robust, the subgroup analyses (e.g., by age group) were based on smaller numbers, which limits the statistical power to detect true differences and increases the risk of a Type II error. The findings from these subgroup comparisons should therefore be considered exploratory.” Reviewer Comment 6: [Discussion] reported UCLA means above reinforcing our findings. This literature is about intramedullary nails, not steel plates. Author Response: We sincerely thank the reviewer for their careful reading and for catching this significant error. We have removed the incorrect reference (Wijdicks et al., 2013) and replaced it with a citation to the landmark 2007 randomized trial by the Canadian Orthopaedic Trauma Society (COTS), which is highly relevant to plate fixation for midshaft clavicle fractures. We have revised the discussion paragraph accordingly, ensuring the new reference is correctly cited as number 13. Revised "Discussion" paragraph: This prospective study evaluated precontoured locked plate fixation for displaced midshaft clavicular fractures in a Yemeni population and observed promising functional outcomes, high patient satisfaction, and a low complication rate. The mean UCLA shoulder rating score of 32.46 at 6 months (98.5% good/excellent results) is consistent with previous reports on plate fixation efficacy, such as those by Ethiraj et al. (2016) and Itagi and Kalaskar (2020) who documented similarly strong Constant-Murley scores. 11,12 Moreover, our results align with high-level evidence from the Canadian Orthopaedic Trauma Society (2007) , whose multicenter randomized trial established that surgical fixation results in significantly improved functional outcomes and a lower rate of nonunion versus nonoperative treatment. 13 Our study therefore adds robust, region-specific evidence to the literature supporting surgical intervention for displaced fractures. Once again, we thank you for your invaluable contributions to improving our manuscript. We believe the proposed revisions address all your concerns and have substantially strengthened the paper. We look forward to your further review of the revised submission. Sincerely, Dr. Haitham Mohammed Jowah Corresponding Author (on behalf of all authors) Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 11 Sep 2025 Haitham Jowah , Department of Surgery, Sana'a University, Sana'a, Yemen 11 Sep 2025 Author Response Date: 22 June 2025 Subject: Response to Reviewer Comments on Manuscript ID F1000Research-162891.1 Dear Dr. Jing-Xin Zhao, Thank you for your time and for providing a thorough and insightful review ... Continue reading Date: 22 June 2025 Subject: Response to Reviewer Comments on Manuscript ID F1000Research-162891.1 Dear Dr. Jing-Xin Zhao, Thank you for your time and for providing a thorough and insightful review of our manuscript, "Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study" (F1000Research-162891.1). We appreciate your constructive feedback and "approved with reservations" status. Your comments have helped us identify several areas where our manuscript can be improved for clarity, precision, and methodological rigor. We have carefully considered each of your points and have prepared a point-by-point response below. We believe the incorporated changes have substantially strengthened the manuscript. Point-by-Point Response to Reviewer Comments Reviewer Comment 1: There is no control group. What is the basis for calculating the sample size? Assuming a 4-point difference (standard deviation 5), α = 0.05, and 90% power, at least 33 patients are required. Who is the difference between? Author Response: Thank you for this important question regarding the sample size calculation. We acknowledge that the wording in the manuscript was ambiguous. As this is a prospective single-arm observational study, the sample size was not calculated to detect a difference between two groups. Instead, it was based on the concept of a Minimal Clinically Important Difference (MCID) for the UCLA Shoulder Score. The "4-point difference" refers to the MCID for the UCLA score, which represents the smallest change in score that patients would perceive as beneficial. Our goal was to ensure our study was powered to estimate the mean UCLA score with adequate precision. We have clarified this in the revised manuscript. Proposed change in the "Sample size" section: “The sample size was calculated based on the primary outcome, the University of California, Los Angeles (UCLA) Shoulder Score. The calculation aimed to ensure sufficient power to detect a clinically meaningful outcome. Based on a Minimal Clinically Important Difference (MCID) of approximately 4 points for the UCLA score (standard deviation 5), as suggested by prior literature on shoulder pathology, 8,9 we determined that a minimum of 33 patients would be required to achieve 90% power with α = 0.05. To account for potential dropouts and to enhance the power for subgroup analyses, we aimed for a larger cohort and ultimately enrolled 65 patients.” Reviewer Comment 2: "Locking screws (≥ 3 cortical layers per fragment)" What is the basis for fixing each bone fragment with 3 layers of cortical bone? Our common sense suggests that at least 4 layers of cortical bone should be used for fixation. Author Response: We are grateful to the reviewer for pointing out this significant error in our description. You are absolutely correct; standard surgical practice dictates a more robust fixation, and our phrasing was inaccurate. Our standard technique involves using a minimum of three bicortical screws on each side of the main fracture fragment, which equates to six cortices of fixation . We have corrected the manuscript text to accurately reflect our procedure. Proposed change in the "Surgical technique" section: “…A 3.5-mm titanium precontoured locking plate (Orthomed E, Egypt) was fixed anterosuperiorly with locking screws, ensuring a minimum of three bicortical screws (i.e., six cortices) per main fragment ; lag screws were used to address butterfly fragments as needed.” Reviewer Comment 3: "The inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC), with an ICC of ≥ 0.80 indicating excellent agreement." What is the basis for "ICC ≥ 0.80 indicates excellent agreement"? The literature mentions "substantial" rather than "excellent". There is a difference between the two. Author Response: Thank you for this point on terminological precision. We agree that the classification of ICC values can vary. We have amended the text to use more widely accepted terminology ("good reliability") and have added a citation to support this classification. Proposed change in the "Bias control and variability management" section: “Inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC). Based on established guidelines, an ICC value between 0.75 and 0.90 is considered to indicate good reliability . Our achieved ICC of ≥0.80 reflects good agreement between assessors.” Reviewer Comment 4: Refer to Table 3. All 65 patients (100%) reported satisfaction with the surgical outcomes. Why would there still be 100% satisfaction when there were complications? Author Response: This is an excellent and very important observation. We recognize that a 100% satisfaction rate, especially in the presence of complications, is highly unusual and suggests a limitation in our measurement tool. We have added a paragraph to the "Limitations" section to explicitly address this point. Proposed addition to the "Limitations" section: “Additionally, the reported 100% patient satisfaction rate, measured via the single-item component of the UCLA score, should be interpreted with caution. This finding is likely a reflection of the tool's limited granularity rather than a perfect outcome for every patient. Even those with minor, resolvable complications may have reported overall satisfaction relative to their pre-operative condition. This suggests a potential reporting bias, and future studies should employ more comprehensive patient-reported outcome measures, such as the DASH (Disabilities of the Arm, Shoulder and Hand) score, to capture a more nuanced view of patient satisfaction.” Reviewer Comment 5: Refer to "UCLA component scores and age" No significant differences were observed in terms of function, strength, or satisfaction. Between what? Furthermore, subgroup analysis was performed with Age group: 18-30, 31-40, 41-50. What is the basis for this? Is the sample size sufficient? Author Response: Thank you for requesting clarification. The comparison was indeed between the three defined age groups, and we have revised the sentence for clarity. We also agree that the sample sizes for these subgroup analyses are small and have added this as a study limitation. Proposed change in the "UCLA component scores and age" section: “No significant differences were observed between the age groups in terms of the function, strength, or satisfaction components of the UCLA score.” Proposed addition to the "Limitations" section: “Third, while our overall sample size was robust, the subgroup analyses (e.g., by age group) were based on smaller numbers, which limits the statistical power to detect true differences and increases the risk of a Type II error. The findings from these subgroup comparisons should therefore be considered exploratory.” Reviewer Comment 6: [Discussion] reported UCLA means above reinforcing our findings. This literature is about intramedullary nails, not steel plates. Author Response: We sincerely thank the reviewer for their careful reading and for catching this significant error. We have removed the incorrect reference (Wijdicks et al., 2013) and replaced it with a citation to the landmark 2007 randomized trial by the Canadian Orthopaedic Trauma Society (COTS), which is highly relevant to plate fixation for midshaft clavicle fractures. We have revised the discussion paragraph accordingly, ensuring the new reference is correctly cited as number 13. Revised "Discussion" paragraph: This prospective study evaluated precontoured locked plate fixation for displaced midshaft clavicular fractures in a Yemeni population and observed promising functional outcomes, high patient satisfaction, and a low complication rate. The mean UCLA shoulder rating score of 32.46 at 6 months (98.5% good/excellent results) is consistent with previous reports on plate fixation efficacy, such as those by Ethiraj et al. (2016) and Itagi and Kalaskar (2020) who documented similarly strong Constant-Murley scores. 11,12 Moreover, our results align with high-level evidence from the Canadian Orthopaedic Trauma Society (2007) , whose multicenter randomized trial established that surgical fixation results in significantly improved functional outcomes and a lower rate of nonunion versus nonoperative treatment. 13 Our study therefore adds robust, region-specific evidence to the literature supporting surgical intervention for displaced fractures. Once again, we thank you for your invaluable contributions to improving our manuscript. We believe the proposed revisions address all your concerns and have substantially strengthened the paper. We look forward to your further review of the revised submission. Sincerely, Dr. Haitham Mohammed Jowah Corresponding Author (on behalf of all authors) Date: 22 June 2025 Subject: Response to Reviewer Comments on Manuscript ID F1000Research-162891.1 Dear Dr. Jing-Xin Zhao, Thank you for your time and for providing a thorough and insightful review of our manuscript, "Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study" (F1000Research-162891.1). We appreciate your constructive feedback and "approved with reservations" status. Your comments have helped us identify several areas where our manuscript can be improved for clarity, precision, and methodological rigor. We have carefully considered each of your points and have prepared a point-by-point response below. We believe the incorporated changes have substantially strengthened the manuscript. Point-by-Point Response to Reviewer Comments Reviewer Comment 1: There is no control group. What is the basis for calculating the sample size? Assuming a 4-point difference (standard deviation 5), α = 0.05, and 90% power, at least 33 patients are required. Who is the difference between? Author Response: Thank you for this important question regarding the sample size calculation. We acknowledge that the wording in the manuscript was ambiguous. As this is a prospective single-arm observational study, the sample size was not calculated to detect a difference between two groups. Instead, it was based on the concept of a Minimal Clinically Important Difference (MCID) for the UCLA Shoulder Score. The "4-point difference" refers to the MCID for the UCLA score, which represents the smallest change in score that patients would perceive as beneficial. Our goal was to ensure our study was powered to estimate the mean UCLA score with adequate precision. We have clarified this in the revised manuscript. Proposed change in the "Sample size" section: “The sample size was calculated based on the primary outcome, the University of California, Los Angeles (UCLA) Shoulder Score. The calculation aimed to ensure sufficient power to detect a clinically meaningful outcome. Based on a Minimal Clinically Important Difference (MCID) of approximately 4 points for the UCLA score (standard deviation 5), as suggested by prior literature on shoulder pathology, 8,9 we determined that a minimum of 33 patients would be required to achieve 90% power with α = 0.05. To account for potential dropouts and to enhance the power for subgroup analyses, we aimed for a larger cohort and ultimately enrolled 65 patients.” Reviewer Comment 2: "Locking screws (≥ 3 cortical layers per fragment)" What is the basis for fixing each bone fragment with 3 layers of cortical bone? Our common sense suggests that at least 4 layers of cortical bone should be used for fixation. Author Response: We are grateful to the reviewer for pointing out this significant error in our description. You are absolutely correct; standard surgical practice dictates a more robust fixation, and our phrasing was inaccurate. Our standard technique involves using a minimum of three bicortical screws on each side of the main fracture fragment, which equates to six cortices of fixation . We have corrected the manuscript text to accurately reflect our procedure. Proposed change in the "Surgical technique" section: “…A 3.5-mm titanium precontoured locking plate (Orthomed E, Egypt) was fixed anterosuperiorly with locking screws, ensuring a minimum of three bicortical screws (i.e., six cortices) per main fragment ; lag screws were used to address butterfly fragments as needed.” Reviewer Comment 3: "The inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC), with an ICC of ≥ 0.80 indicating excellent agreement." What is the basis for "ICC ≥ 0.80 indicates excellent agreement"? The literature mentions "substantial" rather than "excellent". There is a difference between the two. Author Response: Thank you for this point on terminological precision. We agree that the classification of ICC values can vary. We have amended the text to use more widely accepted terminology ("good reliability") and have added a citation to support this classification. Proposed change in the "Bias control and variability management" section: “Inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC). Based on established guidelines, an ICC value between 0.75 and 0.90 is considered to indicate good reliability . Our achieved ICC of ≥0.80 reflects good agreement between assessors.” Reviewer Comment 4: Refer to Table 3. All 65 patients (100%) reported satisfaction with the surgical outcomes. Why would there still be 100% satisfaction when there were complications? Author Response: This is an excellent and very important observation. We recognize that a 100% satisfaction rate, especially in the presence of complications, is highly unusual and suggests a limitation in our measurement tool. We have added a paragraph to the "Limitations" section to explicitly address this point. Proposed addition to the "Limitations" section: “Additionally, the reported 100% patient satisfaction rate, measured via the single-item component of the UCLA score, should be interpreted with caution. This finding is likely a reflection of the tool's limited granularity rather than a perfect outcome for every patient. Even those with minor, resolvable complications may have reported overall satisfaction relative to their pre-operative condition. This suggests a potential reporting bias, and future studies should employ more comprehensive patient-reported outcome measures, such as the DASH (Disabilities of the Arm, Shoulder and Hand) score, to capture a more nuanced view of patient satisfaction.” Reviewer Comment 5: Refer to "UCLA component scores and age" No significant differences were observed in terms of function, strength, or satisfaction. Between what? Furthermore, subgroup analysis was performed with Age group: 18-30, 31-40, 41-50. What is the basis for this? Is the sample size sufficient? Author Response: Thank you for requesting clarification. The comparison was indeed between the three defined age groups, and we have revised the sentence for clarity. We also agree that the sample sizes for these subgroup analyses are small and have added this as a study limitation. Proposed change in the "UCLA component scores and age" section: “No significant differences were observed between the age groups in terms of the function, strength, or satisfaction components of the UCLA score.” Proposed addition to the "Limitations" section: “Third, while our overall sample size was robust, the subgroup analyses (e.g., by age group) were based on smaller numbers, which limits the statistical power to detect true differences and increases the risk of a Type II error. The findings from these subgroup comparisons should therefore be considered exploratory.” Reviewer Comment 6: [Discussion] reported UCLA means above reinforcing our findings. This literature is about intramedullary nails, not steel plates. Author Response: We sincerely thank the reviewer for their careful reading and for catching this significant error. We have removed the incorrect reference (Wijdicks et al., 2013) and replaced it with a citation to the landmark 2007 randomized trial by the Canadian Orthopaedic Trauma Society (COTS), which is highly relevant to plate fixation for midshaft clavicle fractures. We have revised the discussion paragraph accordingly, ensuring the new reference is correctly cited as number 13. Revised "Discussion" paragraph: This prospective study evaluated precontoured locked plate fixation for displaced midshaft clavicular fractures in a Yemeni population and observed promising functional outcomes, high patient satisfaction, and a low complication rate. The mean UCLA shoulder rating score of 32.46 at 6 months (98.5% good/excellent results) is consistent with previous reports on plate fixation efficacy, such as those by Ethiraj et al. (2016) and Itagi and Kalaskar (2020) who documented similarly strong Constant-Murley scores. 11,12 Moreover, our results align with high-level evidence from the Canadian Orthopaedic Trauma Society (2007) , whose multicenter randomized trial established that surgical fixation results in significantly improved functional outcomes and a lower rate of nonunion versus nonoperative treatment. 13 Our study therefore adds robust, region-specific evidence to the literature supporting surgical intervention for displaced fractures. Once again, we thank you for your invaluable contributions to improving our manuscript. We believe the proposed revisions address all your concerns and have substantially strengthened the paper. We look forward to your further review of the revised submission. Sincerely, Dr. Haitham Mohammed Jowah Corresponding Author (on behalf of all authors) Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 01 Apr 2025 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 Version 3 (revision) 28 Aug 25 read Version 2 (revision) 25 Jun 25 read read Version 1 01 Apr 25 read Jing-Xin Zhao , Chinese PLA General Hospital, Beijing, China Elisa Belluzzi , University-Hospital of Padova, Padova, Italy Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Belluzzi E. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 02 Sep 2025 | for Version 3 Elisa Belluzzi , University-Hospital of Padova, Padova, Italy 0 Views copyright © 2025 Belluzzi E. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions The manuscript improved and can be accepted. Competing Interests No competing interests were disclosed. Reviewer Expertise Clinical research, Musculoskeleta diseases I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Belluzzi E. Peer Review Report For: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.5256/f1000research.186918.r409699) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-374/v3#referee-response-409699 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Belluzzi E. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 19 Aug 2025 | for Version 2 Elisa Belluzzi , University-Hospital of Padova, Padova, Italy 0 Views copyright © 2025 Belluzzi E. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions My comments are as follows: Introduction is very short. It should be improved. Please update also references. Authors reported that “Historically managed nonoperatively with slings or figure-of-8 braces because of reported low nonunion rates, displaced midshaft fractures now show higher nonunion (22–44%), malunion, and dissatisfaction with conservative care.” However, there are published studies reporting a lower nonunion rate (for example: Tagliapietra J, et al., 2020 [Ref 1]). Methods Please explain the design of the study. Is this a prospective cohort study? Please follow the STROBE guidelines for observational studies. Please move the aim of the study at the end of the introduction. Authors reported “A standardized protocol governed patient selection, surgery, postoperative care and follow-up to ensure consistency.” This sentence is unclear. Authors should report the protocol used in detail. The sentence “Data were collected prospectively” should be deleted. Since the authors have already stated that this is a prospective study, it is redundant to mention that data were prospectively collected. Why did authors select to include patients with displacement >2 cm, shortening >2 cm, comminution, or skin tenting threatening viability? Please explain. It is unclear why authors reported UCLA score in postoperative care and follow-up section. In the Outcome Measures section, the authors report the use of the UCLA score and cite a 1981 reference. Could the authors clarify whether they used the original English version of the score or a validated translation? This information is important for assessing the appropriateness and reliability of the outcome measure in their study population. It seems that authors evaluated only the UCLA score and radiographic union as outcomes. Is that correct? Please clarify all the outcomes evaluated in the outcome section, including follow-up times. Authors reported “Variability control was ensured through a standardized sample size calculation, a uniform follow-up schedule (10 days, 4, 8, 12, and 26 weeks), and a consistent rehabilitation protocol.” Again, this sentence is unclear. This part is present also in Postoperative care and follow-up section. Please avoid repeating the same information. Please clarify the rehabilitation protocol used. SPSS version 26 should be cited as suggested by the producer of the software. Please add a flowchart of patients selection at the beginning of the results section. Please add BMI in table 1. Figures should be better prepared. Each panel should have the same dimensions. In the results section authors reported also correlations. However, correlations are lacking in the statistical analysis section. While chi-square tests provide useful univariate associations, a multivariate analysis—such as logistic regression—would be more appropriate to identify independent predictors of complications, especially considering the potential confounding among variables like age, sex, and mechanism of injury. The same for the analysis of UCLA score. Please add. In the discussion authors reported the they found “high patient satisfaction”. However, satisfaction seems to be lacking in the results. Discussion should be improved. The results obtained should be better discussed with published papers. For example, authors cited only one study for age and UCLA scores. Are there other studies? Please add. It is unclear why Canadian Orthopaedic Trauma Society (2007) is written in bold. Is the work clearly and accurately presented and does it cite the current literature? Partly Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? No If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes References 1. Tagliapietra J, Belluzzi E, Biz C, Angelini A, et al.: Midshaft Clavicle Fractures Treated Nonoperatively Using Figure-of-Eight Bandage: Are Fracture Type, Shortening, and Displacement Radiographic Predictors of Failure?. Diagnostics . 2020; 10 (10). Publisher Full Text Competing Interests No competing interests were disclosed. Reviewer Expertise Clinical research, Musculoskeleta diseases I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 10 Sep 2025 Haitham Jowah, Department of Surgery, Sana'a University, Sana'a, Yemen Response to Reviewer 2 Comments Reviewer: Dr. Elisa Belluzzi, University-Hospital of Padova, Padova, Italy Manuscript Title: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study Dear Dr. Belluzzi, Thank you for your thorough and insightful review of our manuscript. Your feedback has been invaluable in helping us improve the clarity, rigor, and overall quality of our work. We have carefully considered all of your comments and have revised the manuscript accordingly to address each point. Below is our point-by-point response to your suggestions. Introduction Reviewer's Comment: "Introduction is very short. It should be improved. Please update also references... there are published studies reporting a lower nonunion rate (for example: Tagliapietra J, et al., 2020)." Our Response: We agree with your assessment and thank you for this constructive feedback. The Introduction has been substantially rewritten to provide a more comprehensive and updated review of the literature on midshaft clavicular fractures. We have expanded the background on epidemiology and treatment evolution and incorporated numerous recent references (2020-2025). Importantly, following your suggestion, we now present a more balanced discussion on treatment controversies. We have specifically incorporated the Tagliapietra et al. (2020) paper, which was invaluable for contextualizing the radiographic predictors of failure in non-operative management and framing the subsequent shift toward surgical intervention for high-risk fractures. Methods Reviewer's Comment: "Please explain the design of the study. Is this a prospective cohort study?... Please follow the STROBE guidelines... Please move the aim of the study at the end of the introduction... Authors should report the protocol used in detail." Our Response: Thank you for these important structural and methodological suggestions. We have clarified the study design in the "Study design" section, which now explicitly states: " This prospective observational cohort study was conducted according to STROBE guidelines... " The aim of the study has been moved to the final paragraph of the revised Introduction to improve logical flow. We have removed vague language about the protocol and have instead provided specific, detailed descriptions of the patient selection criteria, a new structured three-phase rehabilitation protocol , and the follow-up schedule in their respective sections. Reviewer's Comment: "The sentence 'Data were collected prospectively' should be deleted... Why did authors select to include patients with displacement >2 cm, shortening >2 cm...?" Our Response: The redundant sentence has been deleted. We have added a clear justification in the "Study population" section, explaining that these inclusion criteria represent established indications for surgical intervention, supported by landmark literature, as they are associated with a higher risk of poor outcomes when managed nonoperatively. Reviewer's Comment: "It is unclear why authors reported UCLA score in postoperative care... Could the authors clarify whether they used the original English version of the score or a validated translation?... Please clarify all the outcomes evaluated... including follow-up times." Our Response: We have revised the text for clarity. The timing of the UCLA assessment is now clearly stated. In the "Outcome Measures" section, we have specified that the original English version of the UCLA score was used and verbally administered. We have also acknowledged that a formally validated Arabic translation was not used and have added this as a study limitation. Furthermore, we have expanded this section to clearly delineate the primary and secondary outcomes and their specific assessment timings. Statistical Analysis Reviewer's Comment: "In the results section authors reported also correlations. However, correlations are lacking in the statistical analysis section... While chi-square tests provide useful univariate associations, a multivariate analysis... would be more appropriate." Our Response: We appreciate you highlighting this. We have made the description of Spearman's correlation more explicit in the "Statistical Analysis" section. Regarding multivariate analysis, we agree it represents the ideal approach. However, with only four patients experiencing a complication, a meaningful multivariate logistic regression was not statistically feasible due to the low event rate. We have now transparently addressed this important statistical consideration in our expanded " Limitations " section. Results Reviewer's Comment: "Please add a flowchart of patients selection... Please add BMI in table 1... Figures should be better prepared." Our Response: We have added a new STROBE-compliant patient enrollment flowchart as Figure 1 at the beginning of the Results section. We have also included patient Body Mass Index (BMI) data in Table 1 . The figures have been reformatted to ensure consistent panel dimensions. Discussion Reviewer's Comment: "In the discussion authors reported the they found 'high patient satisfaction'. However, satisfaction seems to be lacking in the results... Discussion should be improved... For example, authors cited only one study for age and UCLA scores." Our Response: Thank you for these points. To ensure this finding is prominent, we have confirmed that it is presented in a dedicated " Patient satisfaction " subsection within the Results. The Discussion has been substantially revised to better contextualize our findings. We have now incorporated a broader range of literature, specifically adding more comparative studies when discussing the relationship between age and functional outcomes to directly address your feedback. Reviewer's Comment: "It is unclear why Canadian Orthopaedic Trauma Society (2007) is written in bold." Our Response: This was an unintentional formatting error, and the bolding has been removed. We believe that these revisions have substantially improved the manuscript, and we are grateful for the time and expertise you dedicated to reviewing our work. Sincerely, The Authors View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Belluzzi E. Peer Review Report For: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.5256/f1000research.183966.r401042) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-374/v2#referee-response-401042 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Zhao J. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 11 Aug 2025 | for Version 2 Jing-Xin Zhao , Chinese PLA General Hospital, Beijing, China 0 Views copyright © 2025 Zhao J. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Thanks very much for the author's revisions. I have no further comments on the revised version. Congratulations to the authors! Competing Interests No competing interests were disclosed. Reviewer Expertise Orthopedics I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Zhao JX. Peer Review Report For: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.5256/f1000research.183966.r394763) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-374/v2#referee-response-394763 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Zhao J. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 16 Jun 2025 | for Version 1 Jing-Xin Zhao , Chinese PLA General Hospital, Beijing, China 0 Views copyright © 2025 Zhao J. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This article reports the treatment experience of clavicle fracture fixation with plates in the Yemen region. After reading this article, I have the following suggestions that can be used to improve it. 1. There is no control group. What is the basis for calculating the sample size? Assuming a 4-point difference (standard deviation 5), α = 0.05, and 90% power, at least 33 patients are required. Who is the difference between? 2. "Locking screws (≥ 3 cortical layers per fragment)" What is the basis for fixing each bone fragment with 3 layers of cortical bone? Our common sense suggests that at least 4 layers of cortical bone should be used for fixation. 3. "The inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC), with an ICC of ≥ 0.80 indicating excellent agreement." What is the basis for "ICC ≥ 0.80 indicates excellent agreement"? The literature mentions "substantial" rather than "excellent". There is a difference between the two. 4. Refer to Table 3. All 65 patients (100%) reported satisfaction with the surgical outcomes. Why would there still be 100% satisfaction when there were complications? 5. Refer to "UCLA component scores and age" No significant differences were observed in terms of function, strength, or satisfaction. Between what? Furthermore, subgroup analysis was performed with Age group: 18-30, 31-40, 41-50. What is the basis for this? Is the sample size sufficient? 6. [Discussion] reported UCLA means above reinforcing our findings. This literature is about intramedullary nails, not steel plates. Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Partly Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? No Are the conclusions drawn adequately supported by the results? Partly Competing Interests No competing interests were disclosed. Reviewer Expertise Orthopedics I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 11 Sep 2025 Haitham Jowah, Department of Surgery, Sana'a University, Sana'a, Yemen Date: 22 June 2025 Subject: Response to Reviewer Comments on Manuscript ID F1000Research-162891.1 Dear Dr. Jing-Xin Zhao, Thank you for your time and for providing a thorough and insightful review of our manuscript, "Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study" (F1000Research-162891.1). We appreciate your constructive feedback and "approved with reservations" status. Your comments have helped us identify several areas where our manuscript can be improved for clarity, precision, and methodological rigor. We have carefully considered each of your points and have prepared a point-by-point response below. We believe the incorporated changes have substantially strengthened the manuscript. Point-by-Point Response to Reviewer Comments Reviewer Comment 1: There is no control group. What is the basis for calculating the sample size? Assuming a 4-point difference (standard deviation 5), α = 0.05, and 90% power, at least 33 patients are required. Who is the difference between? Author Response: Thank you for this important question regarding the sample size calculation. We acknowledge that the wording in the manuscript was ambiguous. As this is a prospective single-arm observational study, the sample size was not calculated to detect a difference between two groups. Instead, it was based on the concept of a Minimal Clinically Important Difference (MCID) for the UCLA Shoulder Score. The "4-point difference" refers to the MCID for the UCLA score, which represents the smallest change in score that patients would perceive as beneficial. Our goal was to ensure our study was powered to estimate the mean UCLA score with adequate precision. We have clarified this in the revised manuscript. Proposed change in the "Sample size" section: “The sample size was calculated based on the primary outcome, the University of California, Los Angeles (UCLA) Shoulder Score. The calculation aimed to ensure sufficient power to detect a clinically meaningful outcome. Based on a Minimal Clinically Important Difference (MCID) of approximately 4 points for the UCLA score (standard deviation 5), as suggested by prior literature on shoulder pathology, 8,9 we determined that a minimum of 33 patients would be required to achieve 90% power with α = 0.05. To account for potential dropouts and to enhance the power for subgroup analyses, we aimed for a larger cohort and ultimately enrolled 65 patients.” Reviewer Comment 2: "Locking screws (≥ 3 cortical layers per fragment)" What is the basis for fixing each bone fragment with 3 layers of cortical bone? Our common sense suggests that at least 4 layers of cortical bone should be used for fixation. Author Response: We are grateful to the reviewer for pointing out this significant error in our description. You are absolutely correct; standard surgical practice dictates a more robust fixation, and our phrasing was inaccurate. Our standard technique involves using a minimum of three bicortical screws on each side of the main fracture fragment, which equates to six cortices of fixation . We have corrected the manuscript text to accurately reflect our procedure. Proposed change in the "Surgical technique" section: “…A 3.5-mm titanium precontoured locking plate (Orthomed E, Egypt) was fixed anterosuperiorly with locking screws, ensuring a minimum of three bicortical screws (i.e., six cortices) per main fragment ; lag screws were used to address butterfly fragments as needed.” Reviewer Comment 3: "The inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC), with an ICC of ≥ 0.80 indicating excellent agreement." What is the basis for "ICC ≥ 0.80 indicates excellent agreement"? The literature mentions "substantial" rather than "excellent". There is a difference between the two. Author Response: Thank you for this point on terminological precision. We agree that the classification of ICC values can vary. We have amended the text to use more widely accepted terminology ("good reliability") and have added a citation to support this classification. Proposed change in the "Bias control and variability management" section: “Inter-rater reliability was evaluated using the Intraclass Correlation Coefficient (ICC). Based on established guidelines, an ICC value between 0.75 and 0.90 is considered to indicate good reliability . Our achieved ICC of ≥0.80 reflects good agreement between assessors.” Reviewer Comment 4: Refer to Table 3. All 65 patients (100%) reported satisfaction with the surgical outcomes. Why would there still be 100% satisfaction when there were complications? Author Response: This is an excellent and very important observation. We recognize that a 100% satisfaction rate, especially in the presence of complications, is highly unusual and suggests a limitation in our measurement tool. We have added a paragraph to the "Limitations" section to explicitly address this point. Proposed addition to the "Limitations" section: “Additionally, the reported 100% patient satisfaction rate, measured via the single-item component of the UCLA score, should be interpreted with caution. This finding is likely a reflection of the tool's limited granularity rather than a perfect outcome for every patient. Even those with minor, resolvable complications may have reported overall satisfaction relative to their pre-operative condition. This suggests a potential reporting bias, and future studies should employ more comprehensive patient-reported outcome measures, such as the DASH (Disabilities of the Arm, Shoulder and Hand) score, to capture a more nuanced view of patient satisfaction.” Reviewer Comment 5: Refer to "UCLA component scores and age" No significant differences were observed in terms of function, strength, or satisfaction. Between what? Furthermore, subgroup analysis was performed with Age group: 18-30, 31-40, 41-50. What is the basis for this? Is the sample size sufficient? Author Response: Thank you for requesting clarification. The comparison was indeed between the three defined age groups, and we have revised the sentence for clarity. We also agree that the sample sizes for these subgroup analyses are small and have added this as a study limitation. Proposed change in the "UCLA component scores and age" section: “No significant differences were observed between the age groups in terms of the function, strength, or satisfaction components of the UCLA score.” Proposed addition to the "Limitations" section: “Third, while our overall sample size was robust, the subgroup analyses (e.g., by age group) were based on smaller numbers, which limits the statistical power to detect true differences and increases the risk of a Type II error. The findings from these subgroup comparisons should therefore be considered exploratory.” Reviewer Comment 6: [Discussion] reported UCLA means above reinforcing our findings. This literature is about intramedullary nails, not steel plates. Author Response: We sincerely thank the reviewer for their careful reading and for catching this significant error. We have removed the incorrect reference (Wijdicks et al., 2013) and replaced it with a citation to the landmark 2007 randomized trial by the Canadian Orthopaedic Trauma Society (COTS), which is highly relevant to plate fixation for midshaft clavicle fractures. We have revised the discussion paragraph accordingly, ensuring the new reference is correctly cited as number 13. Revised "Discussion" paragraph: This prospective study evaluated precontoured locked plate fixation for displaced midshaft clavicular fractures in a Yemeni population and observed promising functional outcomes, high patient satisfaction, and a low complication rate. The mean UCLA shoulder rating score of 32.46 at 6 months (98.5% good/excellent results) is consistent with previous reports on plate fixation efficacy, such as those by Ethiraj et al. (2016) and Itagi and Kalaskar (2020) who documented similarly strong Constant-Murley scores. 11,12 Moreover, our results align with high-level evidence from the Canadian Orthopaedic Trauma Society (2007) , whose multicenter randomized trial established that surgical fixation results in significantly improved functional outcomes and a lower rate of nonunion versus nonoperative treatment. 13 Our study therefore adds robust, region-specific evidence to the literature supporting surgical intervention for displaced fractures. Once again, we thank you for your invaluable contributions to improving our manuscript. We believe the proposed revisions address all your concerns and have substantially strengthened the paper. We look forward to your further review of the revised submission. Sincerely, Dr. Haitham Mohammed Jowah Corresponding Author (on behalf of all authors) View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Zhao JX. Peer Review Report For: Functional Outcomes of Displaced Midshaft Clavicular Fractures Treated with Precontoured Locked Plates: A Prospective Study [version 3; peer review: 2 approved] . F1000Research 2025, 14 :374 ( https://doi.org/10.5256/f1000research.179162.r384316) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-374/v1#referee-response-384316 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions Adjust parameters to alter display View on desktop for interactive features Includes Interactive Elements View on desktop for interactive features Competing Interests Policy Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. 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