One-week X-ray control in acute proximal humeral fractures conservatively treated. Prospective randomized multicentric study.

One-week X-ray control in acute proximal humeral fractures conservatively treated. 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Prospective randomized multicentric study. Carlos Torrens, Ivet Parés-Alfonso, Elisa Cassart, Laura Valls, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6435848/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Purpose Conservatively treated proximal humeral fractures (PHF) are often re-evaluated via X-ray after one-week to detect further displacements of the fracture that may require surgery. The objective of this study was to evaluate the need for a one-week X-ray evaluation of the conservatively treated PHF. Methods Prospective randomized multicentric study involving 4 centers that included the conservatively treated PHF. Patients were randomized to group I (one-week X-Ray assessment) and to group II (without X-ray assessment). Pain was assessed with the VAS at weeks 1 and 3 and at 3, 6,12 months. The Constant Score and Simple Shoulder Test were recorded at 6- and 12-months. Complications were also recorded at any point. Results A total of 143 patients were included. The mean age of the patients included was 69.01 years. There were 114 women and 29 men. There were 52 one-part, 58 two-part, 32 three-part and 1 four-part fracture. Group 1 consisted of 73 patients and 70 were allocated to group II. There were no significant differences between the two groups in terms of age, gender, dominance, and type of fracture. No statistically significant differences were noted between the 2 groups relative to the VAS at 1 week (p = 0.914), 3 weeks (p = 0.351), 3- (p = 0.229), 6- (p = 0.353), 12- month (p = 0.559). Neither were there any differences in the Constant Score at 6- (63.68 vs 64.22, p = 0.871), and 12-month (70.74 vs 70.82, p = 0.982) or the SST at 6 (p = 0.864) and 12-month (p = 0.319). Two patients in group I required further surgery. There were 8 complications (6 in group I, 4 in group II) (p = 0.945). Conclusions Based on the results of this study, a one-week control X-Ray is not necessary in conservatively treated PHF. Proximal humeral fracture conservative treatment non-operative imaging X-Ray control Figures Figure 1 INTRODUCTION Proximal humeral fractures (PHF) are still a source of debate due to the lack of consensus on the best treatment for each case. The same fracture pattern can be treated conservatively or surgically depending on the surgeon's criteria [1–7]. There is a lack of consensus of the 2 treatments perform. Furthermore, there is no consensus around the immobilization time required if conservative treatment is decided upon. Furthermore, a determination of the periodicity of imaging controls to perform until fracture consolidation is achieved is not clear [8,9]. A recent study analyses the need or not to conduct periodic imaging studies on conservatively treated non-displaced fractures of the proximal humerus. The study authors concluded that periodic imaging studies are unnecessary in 77% of the cases [9]. However, what has not been studied is whether periodic imaging studies should be conducted or their periodicity when treating displaced fractures of the proximal humerus conservatively. Hypothetically, there is always a greater risk of secondary displacement in these cases. The factors that predispose to secondary displacement of these fractures (such as alcohol abuse or osteoporosis) have been analyzed. However, no analysis was done of how this displacement may affect the outcome of the fracture, or whether it conditions a change in treatment [10]. The main concern when treating a displaced proximal humeral fracture conservatively is that further displacement may happen within the first days. Additionally, that displacement may condition a change in the treatment, usually meaning a change to a surgical treatment. Knowing whether periodic imaging studies are needed or not needed in these patients might reduce the number of complementary explorations done as well as the number of check-ups necessary. That would be relevant given the high incidence rate of this type of fracture and the prospect of that rate increasing in the coming years [11,12]. The main objective of this study was to determine whether it is necessary to perform a control X-ray study one week after the initial fracture, particularly when a displaced proximal humeral fracture has been treated conservatively, to detect possible secondary displacements that may result due to a change in the treatment. MATERIAL AND METHODS Study Design A prospective randomized multicenter study was designed to evaluate whether an X-ray assessment after one week of the fracture was needed for the conservatively treated PFH. This study involved 4 different centers. Enrollment began in February 2021 and ended in November 2021. After opening a sealed opaque envelope containing the group number obtained from a computer-generated randomization list, the patients were allocated to either group I (with one-week X-Ray assessment) or group II (without X-ray assessment). The type of randomization was simple randomization. All included patients were followed for 1 year. Participants were enrolled during the first check-up, at 1 week after the fracture, after assessment of the inclusion and exclusion criteria. Inclusion and exclusion criteria The inclusion criteria were patients over 18 and below 85 years old, acute PHF, conservative treatment agreement, and the absence of a previous pathology of the affected shoulder. The exclusion criteria were cognitive deterioration and medical injuries that made it impossible to carry out a proper rehabilitation program as well as patient unwillingness to participate in the study. The decision to perform a surgical or conservative treatment was made after considering age, functional demand, and the fracture pattern. It was determined in accordance with the criteria of each shoulder surgeon from the different participating institutions. The fracture pattern was assessed by means of the initial X-ray study (including the anteroposterior and outlet view) and after the analysis of a computed tomography (CT) scan obtained on the same day as the initial X-ray. Treatment Regimen All the patients from both groups were immobilized for three weeks with a sling bandage with restriction of arm rotation. Regardless of the group to which the patients were assigned, they were instructed to do passive elbow movements 5 times a day from the first day after the fracture. After the immobilization period of three weeks, all the patients followed the same progressive rehabilitation program, which included both self-assisted exercises at home and supervised exercises in a rehabilitation center. Outcomes The functional outcome was evaluated at 6- and 12-months follow-up using the Constant score expressed in absolute values [13]. To assess the functional disability of the shoulder, a self-reported shoulder-specific questionnaire, the Simple Shoulder Test (SST), was also used at the 6- and 12-month follow-ups. The pain was assessed using a Visual analogue scale (VAS) that was administered at 1 week after the fracture, at 3 weeks, and then at the 3, 6 and 12-month follow-ups. Radiographs (anteroposterior and outlet views) were obtained at the 1-week follow-up for the patients in Group 1. After the one-week visit, radiographs were obtained for both groups at the 3-, 6- and 12-month follow-ups. All the PHFs included were classified following the Neer classification system [14]. Given the known low reproducibility and concordance of the Neer classification system, fractures were classified based on a consensus reached among the shoulder surgeons in each center after reviewing the radiographs and the CT scans. Complications including stiffness, non-union, osteonecrosis and the need for a subsequent surgery were also recorded for both groups. Those complications were also recorded for patients in group II that, for whatever reason, required a one-week X-ray exam. All the clinical assessments were done by an independent observer blinded to the group in which the patient was allocated. All the included patients signed informed consent forms to participate in this study. This study was approved by the Parc de Salut Mar Ethical Committee (2021/9694/I) and registered at ClinicalTrials.gov (NCT04651543). Statistical analysis With a sample size calculation accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 45 subjects in the first group and 45 in the second group were required to detect a difference equal to or greater than 10 units on Constant's Functional scale. The common standard deviation was assumed to be approximately 15 units. A loss to follow-up rate of 20% was estimated. Previously to the statistical analysis, changes were calculated for each variable (12 months – 6 months). Continuous variables, including the calculated differences, were described as mean and standard deviations. Qualitative variables were described with frequency tables (number and percentage). Between group differences were assessed with the Student t-test for continuous variables and the Chi-square or Fisher exact test, as appropriate, for categorical variables. Statistical analyses were performed using STATA 15.1. The results were considered statistically significant at p-value < 0.05. RESULTS In the period from February 2021 to November 2021, 145 patient-candidates were included. Two of them were excluded due to severe dementia, leaving a total of 143 patients to be included. After randomization, 73 patients were assigned to group I and got the radiological assessment at one-week. The remaining 70 were assigned to group II and did not get the radiological assessment. There were 2 patients who died during the follow-up period, and 21 patients were lost during the follow-up for unknown reasons. That left 120 patients for the final analysis (Fig. 1). The mean age of the 143 patients included was 69.01 years (range, 19 to 94 years). There were 114 women and 29 men. The left arm was affected in 62 cases and the right arm in 81 cases. Most of the patients were right-handed, 124 vs. 19 cases. In the Neer classification system, there were 52 one-part fractures, 58 two-part fractures, 32 three-part fractures and 1 four-part fracture. The two groups were comparable in terms of age, gender, laterality, hand dominance, and fracture classification distribution, without significant differences between them (Table 1). No significant differences between the two groups were found in terms of functional outcomes as measured with the Constant score at 6 months (63.68 group I vs 64.22 group II, p = 0.871), and at 12-months (70.74 group I vs 70.82 group II, p = 0.982). Moreover, there were no differences in the Constant subscale scores (pain, daily living activities, forward elevation, abduction, lateral rotation, internal rotation, and strength) between the groups (Table 2). No statistically significant differences were noted between the two groups in terms of pain as measured with the VAS at 1 week (6.04group I vs 6.09 group II, p = 0.914), 3 weeks (4.49 group I vs 4.07 group II, p = 0.351), 3 months (2.69 group I vs 2.16 group II, p = 0.229), 6 months (2.11 group I vs 1.7 group II p = 0.353), and 12 months (1.47 group I vs 1.36 group II, p = 0.559) (Table 2). No significant differences between the two groups were found in the scores on the SST questionnaire items at 6 months (p = 0.864) and 12 months (p = 0.319) (Table II). Moreover, no significant differences were found between the two groups relative to complications (p =0.945). There were 8 complications (5.6%) reported during the follow-up period. Of those, there were 4 cases of stiffness (2 in group I and 2 in group II), 2 cases of avascular necrosis and stiffness in group I, 1 avascular necrosis in group I, and 1 non-union in group II. Two patients required surgery; both were included in the group I with the one-week X-Ray assessment. One was due to avascular necrosis that was detected at the 10-month follow-up and required a reverse shoulder arthroplasty. The other one was due to stiffness over 8-months that followed by arthroscopic releases. No other patients in either group required further surgery or a change in the treatment regimen. In one patient assigned to group II, a one-week X-ray was considered necessary and was subsequently ordered. However, it did not lead to any change in the treatment regimen. At the follow-up, the patient was not experiencing any complication. The patient was analyzed in group II as per intention to treat. DISCUSSION The best treatment for PHF is yet undetermined and as controversial as is the need for radiological assessment and its frequency when a non-operative treatment is chosen [1–9,15–20]. The results of the present study suggest that there is no need to ask for a one-week X-ray exam to analyze potential fracture displacements in conservatively treated proximal humeral fractures. With that, no change in treatment regimen is expected, the complication rate will not change, and the functional and quality-of-life outcomes will not change either. When treating proximal humeral fractures conservatively, one of the major concerns is that there may be further displacement. If that occurs, surgical treatment can be offered instead of conservative. This is quite often the main reason the early imaging exam is requested if conservative treatment is decided. It is done to detect further displacement of the fracture early enough to be able to address it surgically. However, surgery is seldom needed when proximal humeral fractures are conservatively treated [9,21,22]. Moreover, only two patients required surgery in the present study. That decision was taken at 8 and 10-months after the fractures due to stiffness and avascular necrosis, not because of further displacement of the fracture. In addition, different patterns of the same fracture can be observed when obtaining serial X-ray exams. It was not because of fracture displacement but because of aberrant beam paths [23]. For both reasons, the role of early imaging assessment of conservatively treated fractures is suspect. A recent study investigated the need for secondary surgery to detect secondary displacement in 100 one-part PHF as well as the functional result [7]. One group underwent routine radiological assessment while the other did so only if persistent pain was present. They concluded from their results that serial radiological evaluation of patients with a one-part PHF was only needed in those cases with comminution as serial radiological evaluation did not identify more displacement and thereby change the indication of conservative management. Only 4 out of the 100 patients included needed operative treatment because of secondary displacement [9]. These results are consistent with those obtained in the present study where only 2 out of 119 patients required surgical treatment. In the present study, not only one-part fractures were analyzed but also 2-, 3- and 4-part fractures. This is validation that even displaced fractures can be followed without the need for serial imaging exam. Attempts to define risk factors for secondary displacement have been made in several studies [9,10]. Age and gender do not seem to influence secondary displacement. Neither does the pattern of the fracture as defined by the Neer classification system seem to be predictive of secondary displacement. However, severe osteoarthritis, osteoporosis, alcohol abuse and the disruption of the medial hinge and or comminution are relevant when assessing secondary displacement. In the present study, secondary displacement of the fractures included was not assessed. It was thought that if secondary displacement was relevant enough, it would be reflected in the functional and/or quality of life outcomes. As it would be in the number and type of complications. It was presumed that if the displacement would not affect outcomes and complications, then it could be overlooked. The results of the present study failed to find differences in outcomes and complications between patients having a Week-1 X-ray control and those without the X-ray control, meaning that there are no clinical consequences if further displacement has happened. Moreover, a one-week X-ray was ordered in one patient of the group without X-ray control because of the fracture pattern, but there was no change made in the treatment regimen after the X-ray assessment. In addition, the patient did not present any complication at the 1-year follow-up. Frequently, and only because it has traditionally been done that way, we subject our patients to some overtreatment. In conservatively treated Proximal humeral fractures, it has been demonstrated that the immobilization period can be reduced in a safe way. It can be done without compromising outcomes and complications, allowing patients to freely use their injured arm to not compromise patient independence. The present study demonstrates that there is no need to obtain a one-week X-ray control in conservatively treated Proximal humeral fractures since this does not influence outcomes or complications. By doing that, the patient does not have to have extra visits and they are saved greater X-ray radiation exposure. This may also have an impact on orthopedic and imaging departments, both organizationally and economically, because of the ever increasing number of PHF. Among the limitations of the study was the lack of consensus as to which fractures should be treated non-operatively. Thus, there is a possible variation between different hospitals in the way PHF is treated conservatively, creating different populations. Another limitation is the 19.5% of patients lost during the follow-up even though the sample size was calculated considering a 25% rate of dropouts. That means that the power of the study could be maintained even with a higher number of patients lost. A third limitation could be that secondary displacement of the fractures was not assessed, but the design of the study was done to detect outcome and complication differences considering that if no differences were found, the secondary displacement can be disregarded. In conclusion, in patients having a conservatively treated displaced or non-displaced proximal humeral fracture, there is no need to perform serial radiological assessment at the 1-week follow-up because the outcomes and complications will not be affected. Moreover, no change of treatment regimen is expected by having a one-week X-Ray control exam. Declarations Author Contribution All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by [CT], [I P-A], [E C], [L V], [R M], [M S], [F S], and [JM]. The first draft of the manuscript was written by [CT] and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. Acknowledgement The authors wish to thank Xavier Duran Jordà, MStat, PhD (Methodology and Biostatistics Support Unit, Institute Hospital del Mar for Medical Research (IMIM), Barcelona, Spain) for his work in data analysis. References Lanting B, MacDermid J, Drosdowech D, Faber KJ. (2008) Proximal humeral fractures: A systematic review of treatment modalities. J Shoulder Elbow Surg. 17:42-54. https://doi.org/10.1016/j.jse.2007.03.016. McLean AS, Price N, Graves S, Hatton A, Taylor FJ. (2019) Nationwide trends in management of proximal humeral fractures: an analysis of 77,966 cases from 2008 to 2017. J Shoulder Elbow Surg. 28:2072-8. https://doi.org/10.1016/j.jse.2019.03.034. Floyd SB, Campbell J, Chapman CG, Thigpen CA, Kissenberth MJ, Brooks JM. (2019) Geographic variation in the treatment of proximal humeraus fractures: an update on surgery rates and treatment consensus. J Orthop Surg Res. 14(1):22. https://doi.org/10.1186/S13018-018-1052-2. Soler-Peiro M, García-Martínez L, Aguilella L, Pérez-Barmejo M. (2020) Conservative treatment of 3-part and 4-part proximal humeral fractures: a systematic review. J Orthop Surg Res. 15:347. https://doi.org/10.1186/s13018-020-01880-7. Okike K, Lee OC, Makanji H, Harris MB, Vrahas MS. (2013) Factors associated with the decision for operative versus non-operative treatment of displaced proximal humerus fractures in the elderly. Injury. 44:448-55. https://doi.org/10.1016/j.injury.2012.09.002. 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Lopiz Y, Alcobía-Díaz B, Galán-Olleros M, García-Fernández C, López Picado A, Marco F. (2019) Reverse shoulder arthroplasty versus nonoperative treatment for 3- or 4-part proximal humeral fractures in elderly patients: a prospective randomized controlled trial. J Shoulder Elbow Surg. 28:2259-71. https://doi.org/10.1016/j.jse.2019.06.024 Hohmann E, Keough N, Glatt V, Tetsworth K. (2023) Surgical treatment is not superior to nonoperative treatment for displaced proximal humerus fractures: a systematic review and meta-analysis. J Shoulder Elbow Surg. 32:1105-20. https://doi.org/10.1016/j.jse.2023.01.002. Floyd SB, Thigpen C, Kissenberth M, Brooks JM. (2020) Association of surgical treatment with adverse events and mortality among medicare beneficiaries with proximal humerus fracture. JAMA Network Open. 3:e1918663. https://doi.org/10.1001/jamanetworkopen.2019.18663. Rangan A, Handoll H, Brealey S, Jefferson S, Keding A, Corbacho Martín B, Goodchild L, Chuang LH, Hewit C, Torgerson D, PROFHER Trial Collaborators. (2015) Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus the PROFHER randomized clinical trial. JAMA. 313:1037-47. https://doi.org/10.1001/jama.2015.1629. Handoll HHG, Elliott J, Thillemann TM, Aluko P, Brorson S. (2022) Interventions for treating proximal humeral fractures in adults. Cochrane Database of Systematic Reviews. 6:CD000434. https://doi.org/ 10.1002/14651858.CD000434.pub5 Martínez-Catalan N. (2023) Conservative treatment of proximal humerus fractures: when, how and what to expect. Curr Rev Musculoskelet Med. 16:75–84. https://doi.org/10.1007/s12178-022-09817-9. Koval KJ, Gallagher MA, Marsicano JG, Cuomo F, McShinawy A, Zuckerman JD. (1997) Functional outcome after minimally displaced fractures of the proximal part of the humerus. J Bone Joint Surg. 79-A:203-7. https://doi.org/ 10.2106/00004623-199702000-00006 Torrens C, Corrales M, Vilà G, Santana F, Cáceres E. (2011) Functional and Quality-of-Life Results of Displaced and Nondisplaced Proximal Humeral Fractures Treated Conservatively. J Orthop Trauma. 25:581-7. https://doi.org/10.1097/BOT.0b013e318210ed2f. Jud L, Hoessly M, Spross C, Jost B, Jacxsens M. (2023) Impact of aberrant beam paths on antero-posterior shoulder radiographs in proximal humeral fractures. Arch Orthop Trauma Surg. 143:5085-93. https://doi.org/ 10.1007/s00402-023-04901-2. Tables Tables 1 and 2 are available in the Supplementary Files section. Additional Declarations No competing interests reported. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6435848","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":453771053,"identity":"a7b8f095-4306-41ad-8416-245425b07379","order_by":0,"name":"Carlos Torrens","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAw0lEQVRIiWNgGAWjYDADfuKVskFpyQZ0EYJaDA4Qq4V/fvOxzxUVd+yNb7c/3fBzD4M8//wG/FokjrElzzxz5lnitjtnzG72PGMwnHGMgC0GbDzGjI1thxPMbuSw3eA5wJDAQJyWf4ftjWekP7v5B6hFnjgtDYcZN0gkmN0G2WJASIvEsbRkxoZjhxNnAP1yW+aAhOHGYwn4tfA3Hz7M2FBz2J5/dvuzm28O2MjLHT5AwBqEfUgkSVpGwSgYBaNgFGACABw6Q77/yZSjAAAAAElFTkSuQmCC","orcid":"","institution":"Hospital Del Mar","correspondingAuthor":true,"prefix":"","firstName":"Carlos","middleName":"","lastName":"Torrens","suffix":""},{"id":453771054,"identity":"87092d17-c171-495f-896d-59354961e387","order_by":1,"name":"Ivet Parés-Alfonso","email":"","orcid":"","institution":"Corporació Sanitària Parc Taulí","correspondingAuthor":false,"prefix":"","firstName":"Ivet","middleName":"","lastName":"Parés-Alfonso","suffix":""},{"id":453771055,"identity":"386d8fde-774a-438e-b695-e5d47dd98c31","order_by":2,"name":"Elisa Cassart","email":"","orcid":"","institution":"Hospital Universitari Germans Trias i Pujol","correspondingAuthor":false,"prefix":"","firstName":"Elisa","middleName":"","lastName":"Cassart","suffix":""},{"id":453771056,"identity":"3bdd11c8-1dec-44a7-8635-8eb301b570c1","order_by":3,"name":"Laura Valls","email":"","orcid":"","institution":"Althaia","correspondingAuthor":false,"prefix":"","firstName":"Laura","middleName":"","lastName":"Valls","suffix":""},{"id":453771057,"identity":"29148b22-462a-4a40-9c26-009f598b80e9","order_by":4,"name":"Raquel Martínez","email":"","orcid":"","institution":"Althaia","correspondingAuthor":false,"prefix":"","firstName":"Raquel","middleName":"","lastName":"Martínez","suffix":""},{"id":453771058,"identity":"f90fbe71-b9a9-488a-a85b-aad2b5495950","order_by":5,"name":"Monica Salomó","email":"","orcid":"","institution":"Corporació Sanitària Parc Taulí","correspondingAuthor":false,"prefix":"","firstName":"Monica","middleName":"","lastName":"Salomó","suffix":""},{"id":453771059,"identity":"d669d90a-9aa2-447f-bcd1-83811cace9f0","order_by":6,"name":"Fernando Santana","email":"","orcid":"","institution":"Hospital Del Mar","correspondingAuthor":false,"prefix":"","firstName":"Fernando","middleName":"","lastName":"Santana","suffix":""},{"id":453771060,"identity":"26276103-da1a-419b-b051-18620a9f62b2","order_by":7,"name":"Joan Miquel","email":"","orcid":"","institution":"Corporació Sanitària Parc Taulí","correspondingAuthor":false,"prefix":"","firstName":"Joan","middleName":"","lastName":"Miquel","suffix":""}],"badges":[],"createdAt":"2025-04-12 17:23:08","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6435848/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6435848/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":82561692,"identity":"6f1a3b9e-e09f-45d2-a384-d1a48ba835ac","added_by":"auto","created_at":"2025-05-13 01:39:55","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":34791,"visible":true,"origin":"","legend":"\u003cp\u003eConsolidated Standards of Reporting Trials (CONSORT) flow diagram outlining patient recruitment, allocation, and follow-up.\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6435848/v1/78d4c766ec85307a0fd693cf.jpg"},{"id":85466497,"identity":"fb817025-ea8b-4ee0-a5c1-f189d4968e3d","added_by":"auto","created_at":"2025-06-26 08:32:06","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":397931,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6435848/v1/77abb0a9-aa07-4441-852b-23494459f727.pdf"},{"id":82561693,"identity":"0d2805dc-37ea-44ef-a65b-2c34a8cc8515","added_by":"auto","created_at":"2025-05-13 01:39:55","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":26480,"visible":true,"origin":"","legend":"","description":"","filename":"Table1and2.docx","url":"https://assets-eu.researchsquare.com/files/rs-6435848/v1/62988effe60dd54f07da9d22.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"One-week X-ray control in acute proximal humeral fractures conservatively treated. Prospective randomized multicentric study.","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eProximal humeral fractures (PHF) are still a source of debate due to the lack of consensus on the best treatment for each case. The same fracture pattern can be treated conservatively or surgically depending on the surgeon's criteria [1\u0026ndash;7]. There is a lack of consensus of the 2 treatments perform. Furthermore, there is no consensus around the immobilization time required if conservative treatment is decided upon. Furthermore, a determination of the periodicity of imaging controls to perform until fracture consolidation is achieved is not clear [8,9]. A recent study analyses the need or not to conduct periodic imaging studies on conservatively treated non-displaced fractures of the proximal humerus. The study authors concluded that periodic imaging studies are unnecessary in 77% of the cases [9]. However, what has not been studied is whether periodic imaging studies should be conducted or their periodicity when treating displaced fractures of the proximal humerus conservatively. Hypothetically, there is always a greater risk of secondary displacement in these cases. The factors that predispose to secondary displacement of these fractures (such as alcohol abuse or osteoporosis) have been analyzed. However, no analysis was done of how this displacement may affect the outcome of the fracture, or whether it conditions a change in treatment [10].\u003c/p\u003e \u003cp\u003eThe main concern when treating a displaced proximal humeral fracture conservatively is that further displacement may happen within the first days. Additionally, that displacement may condition a change in the treatment, usually meaning a change to a surgical treatment. Knowing whether periodic imaging studies are needed or not needed in these patients might reduce the number of complementary explorations done as well as the number of check-ups necessary. That would be relevant given the high incidence rate of this type of fracture and the prospect of that rate increasing in the coming years [11,12].\u003c/p\u003e \u003cp\u003eThe main objective of this study was to determine whether it is necessary to perform a control X-ray study one week after the initial fracture, particularly when a displaced proximal humeral fracture has been treated conservatively, to detect possible secondary displacements that may result due to a change in the treatment.\u003c/p\u003e"},{"header":"MATERIAL AND METHODS","content":"\u003cp\u003eStudy Design\u003c/p\u003e \u003cp\u003eA prospective randomized multicenter study was designed to evaluate whether an X-ray assessment after one week of the fracture was needed for the conservatively treated PFH.\u003c/p\u003e \u003cp\u003eThis study involved 4 different centers. Enrollment began in February 2021 and ended in November 2021.\u003c/p\u003e \u003cp\u003eAfter opening a sealed opaque envelope containing the group number obtained from a computer-generated randomization list, the patients were allocated to either group I (with one-week X-Ray assessment) or group II (without X-ray assessment). The type of randomization was simple randomization. All included patients were followed for 1 year. Participants were enrolled during the first check-up, at 1 week after the fracture, after assessment of the inclusion and exclusion criteria.\u003c/p\u003e \u003cp\u003eInclusion and exclusion criteria\u003c/p\u003e \u003cp\u003eThe inclusion criteria were patients over 18 and below 85 years old, acute PHF, conservative treatment agreement, and the absence of a previous pathology of the affected shoulder.\u003c/p\u003e \u003cp\u003eThe exclusion criteria were cognitive deterioration and medical injuries that made it impossible to carry out a proper rehabilitation program as well as patient unwillingness to participate in the study.\u003c/p\u003e \u003cp\u003eThe decision to perform a surgical or conservative treatment was made after considering age, functional demand, and the fracture pattern. It was determined in accordance with the criteria of each shoulder surgeon from the different participating institutions. The fracture pattern was assessed by means of the initial X-ray study (including the anteroposterior and outlet view) and after the analysis of a computed tomography (CT) scan obtained on the same day as the initial X-ray.\u003c/p\u003e \u003cp\u003eTreatment Regimen\u003c/p\u003e \u003cp\u003eAll the patients from both groups were immobilized for three weeks with a sling bandage with restriction of arm rotation. Regardless of the group to which the patients were assigned, they were instructed to do passive elbow movements 5 times a day from the first day after the fracture. After the immobilization period of three weeks, all the patients followed the same progressive rehabilitation program, which included both self-assisted exercises at home and supervised exercises in a rehabilitation center.\u003c/p\u003e \u003cp\u003eOutcomes\u003c/p\u003e \u003cp\u003eThe functional outcome was evaluated at 6- and 12-months follow-up using the Constant score expressed in absolute values [13]. To assess the functional disability of the shoulder, a self-reported shoulder-specific questionnaire, the Simple Shoulder Test (SST), was also used at the 6- and 12-month follow-ups.\u003c/p\u003e \u003cp\u003eThe pain was assessed using a Visual analogue scale (VAS) that was administered at 1 week after the fracture, at 3 weeks, and then at the 3, 6 and 12-month follow-ups.\u003c/p\u003e \u003cp\u003eRadiographs (anteroposterior and outlet views) were obtained at the 1-week follow-up for the patients in Group 1. After the one-week visit, radiographs were obtained for both groups at the 3-, 6- and 12-month follow-ups.\u003c/p\u003e \u003cp\u003eAll the PHFs included were classified following the Neer classification system [14]. Given the known low reproducibility and concordance of the Neer classification system, fractures were classified based on a consensus reached among the shoulder surgeons in each center after reviewing the radiographs and the CT scans.\u003c/p\u003e \u003cp\u003eComplications including stiffness, non-union, osteonecrosis and the need for a subsequent surgery were also recorded for both groups. Those complications were also recorded for patients in group II that, for whatever reason, required a one-week X-ray exam.\u003c/p\u003e \u003cp\u003eAll the clinical assessments were done by an independent observer blinded to the group in which the patient was allocated.\u003c/p\u003e \u003cp\u003e All the included patients signed informed consent forms to participate in this study. This study was approved by the Parc de Salut Mar Ethical Committee (2021/9694/I) and registered at ClinicalTrials.gov (NCT04651543).\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eWith a sample size calculation accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 45 subjects in the first group and 45 in the second group were required to detect a difference equal to or greater than 10 units on Constant's Functional scale. The common standard deviation was assumed to be approximately 15 units. A loss to follow-up rate of 20% was estimated.\u003c/p\u003e \u003cp\u003ePreviously to the statistical analysis, changes were calculated for each variable (12 months \u0026ndash; 6 months). Continuous variables, including the calculated differences, were described as mean and standard deviations. Qualitative variables were described with frequency tables (number and percentage). Between group differences were assessed with the Student t-test for continuous variables and the Chi-square or Fisher exact test, as appropriate, for categorical variables. Statistical analyses were performed using STATA 15.1. The results were considered statistically significant at p-value\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cp\u003eIn the period from February 2021 to November 2021, 145 patient-candidates were included. Two of them were excluded due to severe dementia, leaving a total of 143 patients to be included. After randomization, 73 patients were assigned to group I and got the radiological assessment at one-week. The remaining 70 were assigned to group II and did not get the radiological assessment. There were 2 patients who died during the follow-up period, and 21 patients were lost during the follow-up for unknown reasons. That left 120 patients for the final analysis (Fig. 1).\u003c/p\u003e\n\u003cp\u003eThe mean age of the 143 patients included was 69.01 years (range, 19 to 94 years). There were 114 women and 29 men. The left arm was affected in 62 cases and the right arm in 81 cases. Most of the patients were right-handed, 124 vs. 19 cases. In the Neer classification system, there were 52 one-part fractures, 58 two-part fractures, 32 three-part fractures and 1 four-part fracture. The two groups were comparable in terms of age, gender, laterality, hand dominance, and fracture classification distribution, without significant differences between them (Table 1).\u003c/p\u003e\n\u003cp\u003eNo significant differences between the two groups were found in terms of functional outcomes as measured with the Constant score at 6 months (63.68 group I vs 64.22 group II, p = 0.871), and at 12-months (70.74 group I vs 70.82 group II, p = 0.982). Moreover, there were no differences in the Constant subscale scores (pain, daily living activities, forward elevation, abduction, lateral rotation, internal rotation, and strength) between the groups (Table 2).\u003c/p\u003e\n\u003cp\u003eNo statistically significant differences were noted between the two groups in terms of pain as measured with the VAS at 1 week (6.04group I vs 6.09 group II, p = 0.914), 3 weeks (4.49 group I vs 4.07 group II, p = 0.351), 3 months (2.69 group I vs 2.16 group II, p = 0.229), 6 months (2.11 group I vs 1.7 group II p = 0.353), and 12 months (1.47 group I vs 1.36 group II, p = 0.559) (Table 2).\u003c/p\u003e\n\u003cp\u003eNo significant differences between the two groups were found in the scores on the SST questionnaire items at 6 months (p = 0.864) and 12 months (p = 0.319) (Table II). Moreover, no significant differences were found between the two groups relative to complications (p =0.945). There were 8 complications (5.6%) reported during the follow-up period. Of those, there were 4 cases of stiffness (2 in group I and 2 in group II), 2 cases of avascular necrosis and stiffness in group I, 1 avascular necrosis in group I, and 1 non-union in group II.\u003c/p\u003e\n\u003cp\u003eTwo patients required surgery; both were included in the group I with the one-week X-Ray assessment. One was due to avascular necrosis that was detected at the 10-month follow-up and required a reverse shoulder arthroplasty. The other one was due to stiffness over 8-months that followed by arthroscopic releases. No other patients in either group required further surgery or a change in the treatment regimen.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn one patient assigned to group II, a one-week X-ray was considered necessary and was subsequently ordered. However, it did not lead to any change in the treatment regimen. At the follow-up, the patient was not experiencing any complication. The patient was analyzed in group II as per intention to treat.\u0026nbsp;\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThe best treatment for PHF is yet undetermined and as controversial as is the need for radiological assessment and its frequency when a non-operative treatment is chosen [1\u0026ndash;9,15\u0026ndash;20]. The results of the present study suggest that there is no need to ask for a one-week X-ray exam to analyze potential fracture displacements in conservatively treated proximal humeral fractures. With that, no change in treatment regimen is expected, the complication rate will not change, and the functional and quality-of-life outcomes will not change either.\u003c/p\u003e \u003cp\u003eWhen treating proximal humeral fractures conservatively, one of the major concerns is that there may be further displacement. If that occurs, surgical treatment can be offered instead of conservative. This is quite often the main reason the early imaging exam is requested if conservative treatment is decided. It is done to detect further displacement of the fracture early enough to be able to address it surgically. However, surgery is seldom needed when proximal humeral fractures are conservatively treated [9,21,22]. Moreover, only two patients required surgery in the present study. That decision was taken at 8 and 10-months after the fractures due to stiffness and avascular necrosis, not because of further displacement of the fracture. In addition, different patterns of the same fracture can be observed when obtaining serial X-ray exams. It was not because of fracture displacement but because of aberrant beam paths [23]. For both reasons, the role of early imaging assessment of conservatively treated fractures is suspect.\u003c/p\u003e \u003cp\u003eA recent study investigated the need for secondary surgery to detect secondary displacement in 100 one-part PHF as well as the functional result [7]. One group underwent routine radiological assessment while the other did so only if persistent pain was present. They concluded from their results that serial radiological evaluation of patients with a one-part PHF was only needed in those cases with comminution as serial radiological evaluation did not identify more displacement and thereby change the indication of conservative management. Only 4 out of the 100 patients included needed operative treatment because of secondary displacement [9]. These results are consistent with those obtained in the present study where only 2 out of 119 patients required surgical treatment. In the present study, not only one-part fractures were analyzed but also 2-, 3- and 4-part fractures. This is validation that even displaced fractures can be followed without the need for serial imaging exam.\u003c/p\u003e \u003cp\u003eAttempts to define risk factors for secondary displacement have been made in several studies [9,10]. Age and gender do not seem to influence secondary displacement. Neither does the pattern of the fracture as defined by the Neer classification system seem to be predictive of secondary displacement. However, severe osteoarthritis, osteoporosis, alcohol abuse and the disruption of the medial hinge and or comminution are relevant when assessing secondary displacement. In the present study, secondary displacement of the fractures included was not assessed. It was thought that if secondary displacement was relevant enough, it would be reflected in the functional and/or quality of life outcomes. As it would be in the number and type of complications. It was presumed that if the displacement would not affect outcomes and complications, then it could be overlooked. The results of the present study failed to find differences in outcomes and complications between patients having a Week-1 X-ray control and those without the X-ray control, meaning that there are no clinical consequences if further displacement has happened. Moreover, a one-week X-ray was ordered in one patient of the group without X-ray control because of the fracture pattern, but there was no change made in the treatment regimen after the X-ray assessment. In addition, the patient did not present any complication at the 1-year follow-up.\u003c/p\u003e \u003cp\u003eFrequently, and only because it has traditionally been done that way, we subject our patients to some overtreatment. In conservatively treated Proximal humeral fractures, it has been demonstrated that the immobilization period can be reduced in a safe way. It can be done without compromising outcomes and complications, allowing patients to freely use their injured arm to not compromise patient independence. The present study demonstrates that there is no need to obtain a one-week X-ray control in conservatively treated Proximal humeral fractures since this does not influence outcomes or complications. By doing that, the patient does not have to have extra visits and they are saved greater X-ray radiation exposure. This may also have an impact on orthopedic and imaging departments, both organizationally and economically, because of the ever increasing number of PHF.\u003c/p\u003e \u003cp\u003eAmong the limitations of the study was the lack of consensus as to which fractures should be treated non-operatively. Thus, there is a possible variation between different hospitals in the way PHF is treated conservatively, creating different populations. Another limitation is the 19.5% of patients lost during the follow-up even though the sample size was calculated considering a 25% rate of dropouts. That means that the power of the study could be maintained even with a higher number of patients lost. A third limitation could be that secondary displacement of the fractures was not assessed, but the design of the study was done to detect outcome and complication differences considering that if no differences were found, the secondary displacement can be disregarded.\u003c/p\u003e \u003cp\u003eIn conclusion, in patients having a conservatively treated displaced or non-displaced proximal humeral fracture, there is no need to perform serial radiological assessment at the 1-week follow-up because the outcomes and complications will not be affected. Moreover, no change of treatment regimen is expected by having a one-week X-Ray control exam.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eAll authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by [CT], [I P-A], [E C], [L V], [R M], [M S], [F S], and [JM]. The first draft of the manuscript was written by [CT] and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eThe authors wish to thank Xavier Duran Jord\u0026agrave;, MStat, PhD (Methodology and Biostatistics Support Unit, Institute Hospital del Mar for Medical Research (IMIM), Barcelona, Spain) for his work in data analysis.\u003c/p\u003e"},{"header":"References","content":"\u003col start=\"1\" type=\"1\"\u003e\n\u003cli\u003eLanting B, MacDermid J, Drosdowech D, Faber KJ. (2008) Proximal humeral fractures: A systematic review of treatment modalities. J Shoulder Elbow Surg. 17:42-54. https://doi.org/10.1016/j.jse.2007.03.016.\u003c/li\u003e\n\u003cli\u003eMcLean AS, Price N, Graves S, Hatton A, Taylor FJ. (2019) Nationwide trends in management of proximal humeral fractures: an analysis of 77,966 cases from 2008 to 2017. J Shoulder Elbow Surg. 28:2072-8. https://doi.org/10.1016/j.jse.2019.03.034.\u003c/li\u003e\n\u003cli\u003eFloyd SB, Campbell J, Chapman CG, Thigpen CA, Kissenberth MJ, Brooks JM. (2019) Geographic variation in the treatment of proximal humeraus fractures: an update on surgery rates and treatment consensus. J Orthop Surg Res. 14(1):22. https://doi.org/10.1186/S13018-018-1052-2.\u003c/li\u003e\n\u003cli\u003eSoler-Peiro M, Garc\u0026iacute;a-Mart\u0026iacute;nez L, Aguilella L, P\u0026eacute;rez-Barmejo M. (2020) Conservative treatment of 3-part and 4-part proximal humeral fractures: a systematic review. J Orthop Surg Res. 15:347. https://doi.org/10.1186/s13018-020-01880-7.\u003c/li\u003e\n\u003cli\u003eOkike K, Lee OC, Makanji H, Harris MB, Vrahas MS. (2013) Factors associated with the decision for operative versus non-operative treatment of displaced proximal humerus fractures in the elderly. Injury. 44:448-55. https://doi.org/10.1016/j.injury.2012.09.002.\u003c/li\u003e\n\u003cli\u003eHageman M, Jayakumar P, King J, Guitton TG, Doornberg JN, Ring D, Science Variation Group. (2015) The factors influencing the decision making of operative treatment for proximal humeral fractures. J Shoulder elbow Surg. 24:e21-6. https://doi.org/ 10.1016/j.jse.2014.05.013\u003c/li\u003e\n\u003cli\u003eLaMartina J, Christmas KN, Simon P, Streit JJ, Allert JW, Clark J, Otto RJ, Abdelfattah A, Mighell MA, Frankle MA. (2018) Difficulty in decision making in the treatment of displaced proximal humerus fractures: the effect of uncertainty on surgical outcomes. J Shoulder elbow Surg. 27:470-7. https://doi.org/ 10.1016/j.jse.2017.09.033\u003c/li\u003e\n\u003cli\u003eMart\u0026iacute;nez R, Santana F, Pardo A, Torrens C. (2021) One versus 3-week immobilization period for nonoperatively treated proximal humeral fractures. J Bone Joint Surg. 103:1491-8. https://doi.org/10.2106/JBJS.20.02137.\u003c/li\u003e\n\u003cli\u003eJacxsens M, Schmid J, Zdravkovic V, Jost B, Spross C. (2019) Is serial radiological evaluation of one-part proximal humeral fractures necessary? Bone Joint J. 101-B:1307-1312. https://doi.org/ 10.1302/0301-620X.101B10.BJJ-2019-0349.R1.\u003c/li\u003e\n\u003cli\u003eFrank F, Niehaus R, Borbas P, Eid K. Risk factors for secondary displacement in conservatively treated proximal humeral fractures. (2020) Bone Joint J. 102-B:881-9. https://doi.org/ 10.1302/0301-620X.102B7. BJJ-2020-0045.R1\u003c/li\u003e\n\u003cli\u003ePalvanen M, Kannus P, Niemi S, Parkkari J. (2006) Update in the epidemiology of proximal humeral fractures. Clinical Orthopaedics and Related Research. 442:87-92. https://doi.org/10.1097/01.blo.0000194672.79634.78.\u003c/li\u003e\n\u003cli\u003eLeino OK, Lehtim\u0026auml;ki KK, M\u0026auml;kel\u0026auml; K, \u0026Auml;\u0026auml;rimaa V, Ekman E. (2022) Proximal humeral fractures in Finland. Bone Joint J. 104-B:150-6. https://doi.org/ 10.1302/0301-620X.104B1.BJJ-2021-0987.R1\u003c/li\u003e\n\u003cli\u003eConstant CR, Murley A. (1987) A Clinical Method of Functional Assessment of the Shoulder. Clin Orthop Relat Res. 214:160-4.\u003c/li\u003e\n\u003cli\u003eNeer C.S 2\u003csup\u003end\u003c/sup\u003e. (1970) Displaced Proximal Humeral Fractures: Part I. Classification and Evaluation. J Bone Joint Surg Am. 52:1077-89.\u003c/li\u003e\n\u003cli\u003eLopiz Y, Alcob\u0026iacute;a-D\u0026iacute;az B, Gal\u0026aacute;n-Olleros M, Garc\u0026iacute;a-Fern\u0026aacute;ndez C, L\u0026oacute;pez Picado A, Marco F. (2019) Reverse shoulder arthroplasty versus nonoperative treatment for 3- or 4-part proximal humeral fractures in elderly patients: a prospective randomized controlled trial. J Shoulder Elbow Surg. 28:2259-71. https://doi.org/10.1016/j.jse.2019.06.024\u003c/li\u003e\n\u003cli\u003eHohmann E, Keough N, Glatt V, Tetsworth K. (2023) Surgical treatment is not superior to nonoperative treatment for displaced proximal humerus fractures: a systematic review and meta-analysis. J Shoulder Elbow Surg. 32:1105-20. https://doi.org/10.1016/j.jse.2023.01.002.\u003c/li\u003e\n\u003cli\u003eFloyd SB, Thigpen C, Kissenberth M, Brooks JM. (2020) Association of surgical treatment with adverse events and mortality among medicare beneficiaries with proximal humerus fracture. JAMA Network Open. 3:e1918663. https://doi.org/10.1001/jamanetworkopen.2019.18663.\u003c/li\u003e\n\u003cli\u003eRangan A, Handoll H, Brealey S, Jefferson S, Keding A, Corbacho Mart\u0026iacute;n B, Goodchild L, Chuang LH, Hewit C, Torgerson D, PROFHER Trial Collaborators. (2015) Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus the PROFHER randomized clinical trial. JAMA. 313:1037-47. https://doi.org/10.1001/jama.2015.1629.\u003c/li\u003e\n\u003cli\u003eHandoll HHG, Elliott J, Thillemann TM, Aluko P, Brorson S. (2022) Interventions for treating proximal humeral fractures in adults. Cochrane Database of Systematic Reviews. 6:CD000434. https://doi.org/ 10.1002/14651858.CD000434.pub5\u003c/li\u003e\n\u003cli\u003eMart\u0026iacute;nez-Catalan N. (2023) Conservative treatment of proximal humerus fractures: when, how and what to expect. Curr Rev Musculoskelet Med. 16:75\u0026ndash;84. https://doi.org/10.1007/s12178-022-09817-9.\u003c/li\u003e\n\u003cli\u003eKoval KJ, Gallagher MA, Marsicano JG, Cuomo F, McShinawy A, Zuckerman JD. (1997) Functional outcome after minimally displaced fractures of the proximal part of the humerus. J Bone Joint Surg. 79-A:203-7. https://doi.org/ 10.2106/00004623-199702000-00006\u003c/li\u003e\n\u003cli\u003eTorrens C, Corrales M, Vil\u0026agrave; G, Santana F, C\u0026aacute;ceres E. (2011) Functional and Quality-of-Life Results of Displaced and Nondisplaced Proximal Humeral Fractures Treated Conservatively. J Orthop Trauma. 25:581-7. https://doi.org/10.1097/BOT.0b013e318210ed2f.\u003c/li\u003e\n\u003cli\u003eJud L, Hoessly M, Spross C, Jost B, Jacxsens M. (2023) Impact of aberrant beam paths on antero-posterior shoulder radiographs in proximal humeral fractures. Arch Orthop Trauma Surg. 143:5085-93. https://doi.org/ 10.1007/s00402-023-04901-2.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 and 2 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Proximal humeral fracture, conservative treatment, non-operative, imaging, X-Ray control","lastPublishedDoi":"10.21203/rs.3.rs-6435848/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6435848/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003ePurpose\u003c/b\u003e\u003c/p\u003e \u003cp\u003eConservatively treated proximal humeral fractures (PHF) are often re-evaluated via X-ray after one-week to detect further displacements of the fracture that may require surgery. The objective of this study was to evaluate the need for a one-week X-ray evaluation of the conservatively treated PHF.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods\u003c/b\u003e\u003c/p\u003e \u003cp\u003eProspective randomized multicentric study involving 4 centers that included the conservatively treated PHF. Patients were randomized to group I (one-week X-Ray assessment) and to group II (without X-ray assessment). Pain was assessed with the VAS at weeks 1 and 3 and at 3, 6,12 months. The Constant Score and Simple Shoulder Test were recorded at 6- and 12-months. Complications were also recorded at any point.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e \u003cp\u003eA total of 143 patients were included. The mean age of the patients included was 69.01 years. There were 114 women and 29 men. There were 52 one-part, 58 two-part, 32 three-part and 1 four-part fracture. Group 1 consisted of 73 patients and 70 were allocated to group II. There were no significant differences between the two groups in terms of age, gender, dominance, and type of fracture. No statistically significant differences were noted between the 2 groups relative to the VAS at 1 week (p\u0026thinsp;=\u0026thinsp;0.914), 3 weeks (p\u0026thinsp;=\u0026thinsp;0.351), 3- (p\u0026thinsp;=\u0026thinsp;0.229), 6- (p\u0026thinsp;=\u0026thinsp;0.353), 12- month (p\u0026thinsp;=\u0026thinsp;0.559). Neither were there any differences in the Constant Score at 6- (63.68 vs 64.22, p\u0026thinsp;=\u0026thinsp;0.871), and 12-month (70.74 vs 70.82, p\u0026thinsp;=\u0026thinsp;0.982) or the SST at 6 (p\u0026thinsp;=\u0026thinsp;0.864) and 12-month (p\u0026thinsp;=\u0026thinsp;0.319). Two patients in group I required further surgery. There were 8 complications (6 in group I, 4 in group II) (p\u0026thinsp;=\u0026thinsp;0.945).\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusions\u003c/b\u003e\u003c/p\u003e \u003cp\u003eBased on the results of this study, a one-week control X-Ray is not necessary in conservatively treated PHF.\u003c/p\u003e","manuscriptTitle":"One-week X-ray control in acute proximal humeral fractures conservatively treated. 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