학술논문
Surgical Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients: A Randomized Clinical Trial
Document Type
Article
Author
Lawson, Andrew; Naylor, Justine M.; Buchbinder, Rachelle; Ivers, Rebecca; Balogh, Zsolt J.; Smith, Paul; Xuan, Wei; Howard, Kirsten; Vafa, Arezoo; Perriman, Diana; Mittal, Rajat; Yates, Piers; Rieger, Bertram; Smith, Geoff; Adie, Sam; Elkinson, Ilia; Kim, Woosung; Sungaran, Jai; Latendresse, Kim; Wong, James; Viswanathan, Sameer; Landale, Keith; Drobetz, Herwig; Tran, Phong; Page, Richard; Beattie, Sally; Mulford, Jonathan; Incoll, Ian; Kale, Michael; Schick, Bernard; Li, Trent; Higgs, Andrew; Oppy, Andrew; Harris, Ian A.
Source
JAMA Surgery; March 2021, Vol. 156 Issue: 3 p229-237, 9p
Subject
Language
ISSN
21686254; 21686262
Abstract
IMPORTANCE: The burden of injury and costs of wrist fractures are substantial. Surgical treatment became popular without strong supporting evidence. OBJECTIVE: To assess whether current surgical treatment for displaced distal radius fractures provided better patient-reported wrist pain and function than nonsurgical treatment in patients 60 years and older. DESIGN, SETTING, AND PARTICIPANTS: In this multicenter randomized clinical trial and parallel observational study, 300 eligible patients were screened from 19 centers in Australia and New Zealand from December 1, 2016, until December 31, 2018. A total of 166 participants were randomized to surgical or nonsurgical treatment and followed up at 3 and 12 months by blinded assessors. Those 134 individuals who declined randomization were included in a parallel observational cohort with the same treatment options and follow-up. The primary analysis was intention to treat; sensitivity analyses included as-treated and per-protocol analyses. INTERVENTION: Surgical treatment was open reduction and internal fixation using a volar-locking plate (VLP). Nonsurgical treatment was closed reduction and cast immobilization (CR). MAIN OUTCOMES AND MEASURES: The primary outcome was the Patient-Rated Wrist Evaluation score at 12 months. Secondary outcomes were Disabilities of Arm, Shoulder, and Hand questionnaire score, health-related quality of life, pain, major complications, patient-reported treatment success, bother with appearance, and therapy use. RESULTS: In the 300 study participants (mean [SD] age, 71.2 [7.5] years; 269 [90%] female; 166 [81 VLP and 85 CR] in the randomized clinical trial sample and 134 [32 VLP and 102 CR] in the observational sample), no clinically important between-group difference in 12-month Patient-Rated Wrist Evaluation scores (mean [SD] score of 19.8 [21.1] for VLP and 21.5 [24.3] for CR; mean difference, 1.7 points; 95% CI −5.4 to 8.8) was observed. No clinically important differences were found in quality of life, wrist pain, or bother at 3 and 12 months. No significant difference was found in total complications between groups (12 of 84 [14%] for the CR group vs 6 of 80 [8%] for the VLP group; risk ratio [RR], 0.53; 95% CI, 0.21-1.33). Patient-reported treatment success favored the VLP group at 12 months (very successful or successful: 70 [89%] vs 57 [70%]; RR, 1.26; 95% CI, 1.07-1.48; P = .005). There was greater use of postoperative physical therapy in the VLP group (56 [72%] vs 44 [54%]; RR, 1.32; 95% CI, 1.04-1.69; P = 0.02). CONCLUSIONS AND RELEVANCE: This randomized clinical trial found no between-group differences in improvement in wrist pain or function at 12 months from VLP fixation over CR for displaced distal radius fractures in older people. TRIAL REGISTRATION: http://anzctr.org.au identifier: ACTRN12616000969460