Does Clinical Improvement Translate to Satisfaction? Decisional Regret One Year After Balloon Kyphoplasty for Osteoporotic Vertebral Fractures in 187 Patients

Does Clinical Improvement Translate to Satisfaction? 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Decisional Regret One Year After Balloon Kyphoplasty for Osteoporotic Vertebral Fractures in 187 Patients Abhishek Soni, Madhava Pai Kanhangad, Vidyadhara Srinivasa, Balamurugan Thirugnanam, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6577946/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 : This study evaluates decisional regret one year after balloon kyphoplasty for osteoporotic vertebral compression fractures and its association with clinical outcomes. Methods : In this single-center retrospective study, 187 patients (mean age 77.60 ± 11.56 years, 58.8% female) who underwent balloon kyphoplasty between January 2022 and December 2022 were assessed. Outcomes included Oswestry Disability Index (ODI), Visual Analog Scale (VAS), kyphotic angle, and Decision Regret Scale (DRS) scores at one-year follow-up. Statistical analyses included paired t-tests, Pearson correlations, and chi-square tests. Results : Most patients (79.1%) reported no/mild regret (DRS 0–25), 20.9% had moderate regret (DRS 26–65), and none had high regret. Significant improvements were observed in ODI (40.14 ± 12.19 points), VAS (4.26 ± 2.23 points), and kyphotic angle (12.98 ± 3.98°; all p .05). Cement leakage occurred in 3.7% of cases without clinical symptoms. Conclusion : Balloon kyphoplasty is associated with low decisional regret, supporting its role as a well-accepted treatment. Comprehensive preoperative counseling is essential to optimize patient satisfaction. Kyphoplasty Patient Satisfaction Spinal Fractures Follow-Up Studies Bone Cements Figures Figure 1 Introduction Vertebral compression fractures (VCFs) affect approximately 1.4 million individuals annually worldwide [ 1 , 2 ], with 750,000 cases in the United States alone, leading to substantial morbidity and annual medical costs ranging from $ 12 billion to $ 18 billion in 2002 [ 2 , 3 ]. These fractures primarily affect the elderly, with 25% of postmenopausal women experiencing at least one VCF during their lifetime, a prevalence that increases with age, reaching 40% by age 80 [ 4 ]. Balloon kyphoplasty has become an established minimally invasive treatment for osteoporotic VCFs, aiming to alleviate pain, restore vertebral height, and correct kyphotic deformity. Studies have demonstrated its efficacy in pain reduction and functional improvement, with Visual Analog Scale (VAS) scores improving from preoperative levels of approximately 7.55 to 1.95 postoperatively, and Oswestry Disability Index (ODI) scores showing similar improvements [ 5 ]. When compared to vertebroplasty, kyphoplasty offers advantages in vertebral height restoration and kyphotic angle correction, with lower cement leakage rates [ 6 , 7 ]. Despite established clinical benefits, patient satisfaction and decisional regret following kyphoplasty remain underexplored. Decisional regret, defined as "distress or remorse after a health care decision," provides insight into the quality of the decision-making process and can be measured using the validated Decision Regret Scale (DRS) [ 8 ]. In spine surgery for degenerative conditions or spinal deformity, approximately 20% of patients report regret [ 9 , 10 ], but data specific to kyphoplasty for VCFs are limited. Understanding decisional regret after kyphoplasty is particularly important given the procedure's elective nature and the vulnerable population it serves. This study aims to evaluate the prevalence and severity of decisional regret in patients undergoing balloon kyphoplasty for osteoporotic vertebral compression fractures at one-year follow-up, and to identify factors associated with higher levels of regret. By addressing this gap in the literature, we hope to enhance the decision-making process and optimize patient-centered care for individuals with VCFs. Methods Hypothesis We hypothesized that clinical improvements following balloon kyphoplasty for osteoporotic vertebral compression fractures would be associated with lower decisional regret scores at one-year follow-up. The alternative hypothesis was that there would be no association between clinical outcomes and decisional regret. Study Design and Ethical Approval This single-center, retrospective study evaluated decisional regret in patients who underwent balloon kyphoplasty for osteoporotic vertebral compression fractures. The study protocol was approved by the Institutional Ethics Committee (ECR/34/Inst/KA/2013/RR-19). All participants provided informed consent for participation and use of their clinical data. The study was conducted in accordance with the STROBE guidelines for observational studies. Patient Selection We included consecutive adult patients (≥ 18 years) who underwent balloon kyphoplasty for osteoporotic vertebral compression fractures between January 1, 2022, and December 31, 2022. A power analysis determined that 187 patients would provide 80% power to detect moderate correlations (r = 0.25) between clinical improvements and decisional regret scores at a significance level of 0.05. Inclusion criteria were: (1) age ≥ 18 years, (2) diagnosis of osteoporotic vertebral compression fracture, (3) treatment with balloon kyphoplasty, (4) minimum follow-up of one year, and (5) ability to complete outcome assessments. Patients with pathological fractures, psychiatric illness, cognitive impairment, or those lost to follow-up were excluded. Data Collection and Outcome Measures Demographic and clinical data were extracted from electronic medical records, including age, sex, fracture characteristics, comorbidities, and preoperative measures. All patients completed the Oswestry Disability Index (ODI) for functional disability assessment [ 11 ] and Visual Analog Scale (VAS) for pain evaluation [ 12 ] both preoperatively and at one-year follow-up. Radiographic assessment included vertebral height and kyphotic angle measurements. The primary outcome was decisional regret measured by the Decision Regret Scale (DRS) at one-year follow-up. The DRS is a validated five-item questionnaire with scores ranging from 0–100, where higher scores indicate greater regret [ 8 ]. The DRS consists of five items scored from 1 to 5, yielding a raw score of 5 to 25, which is then normalized to a 0–100 scale by subtracting 5 and multiplying by 5, as per Brehaut et al. (2003) [ 8 ]. Based on established thresholds, regret was categorized as no/mild (0–25), moderate (26–65), and high (66–100) (Brehaut et al., 2003) [ 8 ]. Statistical Analysis Statistical analysis was performed using IBM SPSS Statistics (Version 28.0). Descriptive statistics included means, standard deviations, frequencies, and percentages. Paired t-tests assessed preoperative versus postoperative changes in clinical measures. Independent t-tests compared continuous variables between regret categories, and chi-square tests analyzed associations between categorical variables. We calculated Pearson correlation coefficients to evaluate relationships between DRS scores and clinical improvement measures. The minimal clinically important difference (MCID) was defined as 15 points for ODI, 2 points for VAS, and 5 degrees for kyphotic angle. A p-value < .05 was considered statistically significant. Assumptions for parametric tests were verified, and the homogeneity of variance was assessed for all comparative analyses. Results Patient Demographics and Characteristics Between January 1, 2022, and December 31, 2022, a total of 200 patients underwent balloon kyphoplasty for osteoporotic vertebral compression fractures at our institution. Of these, 187 patients (93.5%) completed the one-year follow-up assessment and were included in the final analysis. The mean age was 77.60 ± 11.56 years (range: 58–98 years), with a predominance of female patients (110 patients, 58.8%) compared to males (77 patients, 41.2%) (Table 1 ). Hypertension was the most common comorbidity (161 patients, 86.1%), followed by type 2 diabetes mellitus (95 patients, 50.8%). The most frequently treated vertebral levels were L1 (20.2%), T12 (18.4%), and L2 (13.7%), reflecting the typical distribution of osteoporotic vertebral compression fractures around the thoracolumbar junction. Cement leakage was detected in only 7 patients (3.7%), with no associated clinical symptoms (Table 1 ). Table 1 Demographic and clinical characteristics of patients undergoing balloon kyphoplasty for osteoporotic vertebral compression fractures, comparing those with no/mild regret (DRS score 0–25) to those with moderate regret (DRS score 26–65). Values presented as mean ± standard deviation or number (percentage). DRS = Decision Regret Scale; COPD = Chronic Obstructive Pulmonary Disease. Characteristic Total (n = 187) No/Mild Regret (n = 148) Moderate Regret (n = 39) p-value Age (years) 77.60 ± 11.56 77.53 ± 11.62 77.87 ± 11.65 0.87 Gender 0.26 Female 110 (58.8%) 84 (56.8%) 26 (66.7%) Male 77 (41.2%) 64 (43.2%) 13 (33.3%) Common Comorbidities Hypertension 161 (86.1%) 127 (85.8%) 34 (87.2%) - Type 2 Diabetes Mellitus 95 (50.8%) 74 (50.0%) 21 (53.8%) - Ischemic Heart Disease 27 (14.4%) 22 (14.9%) 5 (12.8%) - COPD 11 (5.9%) 9 (6.1%) 2 (5.1%) - Chronic Kidney Disease 9 (4.8%) 7 (4.7%) 2 (5.1%) - Cement Leakage 7 (3.7%) 6 (4.1%) 1 (2.6%) 0.66 DRS Score 20.94 ± 9.17 15.25 ± 6.63 41.79 ± 8.46 < 0.001 Clinical Outcomes All clinical outcome measures demonstrated statistically significant improvements at one-year follow-up compared to preoperative values (Fig. 1 & Table 2 ). The mean ODI score improved from 70.22 ± 8.28 preoperatively to 30.08 ± 8.96 postoperatively, representing a mean improvement of 40.14 ± 12.19 points (p < .001) or a 56.55% reduction in disability. This improvement substantially exceeded the established MCID of 15 points. Pain scores measured by VAS showed significant reduction from a mean preoperative value of 8.58 ± 1.20 to 4.32 ± 1.71 at one-year follow-up, with a mean improvement of 4.26 ± 2.23 points (p < .001), representing a 48.07% reduction in pain intensity. This improvement was more than twice the established MCID of 2 points. Radiographic assessment revealed significant correction of kyphotic deformity, with the mean kyphotic angle improving from 17.32 ± 3.81° preoperatively to 4.34 ± 2.83° postoperatively, representing a mean correction of 12.98 ± 3.98° (p < .001), which exceeded the MCID of 5 degrees. Table 2 Comparison of pre-operative and post-operative clinical outcomes at one-year follow-up after balloon kyphoplasty (n = 187). Values presented as mean ± standard deviation. ODI = Oswestry Disability Index; VAS = Visual Analog Scale. Outcome Measure Pre-operative Post-operative Mean Improvement p-value ODI Score 70.22 ± 8.28 30.08 ± 8.96 40.14 ± 12.19 < 0.001 VAS Pain Score 8.58 ± 1.20 4.32 ± 1.71 4.26 ± 2.23 < 0.001 Kyphotic Angle (°) 17.32 ± 3.81 4.34 ± 2.83 12.98 ± 3.98 < 0.001 Decisional Regret The mean Decision Regret Scale (DRS) score at one-year follow-up was 20.94 ± 9.17 (range: 0–65). Based on established classifications, 148 patients (79.1%) reported no or mild regret (DRS score 0–25), 39 patients (20.9%) reported moderate regret (DRS score 26–65), and no patients reported high regret (DRS score 66–100). When comparing patients with no/mild regret to those with moderate regret (Table 3 ), no statistically significant differences were observed in terms of age (77.53 ± 11.62 vs. 77.87 ± 11.65 years, p = .87), gender distribution (56.8% vs. 66.7% female, p = .26), or the presence of cement leakage (4.1% vs. 2.6%, p = .66). Similarly, there were no significant differences between the regret categories in terms of clinical improvements. Patients with no/mild regret showed a mean ODI improvement of 39.75 ± 12.30 points compared to 41.62 ± 11.84 points in those with moderate regret (p = .79). VAS improvement was 4.30 ± 2.24 points in the no/mild regret group versus 4.08 ± 2.23 points in the moderate regret group (p = .57). Kyphotic angle correction was 12.81 ± 3.69° in patients with no/mild regret compared to 13.62 ± 4.96° in those with moderate regret (p = .52). Table 3 Comparison of clinical improvements between regret categories and correlation analysis of Decision Regret Scale (DRS) scores with clinical outcomes at one-year follow-up after balloon kyphoplasty. Values presented as mean ± standard deviation. ODI = Oswestry Disability Index; VAS = Visual Analog Scale. Outcome No/Mild Regret (n = 148) Moderate Regret (n = 39) p-value Correlation with DRS (r) p-value ODI Improvement 39.75 ± 12.30 41.62 ± 11.84 0.79 -0.0115 0.88 VAS Improvement 4.30 ± 2.24 4.08 ± 2.23 0.57 -0.0314 0.67 Kyphotic Angle Improvement (°) 12.81 ± 3.69 13.62 ± 4.96 0.52 - - Discussion This single-center retrospective study evaluated decisional regret in patients who underwent balloon kyphoplasty for osteoporotic vertebral compression fractures. Our findings demonstrate a predominantly low level of decisional regret one year after the procedure, with 79.1% of patients reporting no or mild regret. Clinical Outcomes and Procedural Success Our study demonstrated significant improvements in pain, functional status, and kyphotic deformity correction, consistent with previous literature on kyphoplasty outcomes. The mean improvement in ODI score of 40.14 points (56.55% reduction) and VAS score of 4.26 points (48.07% reduction) exceeded the established minimal clinically important differences. These findings align with those of Jose et al. (2024) and Isik and Çevik (2020), who reported substantial improvements in ODI and pain scores following kyphoplasty [ 5 , 13 ]. The significant correction of kyphotic deformity observed in our study (mean correction of 12.98°) is also comparable to previous reports. Jose et al. (2024) noted improvement in kyphotic angle from 14.3° to 7.5° [ 5 ], while our study showed more substantial correction from 17.32° to 4.34°, possibly reflecting differences in baseline deformity severity, surgical technique, or patient selection. This finding is consistent with Saxena et al. (2015), who reported effective vertebral height restoration and kyphotic deformity correction with balloon kyphoplasty [ 14 ]. The low cement leakage rate of 3.7% in our study is noteworthy compared to previous literature. Bula et al. (2010) noted cement leakage rates between 4–10% for kyphoplasty [ 15 ], which is still higher than our finding. This lower rate might be attributed to refined surgical technique and careful patient selection, representing a potential advantage of our approach. Importantly, none of the cement leakage cases in our study resulted in clinical symptoms, further supporting the safety profile of the procedure. Gu et al. (2016) also noted that kyphoplasty is associated with lower rates of cement leakage compared to vertebroplasty [ 7 ], which aligns with our results. Decisional Regret The most significant contribution of our study is the specific evaluation of decisional regret following kyphoplasty. While decisional regret has been studied in various surgical specialties, specific data on kyphoplasty are limited. Our finding that 79.1% of patients experienced no or mild regret adds valuable evidence that patients generally do not regret undergoing kyphoplasty for vertebral compression fractures. The absence of correlation between clinical improvement and decisional regret in our study is noteworthy. As noted by Chehade et al. (2024) [ 16 ], decisional regret involves factors beyond objective clinical outcomes, such as the decision-making process and treatment options, highlighting the complex interplay of factors that contribute to patient satisfaction following surgical interventions. Clinical Implications Our findings have several important clinical implications. First, the low prevalence of decisional regret supports balloon kyphoplasty as an acceptable treatment option for osteoporotic vertebral compression fractures. Second, the lack of correlation between clinical improvement and decisional regret highlights the importance of comprehensive preoperative counseling that addresses not only expected clinical outcomes but also patient expectations and concerns. As Ghinea (2023) proposed, a "regret-minimization framework" for informed consent that discusses potential future regrets might be valuable in this context [ 17 ]. Limitations and Future Directions Several limitations should be acknowledged. The retrospective design is susceptible to selection bias and relies on the accuracy of medical records. The single-center nature limits generalizability, and the telephone-based assessment of decisional regret might have introduced recall bias. Additionally, we did not explore psychological factors such as depression or anxiety, which have been shown to influence decisional regret in other surgical populations, with preoperative depression associated with 4.0-fold increased odds of high decisional regret [ 9 ]. Future research should include prospective, multicenter studies with larger sample sizes to validate our findings. Longitudinal assessment of decisional regret at multiple time points would provide insight into how regret evolves over time, as the temporal dimension of regret experience remains underexplored [ 16 ]. Inclusion of psychological measures and qualitative exploration of factors contributing to regret would enhance our understanding of the patient experience. Furthermore, comparing decisional regret between different vertebral augmentation techniques (kyphoplasty, vertebroplasty, and vertebral implants) would be valuable, as Li et al. (2023) noted differences in clinical outcomes between these approaches [ 6 ]. Finally, development and evaluation of targeted preoperative counseling strategies aimed at minimizing decisional regret could improve patient care and satisfaction, a concept supported by Pope and Lessler's (2017) work on revolutionizing informed consent to empower patients [ 18 ]. Conclusion This study demonstrates that balloon kyphoplasty for osteoporotic vertebral compression fractures is associated with a notably low prevalence of decisional regret, with 79.1% of patients reporting no or mild regret at one-year follow-up. These findings suggest that patients generally perceive the decision to undergo this procedure favorably, reflecting high satisfaction with the treatment choice. Significant improvements in pain, functional status, and kyphotic deformity correction were observed, alongside a low cement leakage rate of 3.7% without clinical sequelae, underscoring the procedure's efficacy and safety. The low decisional regret supports balloon kyphoplasty as a well-accepted treatment option. Future prospective, multicenter studies are needed to further validate these findings and explore factors influencing patient satisfaction over time. Declarations Funding: No funding was received to assist with the preparation of this manuscript. Competing Interests: The authors have no relevant financial or non-financial interests to disclose. Ethics Approval: The study was approved by the institutional ethics committee and complies with the current laws of the country, where it was performed. Consent: All participants provided informed consent for participation and use of their clinical data. Author Contribution Author Contributions:- Conceptualization: VS- Methodology: HP, AS- Formal Analysis: AS, BT- Data Curation: AS, BT- Investigation: VS, MPK, BT- Writing – Original Draft: AS, HP- Writing – Review & Editing: VS, MPK, HP- Supervision: VS- Project Administration: VS- All authors read and approved the final manuscript. References Ranade M, Geeraert R, Pandit H. Vertebroplasty: For whom and when. Maturitas [Internet]. 2018 Dec [cited 2025 Apr 6];118:76–7. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0378512218304134 Weinstein JN. Balancing Science and Informed Choice in Decisions about Vertebroplasty. N Engl J Med [Internet]. 2009 Aug 6 [cited 2025 Apr 6];361(6):619–21. Available from: http://www.nejm.org/doi/abs/10.1056/NEJMe0905889 Charipova K, Kaye AD, Gress K. Vertebral Compression Fractures. In: Viswanath O, Urits I, editors. Cambridge Handbook of Pain Medicine [Internet]. 1st ed. Cambridge University Press; 2023 [cited 2025 Apr 6]. p. 107–18. 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Ann Med Res [Internet]. 2020 [cited 2025 Apr 6];27(2):738. Available from: https://ejmanager.com/fulltextpdf.php?mno=78842 Saxena BP, Shah BV, Joshi SP. Outcome of percutaneous balloon kyphoplasty in vertebral compression fractures. Indian J Orthop [Internet]. 2015 Aug [cited 2025 Apr 6];49(4):458–64. Available from: https://link.springer.com/10.4103/0019-5413.159673 Bula P, Lein T, Straßberger C, Bonnaire F. Ballonkyphoplastie zur Behandlung osteoporotischer Wirbelfrakturen: Indikationen – Behandlungsstrategie – Komplikationen. Z Für Orthop Unfallchirurgie [Internet]. 2010 Nov 15 [cited 2025 Apr 6];148(06):646–56. Available from: http://www.thieme-connect.de/DOI/DOI?10.1055/s-0030-1250379 Mireille Chehade, Margaret M Mccarthy, Allison Squires. Patient-related decisional regret: An evolutionary concept analysis. J Clin Nurs. 2024; Ghinea N. ‘First ensure no regret’: a decision-theoretic approach to informed consent in clinical practice. J Med Ethics [Internet]. 2023 May 8 [cited 2025 Apr 6];jme-2023-109087. Available from: https://jme.bmj.com/lookup/doi/10.1136/jme-2023-109087 Pope TM, Lessler D. Revolutionizing Informed Consent: Empowering Patients with Certified Decision Aids. Patient - Patient-Centered Outcomes Res [Internet]. 2017 Oct [cited 2025 Apr 6];10(5):537–9. Available from: http://link.springer.com/10.1007/s40271-017-0230-3 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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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-6577946","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":458511369,"identity":"084bd3c0-9194-44c3-9752-6cd52372eccc","order_by":0,"name":"Abhishek Soni","email":"","orcid":"","institution":"Manipal Hospital","correspondingAuthor":false,"prefix":"","firstName":"Abhishek","middleName":"","lastName":"Soni","suffix":""},{"id":458511370,"identity":"0a596d9c-13ef-48f2-ab23-c5c7f3e6e903","order_by":1,"name":"Madhava Pai Kanhangad","email":"","orcid":"","institution":"Kasturba Medical College, Manipal","correspondingAuthor":false,"prefix":"","firstName":"Madhava","middleName":"Pai","lastName":"Kanhangad","suffix":""},{"id":458511371,"identity":"68ce0596-d380-492e-b128-f8fbc860b273","order_by":2,"name":"Vidyadhara Srinivasa","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA3ElEQVRIiWNgGAWjYDACZgYDBgYDifp+ECehgGgtFTaMMxtAWgyIsweo7Ewa44YDUDZh9ceZt0n8bDvMbHx+deKHBwYM8vxiBwhoOcxWJtnbdpjN7MbbzRJAhxnOnJ2AX4tkM4+ZBG/bYR6zG2c3gLQkGNwmQovk37bDEsYzzm7+QZQWfmYeM2meM2kGBvy924izhZ+ZrdhapsImQeIG7zaLBAMJwn5h4z+88eYbA4kE/v6zm2/+qLCR55cmoAUIWCTAlARYpQRB5SDA/AHixANEqR4Fo2AUjIIRCAD01UGlsFmPXQAAAABJRU5ErkJggg==","orcid":"","institution":"Manipal Hospital","correspondingAuthor":true,"prefix":"","firstName":"Vidyadhara","middleName":"","lastName":"Srinivasa","suffix":""},{"id":458511372,"identity":"bdaa1be6-ccb3-4c62-ae0d-b28b99b7c9e7","order_by":3,"name":"Balamurugan Thirugnanam","email":"","orcid":"","institution":"Manipal Hospital","correspondingAuthor":false,"prefix":"","firstName":"Balamurugan","middleName":"","lastName":"Thirugnanam","suffix":""},{"id":458511373,"identity":"43e27c9c-8b89-4653-9f2a-834e02648624","order_by":4,"name":"Harshad Pawar","email":"","orcid":"","institution":"Manipal Hospital","correspondingAuthor":false,"prefix":"","firstName":"Harshad","middleName":"","lastName":"Pawar","suffix":""}],"badges":[],"createdAt":"2025-05-02 11:23:19","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6577946/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6577946/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":83198736,"identity":"4a5bf47e-a4b2-450d-b166-4140483006b9","added_by":"auto","created_at":"2025-05-21 06:05:40","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":123623,"visible":true,"origin":"","legend":"\u003cp\u003ePre-operative versus post-operative outcome measures at one-year follow-up following balloon kyphoplasty (n=187). All improvements were statistically significant (p \u0026lt; .001). Error bars represent standard deviation. ODI = Oswestry Disability Index; VAS = Visual Analog Scale.\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-6577946/v1/c5af8e5fcdfe9d2ec2699140.png"},{"id":88654043,"identity":"8d31be6e-0fef-410b-867e-c74925b1dc77","added_by":"auto","created_at":"2025-08-08 18:31:45","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":787012,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6577946/v1/6bde264f-7bef-4f23-b4eb-e95f7e8b39db.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Does Clinical Improvement Translate to Satisfaction? Decisional Regret One Year After Balloon Kyphoplasty for Osteoporotic Vertebral Fractures in 187 Patients","fulltext":[{"header":"Introduction","content":"\u003cp\u003eVertebral compression fractures (VCFs) affect approximately 1.4\u0026nbsp;million individuals annually worldwide [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e], with 750,000 cases in the United States alone, leading to substantial morbidity and annual medical costs ranging from \u003cspan\u003e$\u003c/span\u003e12\u0026nbsp;billion to \u003cspan\u003e$\u003c/span\u003e18\u0026nbsp;billion in 2002 [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. These fractures primarily affect the elderly, with 25% of postmenopausal women experiencing at least one VCF during their lifetime, a prevalence that increases with age, reaching 40% by age 80 [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eBalloon kyphoplasty has become an established minimally invasive treatment for osteoporotic VCFs, aiming to alleviate pain, restore vertebral height, and correct kyphotic deformity. Studies have demonstrated its efficacy in pain reduction and functional improvement, with Visual Analog Scale (VAS) scores improving from preoperative levels of approximately 7.55 to 1.95 postoperatively, and Oswestry Disability Index (ODI) scores showing similar improvements [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. When compared to vertebroplasty, kyphoplasty offers advantages in vertebral height restoration and kyphotic angle correction, with lower cement leakage rates [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDespite established clinical benefits, patient satisfaction and decisional regret following kyphoplasty remain underexplored. Decisional regret, defined as \"distress or remorse after a health care decision,\" provides insight into the quality of the decision-making process and can be measured using the validated Decision Regret Scale (DRS) [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. In spine surgery for degenerative conditions or spinal deformity, approximately 20% of patients report regret [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e], but data specific to kyphoplasty for VCFs are limited.\u003c/p\u003e \u003cp\u003eUnderstanding decisional regret after kyphoplasty is particularly important given the procedure's elective nature and the vulnerable population it serves. This study aims to evaluate the prevalence and severity of decisional regret in patients undergoing balloon kyphoplasty for osteoporotic vertebral compression fractures at one-year follow-up, and to identify factors associated with higher levels of regret. By addressing this gap in the literature, we hope to enhance the decision-making process and optimize patient-centered care for individuals with VCFs.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eHypothesis\u003c/h2\u003e \u003cp\u003eWe hypothesized that clinical improvements following balloon kyphoplasty for osteoporotic vertebral compression fractures would be associated with lower decisional regret scores at one-year follow-up. The alternative hypothesis was that there would be no association between clinical outcomes and decisional regret.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eStudy Design and Ethical Approval\u003c/h3\u003e\n\u003cp\u003eThis single-center, retrospective study evaluated decisional regret in patients who underwent balloon kyphoplasty for osteoporotic vertebral compression fractures. The study protocol was approved by the Institutional Ethics Committee (ECR/34/Inst/KA/2013/RR-19). All participants provided informed consent for participation and use of their clinical data. The study was conducted in accordance with the STROBE guidelines for observational studies.\u003c/p\u003e\n\u003ch3\u003ePatient Selection\u003c/h3\u003e\n\u003cp\u003eWe included consecutive adult patients (\u0026ge;\u0026thinsp;18 years) who underwent balloon kyphoplasty for osteoporotic vertebral compression fractures between January 1, 2022, and December 31, 2022. A power analysis determined that 187 patients would provide 80% power to detect moderate correlations (r\u0026thinsp;=\u0026thinsp;0.25) between clinical improvements and decisional regret scores at a significance level of 0.05.\u003c/p\u003e \u003cp\u003eInclusion criteria were: (1) age\u0026thinsp;\u0026ge;\u0026thinsp;18 years, (2) diagnosis of osteoporotic vertebral compression fracture, (3) treatment with balloon kyphoplasty, (4) minimum follow-up of one year, and (5) ability to complete outcome assessments. Patients with pathological fractures, psychiatric illness, cognitive impairment, or those lost to follow-up were excluded.\u003c/p\u003e\n\u003ch3\u003eData Collection and Outcome Measures\u003c/h3\u003e\n\u003cp\u003eDemographic and clinical data were extracted from electronic medical records, including age, sex, fracture characteristics, comorbidities, and preoperative measures. All patients completed the Oswestry Disability Index (ODI) for functional disability assessment [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] and Visual Analog Scale (VAS) for pain evaluation [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e] both preoperatively and at one-year follow-up. Radiographic assessment included vertebral height and kyphotic angle measurements.\u003c/p\u003e \u003cp\u003eThe primary outcome was decisional regret measured by the Decision Regret Scale (DRS) at one-year follow-up. The DRS is a validated five-item questionnaire with scores ranging from 0\u0026ndash;100, where higher scores indicate greater regret [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. The DRS consists of five items scored from 1 to 5, yielding a raw score of 5 to 25, which is then normalized to a 0\u0026ndash;100 scale by subtracting 5 and multiplying by 5, as per Brehaut et al. (2003) [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Based on established thresholds, regret was categorized as no/mild (0\u0026ndash;25), moderate (26\u0026ndash;65), and high (66\u0026ndash;100) (Brehaut et al., 2003) [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eStatistical analysis was performed using IBM SPSS Statistics (Version 28.0). Descriptive statistics included means, standard deviations, frequencies, and percentages. Paired t-tests assessed preoperative versus postoperative changes in clinical measures. Independent t-tests compared continuous variables between regret categories, and chi-square tests analyzed associations between categorical variables.\u003c/p\u003e \u003cp\u003eWe calculated Pearson correlation coefficients to evaluate relationships between DRS scores and clinical improvement measures. The minimal clinically important difference (MCID) was defined as 15 points for ODI, 2 points for VAS, and 5 degrees for kyphotic angle. A p-value\u0026thinsp;\u0026lt;\u0026thinsp;.05 was considered statistically significant. Assumptions for parametric tests were verified, and the homogeneity of variance was assessed for all comparative analyses.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003ePatient Demographics and Characteristics\u003c/h2\u003e \u003cp\u003eBetween January 1, 2022, and December 31, 2022, a total of 200 patients underwent balloon kyphoplasty for osteoporotic vertebral compression fractures at our institution. Of these, 187 patients (93.5%) completed the one-year follow-up assessment and were included in the final analysis. The mean age was 77.60\u0026thinsp;\u0026plusmn;\u0026thinsp;11.56 years (range: 58\u0026ndash;98 years), with a predominance of female patients (110 patients, 58.8%) compared to males (77 patients, 41.2%) (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eHypertension was the most common comorbidity (161 patients, 86.1%), followed by type 2 diabetes mellitus (95 patients, 50.8%). The most frequently treated vertebral levels were L1 (20.2%), T12 (18.4%), and L2 (13.7%), reflecting the typical distribution of osteoporotic vertebral compression fractures around the thoracolumbar junction. Cement leakage was detected in only 7 patients (3.7%), with no associated clinical symptoms (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDemographic and clinical characteristics of patients undergoing balloon kyphoplasty for osteoporotic vertebral compression fractures, comparing those with no/mild regret (DRS score 0\u0026ndash;25) to those with moderate regret (DRS score 26\u0026ndash;65). Values presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation or number (percentage). DRS\u0026thinsp;=\u0026thinsp;Decision Regret Scale; COPD\u0026thinsp;=\u0026thinsp;Chronic Obstructive Pulmonary Disease.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTotal (n\u0026thinsp;=\u0026thinsp;187)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNo/Mild Regret (n\u0026thinsp;=\u0026thinsp;148)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eModerate Regret (n\u0026thinsp;=\u0026thinsp;39)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77.60\u0026thinsp;\u0026plusmn;\u0026thinsp;11.56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e77.53\u0026thinsp;\u0026plusmn;\u0026thinsp;11.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e77.87\u0026thinsp;\u0026plusmn;\u0026thinsp;11.65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.87\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGender\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.26\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e110 (58.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e84 (56.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e26 (66.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77 (41.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e64 (43.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e13 (33.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCommon Comorbidities\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypertension\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e161 (86.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e127 (85.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e34 (87.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eType 2 Diabetes Mellitus\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95 (50.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e74 (50.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e21 (53.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIschemic Heart Disease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e27 (14.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22 (14.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5 (12.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCOPD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (5.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (6.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (5.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChronic Kidney Disease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (4.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (4.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (5.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCement Leakage\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (3.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (4.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (2.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.66\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDRS Score\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20.94\u0026thinsp;\u0026plusmn;\u0026thinsp;9.17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15.25\u0026thinsp;\u0026plusmn;\u0026thinsp;6.63\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e41.79\u0026thinsp;\u0026plusmn;\u0026thinsp;8.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eClinical Outcomes\u003c/h3\u003e\n\u003cp\u003eAll clinical outcome measures demonstrated statistically significant improvements at one-year follow-up compared to preoperative values (Fig.\u0026nbsp;1 \u0026amp; Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The mean ODI score improved from 70.22\u0026thinsp;\u0026plusmn;\u0026thinsp;8.28 preoperatively to 30.08\u0026thinsp;\u0026plusmn;\u0026thinsp;8.96 postoperatively, representing a mean improvement of 40.14\u0026thinsp;\u0026plusmn;\u0026thinsp;12.19 points (p\u0026thinsp;\u0026lt;\u0026thinsp;.001) or a 56.55% reduction in disability. This improvement substantially exceeded the established MCID of 15 points.\u003c/p\u003e \u003cp\u003ePain scores measured by VAS showed significant reduction from a mean preoperative value of 8.58\u0026thinsp;\u0026plusmn;\u0026thinsp;1.20 to 4.32\u0026thinsp;\u0026plusmn;\u0026thinsp;1.71 at one-year follow-up, with a mean improvement of 4.26\u0026thinsp;\u0026plusmn;\u0026thinsp;2.23 points (p\u0026thinsp;\u0026lt;\u0026thinsp;.001), representing a 48.07% reduction in pain intensity. This improvement was more than twice the established MCID of 2 points.\u003c/p\u003e \u003cp\u003eRadiographic assessment revealed significant correction of kyphotic deformity, with the mean kyphotic angle improving from 17.32\u0026thinsp;\u0026plusmn;\u0026thinsp;3.81\u0026deg; preoperatively to 4.34\u0026thinsp;\u0026plusmn;\u0026thinsp;2.83\u0026deg; postoperatively, representing a mean correction of 12.98\u0026thinsp;\u0026plusmn;\u0026thinsp;3.98\u0026deg; (p\u0026thinsp;\u0026lt;\u0026thinsp;.001), which exceeded the MCID of 5 degrees.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of pre-operative and post-operative clinical outcomes at one-year follow-up after balloon kyphoplasty (n\u0026thinsp;=\u0026thinsp;187). Values presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation. ODI\u0026thinsp;=\u0026thinsp;Oswestry Disability Index; VAS\u0026thinsp;=\u0026thinsp;Visual Analog Scale.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOutcome Measure\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePre-operative\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePost-operative\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMean Improvement\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eODI Score\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e70.22\u0026thinsp;\u0026plusmn;\u0026thinsp;8.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e30.08\u0026thinsp;\u0026plusmn;\u0026thinsp;8.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e \u003cp\u003e40.14\u0026thinsp;\u0026plusmn;\u0026thinsp;12.19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVAS Pain Score\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e8.58\u0026thinsp;\u0026plusmn;\u0026thinsp;1.20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e4.32\u0026thinsp;\u0026plusmn;\u0026thinsp;1.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e \u003cp\u003e4.26\u0026thinsp;\u0026plusmn;\u0026thinsp;2.23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eKyphotic Angle (\u0026deg;)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e17.32\u0026thinsp;\u0026plusmn;\u0026thinsp;3.81\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e4.34\u0026thinsp;\u0026plusmn;\u0026thinsp;2.83\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e \u003cp\u003e12.98\u0026thinsp;\u0026plusmn;\u0026thinsp;3.98\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eDecisional Regret\u003c/h2\u003e \u003cp\u003eThe mean Decision Regret Scale (DRS) score at one-year follow-up was 20.94\u0026thinsp;\u0026plusmn;\u0026thinsp;9.17 (range: 0\u0026ndash;65). Based on established classifications, 148 patients (79.1%) reported no or mild regret (DRS score 0\u0026ndash;25), 39 patients (20.9%) reported moderate regret (DRS score 26\u0026ndash;65), and no patients reported high regret (DRS score 66\u0026ndash;100).\u003c/p\u003e \u003cp\u003eWhen comparing patients with no/mild regret to those with moderate regret (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e), no statistically significant differences were observed in terms of age (77.53\u0026thinsp;\u0026plusmn;\u0026thinsp;11.62 vs. 77.87\u0026thinsp;\u0026plusmn;\u0026thinsp;11.65 years, p\u0026thinsp;=\u0026thinsp;.87), gender distribution (56.8% vs. 66.7% female, p\u0026thinsp;=\u0026thinsp;.26), or the presence of cement leakage (4.1% vs. 2.6%, p\u0026thinsp;=\u0026thinsp;.66).\u003c/p\u003e \u003cp\u003eSimilarly, there were no significant differences between the regret categories in terms of clinical improvements. Patients with no/mild regret showed a mean ODI improvement of 39.75\u0026thinsp;\u0026plusmn;\u0026thinsp;12.30 points compared to 41.62\u0026thinsp;\u0026plusmn;\u0026thinsp;11.84 points in those with moderate regret (p\u0026thinsp;=\u0026thinsp;.79). VAS improvement was 4.30\u0026thinsp;\u0026plusmn;\u0026thinsp;2.24 points in the no/mild regret group versus 4.08\u0026thinsp;\u0026plusmn;\u0026thinsp;2.23 points in the moderate regret group (p\u0026thinsp;=\u0026thinsp;.57). Kyphotic angle correction was 12.81\u0026thinsp;\u0026plusmn;\u0026thinsp;3.69\u0026deg; in patients with no/mild regret compared to 13.62\u0026thinsp;\u0026plusmn;\u0026thinsp;4.96\u0026deg; in those with moderate regret (p\u0026thinsp;=\u0026thinsp;.52).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of clinical improvements between regret categories and correlation analysis of Decision Regret Scale (DRS) scores with clinical outcomes at one-year follow-up after balloon kyphoplasty. Values presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation. ODI\u0026thinsp;=\u0026thinsp;Oswestry Disability Index; VAS\u0026thinsp;=\u0026thinsp;Visual Analog Scale.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOutcome\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo/Mild Regret (n\u0026thinsp;=\u0026thinsp;148)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eModerate Regret (n\u0026thinsp;=\u0026thinsp;39)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eCorrelation with DRS (r)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eODI Improvement\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e39.75\u0026thinsp;\u0026plusmn;\u0026thinsp;12.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e41.62\u0026thinsp;\u0026plusmn;\u0026thinsp;11.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-0.0115\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.88\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVAS Improvement\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e4.30\u0026thinsp;\u0026plusmn;\u0026thinsp;2.24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e4.08\u0026thinsp;\u0026plusmn;\u0026thinsp;2.23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-0.0314\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.67\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eKyphotic Angle Improvement (\u0026deg;)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e \u003cp\u003e12.81\u0026thinsp;\u0026plusmn;\u0026thinsp;3.69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e \u003cp\u003e13.62\u0026thinsp;\u0026plusmn;\u0026thinsp;4.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis single-center retrospective study evaluated decisional regret in patients who underwent balloon kyphoplasty for osteoporotic vertebral compression fractures. Our findings demonstrate a predominantly low level of decisional regret one year after the procedure, with 79.1% of patients reporting no or mild regret.\u003c/p\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eClinical Outcomes and Procedural Success\u003c/h2\u003e \u003cp\u003eOur study demonstrated significant improvements in pain, functional status, and kyphotic deformity correction, consistent with previous literature on kyphoplasty outcomes. The mean improvement in ODI score of 40.14 points (56.55% reduction) and VAS score of 4.26 points (48.07% reduction) exceeded the established minimal clinically important differences. These findings align with those of Jose et al. (2024) and Isik and \u0026Ccedil;evik (2020), who reported substantial improvements in ODI and pain scores following kyphoplasty [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe significant correction of kyphotic deformity observed in our study (mean correction of 12.98\u0026deg;) is also comparable to previous reports. Jose et al. (2024) noted improvement in kyphotic angle from 14.3\u0026deg; to 7.5\u0026deg; [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e], while our study showed more substantial correction from 17.32\u0026deg; to 4.34\u0026deg;, possibly reflecting differences in baseline deformity severity, surgical technique, or patient selection. This finding is consistent with Saxena et al. (2015), who reported effective vertebral height restoration and kyphotic deformity correction with balloon kyphoplasty [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe low cement leakage rate of 3.7% in our study is noteworthy compared to previous literature. Bula et al. (2010) noted cement leakage rates between 4\u0026ndash;10% for kyphoplasty [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e], which is still higher than our finding. This lower rate might be attributed to refined surgical technique and careful patient selection, representing a potential advantage of our approach. Importantly, none of the cement leakage cases in our study resulted in clinical symptoms, further supporting the safety profile of the procedure. Gu et al. (2016) also noted that kyphoplasty is associated with lower rates of cement leakage compared to vertebroplasty [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e], which aligns with our results.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eDecisional Regret\u003c/h2\u003e \u003cp\u003eThe most significant contribution of our study is the specific evaluation of decisional regret following kyphoplasty. While decisional regret has been studied in various surgical specialties, specific data on kyphoplasty are limited. Our finding that 79.1% of patients experienced no or mild regret adds valuable evidence that patients generally do not regret undergoing kyphoplasty for vertebral compression fractures.\u003c/p\u003e \u003cp\u003eThe absence of correlation between clinical improvement and decisional regret in our study is noteworthy. As noted by Chehade et al. (2024) [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e], decisional regret involves factors beyond objective clinical outcomes, such as the decision-making process and treatment options, highlighting the complex interplay of factors that contribute to patient satisfaction following surgical interventions.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eClinical Implications\u003c/h2\u003e \u003cp\u003eOur findings have several important clinical implications. First, the low prevalence of decisional regret supports balloon kyphoplasty as an acceptable treatment option for osteoporotic vertebral compression fractures. Second, the lack of correlation between clinical improvement and decisional regret highlights the importance of comprehensive preoperative counseling that addresses not only expected clinical outcomes but also patient expectations and concerns. As Ghinea (2023) proposed, a \"regret-minimization framework\" for informed consent that discusses potential future regrets might be valuable in this context [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eLimitations and Future Directions\u003c/h2\u003e \u003cp\u003eSeveral limitations should be acknowledged. The retrospective design is susceptible to selection bias and relies on the accuracy of medical records. The single-center nature limits generalizability, and the telephone-based assessment of decisional regret might have introduced recall bias. Additionally, we did not explore psychological factors such as depression or anxiety, which have been shown to influence decisional regret in other surgical populations, with preoperative depression associated with 4.0-fold increased odds of high decisional regret [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eFuture research should include prospective, multicenter studies with larger sample sizes to validate our findings. Longitudinal assessment of decisional regret at multiple time points would provide insight into how regret evolves over time, as the temporal dimension of regret experience remains underexplored [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Inclusion of psychological measures and qualitative exploration of factors contributing to regret would enhance our understanding of the patient experience.\u003c/p\u003e \u003cp\u003eFurthermore, comparing decisional regret between different vertebral augmentation techniques (kyphoplasty, vertebroplasty, and vertebral implants) would be valuable, as Li et al. (2023) noted differences in clinical outcomes between these approaches [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Finally, development and evaluation of targeted preoperative counseling strategies aimed at minimizing decisional regret could improve patient care and satisfaction, a concept supported by Pope and Lessler's (2017) work on revolutionizing informed consent to empower patients [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study demonstrates that balloon kyphoplasty for osteoporotic vertebral compression fractures is associated with a notably low prevalence of decisional regret, with 79.1% of patients reporting no or mild regret at one-year follow-up. These findings suggest that patients generally perceive the decision to undergo this procedure favorably, reflecting high satisfaction with the treatment choice. Significant improvements in pain, functional status, and kyphotic deformity correction were observed, alongside a low cement leakage rate of 3.7% without clinical sequelae, underscoring the procedure's efficacy and safety. The low decisional regret supports balloon kyphoplasty as a well-accepted treatment option. Future prospective, multicenter studies are needed to further validate these findings and explore factors influencing patient satisfaction over time.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eFunding:\u003c/h2\u003e\n\u003cp\u003eNo funding was received to assist with the preparation of this manuscript.\u003c/p\u003e\n\u003ch2\u003eCompeting Interests:\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003eThe authors have no relevant financial or non-financial interests to disclose.\u003c/p\u003e\n\u003ch2\u003eEthics Approval:\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003eThe study was approved by the institutional ethics committee and complies with the current laws of the country, where it was performed.\u003c/p\u003e\n\u003ch2\u003eConsent:\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003eAll participants provided informed consent for participation and use of their clinical data.\u003c/p\u003e\n\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\n\u003cp\u003eAuthor Contributions:- Conceptualization: VS- Methodology: HP, AS- Formal Analysis: AS, BT- Data Curation: AS, BT- Investigation: VS, MPK, BT- Writing \u0026ndash; Original Draft: AS, HP- Writing \u0026ndash; Review \u0026amp; Editing: VS, MPK, HP- Supervision: VS- Project Administration: VS- All authors read and approved the final manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eRanade M, Geeraert R, Pandit H. Vertebroplasty: For whom and when. Maturitas [Internet]. 2018 Dec [cited 2025 Apr 6];118:76\u0026ndash;7. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0378512218304134\u003c/li\u003e\n\u003cli\u003eWeinstein JN. Balancing Science and Informed Choice in Decisions about Vertebroplasty. N Engl J Med [Internet]. 2009 Aug 6 [cited 2025 Apr 6];361(6):619\u0026ndash;21. Available from: http://www.nejm.org/doi/abs/10.1056/NEJMe0905889\u003c/li\u003e\n\u003cli\u003eCharipova K, Kaye AD, Gress K. Vertebral Compression Fractures. In: Viswanath O, Urits I, editors. Cambridge Handbook of Pain Medicine [Internet]. 1st ed. Cambridge University Press; 2023 [cited 2025 Apr 6]. p. 107\u0026ndash;18. Available from: https://www.cambridge.org/core/product/identifier/9781108979849%23CN-bp-16/type/book_part\u003c/li\u003e\n\u003cli\u003eOld JL, Calvert M. Vertebral compression fractures in the elderly. Am Fam Physician. 2004 Jan 1;69(1):111\u0026ndash;6. \u003c/li\u003e\n\u003cli\u003eJose RS, Moosa MS, Bava NK. Functional and Radiological Outcome of Percutaneous Balloon Kyphoplasty for the Treatment of Osteoporotic Vertebral Compression Fractures \u0026ndash; A Prospective Study. J Orthop Dis Traumatol [Internet]. 2024 Jan [cited 2025 Apr 6];7(1):40\u0026ndash;6. Available from: https://journals.lww.com/10.4103/jodp.jodp_51_23\u003c/li\u003e\n\u003cli\u003eLi T, Pang S, England R, Gong A, Botros D, Manupipatpong S, Hui FK, Khan M. Clinical Outcomes and Safety Comparison of Vertebroplasty, Balloon Kyphoplasty, and Vertebral Implant for Treatment of Vertebral Compression Fractures. Am J Neuroradiol [Internet]. 2023 Nov [cited 2025 Apr 6];44(11):1345\u0026ndash;51. Available from: http://www.ajnr.org/lookup/doi/10.3174/ajnr.A8031\u003c/li\u003e\n\u003cli\u003eGu CN, Brinjikji W, Evans AJ, Murad MH, Kallmes DF. Outcomes of vertebroplasty compared with kyphoplasty: a systematic review and meta-analysis. J NeuroInterventional Surg [Internet]. 2016 Jun [cited 2025 Apr 6];8(6):636\u0026ndash;42. Available from: https://jnis.bmj.com/lookup/doi/10.1136/neurintsurg-2015-011714\u003c/li\u003e\n\u003cli\u003eBrehaut JC, O\u0026rsquo;Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a Decision Regret Scale. Med Decis Making [Internet]. 2003 Jul [cited 2025 Apr 6];23(4):281\u0026ndash;92. Available from: https://journals.sagepub.com/doi/10.1177/0272989X03256005\u003c/li\u003e\n\u003cli\u003eAdogwa O, Caruso JP, Eldridge CM, Singh R, Chilakapati S, Deme P, Stutzman SE, Aoun SG, Aanand D Naik, Bagley CA, Makris UE. Decisional Regret Among Older Adults Undergoing Corrective Surgery for Adult Spinal Deformity: A Single Institutional Study. Spine. 2021 Nov 22; \u003c/li\u003e\n\u003cli\u003eAna Wilson, Wilson A, Megan Winner, Winner M, Alexander T. Yahanda, Alexander Yahanda, Yahanda AT, Nikolaos Andreatos, Andreatos N, Sean Ronnekleiv-Kelly, Ronnekleiv-Kelly SM, Timothy M. Pawlik, Pawlik TM. Factors associated with decisional regret among patients undergoing major thoracic and abdominal operations. Surgery. 2017 Apr 1;161(4):1058\u0026ndash;66. \u003c/li\u003e\n\u003cli\u003eFairbank JCT, Pynsent PB. The Oswestry Disability Index: Spine [Internet]. 2000 Nov [cited 2025 Apr 6];25(22):2940\u0026ndash;53. Available from: http://journals.lww.com/00007632-200011150-00017\u003c/li\u003e\n\u003cli\u003eHawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short‐Form McGill Pain Questionnaire (SF‐MPQ), Chronic Pain Grade Scale (CPGS), Short Form‐36 Bodily Pain Scale (SF‐36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res [Internet]. 2011 Nov [cited 2025 Apr 6];63(S11). Available from: https://acrjournals.onlinelibrary.wiley.com/doi/10.1002/acr.20543\u003c/li\u003e\n\u003cli\u003eIsik S, Cevik S. Efficacy of balloon kyphoplasty in pain management of vertebral compression fractures. Ann Med Res [Internet]. 2020 [cited 2025 Apr 6];27(2):738. Available from: https://ejmanager.com/fulltextpdf.php?mno=78842\u003c/li\u003e\n\u003cli\u003eSaxena BP, Shah BV, Joshi SP. Outcome of percutaneous balloon kyphoplasty in vertebral compression fractures. Indian J Orthop [Internet]. 2015 Aug [cited 2025 Apr 6];49(4):458\u0026ndash;64. Available from: https://link.springer.com/10.4103/0019-5413.159673\u003c/li\u003e\n\u003cli\u003eBula P, Lein T, Stra\u0026szlig;berger C, Bonnaire F. Ballonkyphoplastie zur Behandlung osteoporotischer Wirbelfrakturen: Indikationen \u0026ndash; Behandlungsstrategie \u0026ndash; Komplikationen. Z F\u0026uuml;r Orthop Unfallchirurgie [Internet]. 2010 Nov 15 [cited 2025 Apr 6];148(06):646\u0026ndash;56. Available from: http://www.thieme-connect.de/DOI/DOI?10.1055/s-0030-1250379\u003c/li\u003e\n\u003cli\u003eMireille Chehade, Margaret M Mccarthy, Allison Squires. Patient-related decisional regret: An evolutionary concept analysis. J Clin Nurs. 2024; \u003c/li\u003e\n\u003cli\u003eGhinea N. \u0026lsquo;First ensure no regret\u0026rsquo;: a decision-theoretic approach to informed consent in clinical practice. J Med Ethics [Internet]. 2023 May 8 [cited 2025 Apr 6];jme-2023-109087. Available from: https://jme.bmj.com/lookup/doi/10.1136/jme-2023-109087\u003c/li\u003e\n\u003cli\u003ePope TM, Lessler D. Revolutionizing Informed Consent: Empowering Patients with Certified Decision Aids. Patient - Patient-Centered Outcomes Res [Internet]. 2017 Oct [cited 2025 Apr 6];10(5):537\u0026ndash;9. Available from: http://link.springer.com/10.1007/s40271-017-0230-3\u003c/li\u003e\n\u003c/ol\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":"Kyphoplasty, Patient Satisfaction, Spinal Fractures, Follow-Up Studies, Bone Cements","lastPublishedDoi":"10.21203/rs.3.rs-6577946/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6577946/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose\u003c/strong\u003e: This study evaluates decisional regret one year after balloon kyphoplasty for osteoporotic vertebral compression fractures and its association with clinical outcomes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: In this single-center retrospective study, 187 patients (mean age 77.60 ± 11.56 years, 58.8% female) who underwent balloon kyphoplasty between January 2022 and December 2022 were assessed. Outcomes included Oswestry Disability Index (ODI), Visual Analog Scale (VAS), kyphotic angle, and Decision Regret Scale (DRS) scores at one-year follow-up. Statistical analyses included paired t-tests, Pearson correlations, and chi-square tests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: Most patients (79.1%) reported no/mild regret (DRS 0–25), 20.9% had moderate regret (DRS 26–65), and none had high regret. Significant improvements were observed in ODI (40.14 ± 12.19 points), VAS (4.26 ± 2.23 points), and kyphotic angle (12.98 ± 3.98°; all p \u0026lt; .001). Clinical improvements showed no correlation with DRS scores (p \u0026gt; .05). Cement leakage occurred in 3.7% of cases without clinical symptoms.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e: Balloon kyphoplasty is associated with low decisional regret, supporting its role as a well-accepted treatment. Comprehensive preoperative counseling is essential to optimize patient satisfaction.\u003c/p\u003e","manuscriptTitle":"Does Clinical Improvement Translate to Satisfaction? Decisional Regret One Year After Balloon Kyphoplasty for Osteoporotic Vertebral Fractures in 187 Patients","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-21 06:05:35","doi":"10.21203/rs.3.rs-6577946/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","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}}],"origin":"","ownerIdentity":"61823cdb-2a85-4707-b321-57057426b107","owner":[],"postedDate":"May 21st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-08-08T18:23:36+00:00","versionOfRecord":[],"versionCreatedAt":"2025-05-21 06:05:35","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6577946","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6577946","identity":"rs-6577946","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}