Surgical Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients

医学 观察研究 随机对照试验 手腕 随机化 外科 内固定 生活质量(医疗保健) 患者满意度 物理疗法 最小临床重要差异 内科学 护理部
作者
Andrew B. Lawson,Justine Naylor,Rachelle Buchbinder,Rebecca Ivers,Zsolt J. Balogh,Paul N. Smith,Wei Xuan,Kirsten Howard,Arezoo Vafa,Diana M. Perriman,Rajat Mittal,Piers Yates,Bertram Rieger,Geoffrey C.S. Smith,Sam Adie,Ilia Elkinson,Woo‐Sung Kim,Jai Sungaran,Kim Latendresse,James Wong,Sameer Viswanathan,Keith Landale,Herwig Drobetz,Phong Tran,Richard S. Page,Sally Beattie,Jonathan Mulford,Ian Incoll,Michael Kale,Bernard Schick,Trent Li,Andrew Higgs,Andrew Oppy,Ian A. Harris
出处
期刊:JAMA Surgery [American Medical Association]
卷期号:156 (3): 229-229 被引量:57
标识
DOI:10.1001/jamasurg.2020.5672
摘要

The burden of injury and costs of wrist fractures are substantial. Surgical treatment became popular without strong supporting evidence.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.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.Surgical treatment was open reduction and internal fixation using a volar-locking plate (VLP). Nonsurgical treatment was closed reduction and cast immobilization (CR).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.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).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.http://anzctr.org.au identifier: ACTRN12616000969460.
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