TY - JOUR
T1 - Surgical Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients
T2 - A Randomized Clinical Trial
AU - Lawson, Andrew
AU - Naylor, Justine M.
AU - Buchbinder, Rachelle
AU - Ivers, Rebecca
AU - Balogh, Zsolt J.
AU - Smith, Paul
AU - Xuan, Wei
AU - Howard, Kirsten
AU - Vafa, Arezoo
AU - Perriman, Diana
AU - Mittal, Rajat
AU - Yates, Piers
AU - Rieger, Bertram
AU - Smith, Geoff
AU - Adie, Sam
AU - Elkinson, Ilia
AU - Kim, Woosung
AU - Sungaran, Jai
AU - Latendresse, Kim
AU - Wong, James
AU - Viswanathan, Sameer
AU - Landale, Keith
AU - Drobetz, Herwig
AU - Tran, Phong
AU - Page, Richard
AU - Beattie, Sally
AU - Mulford, Jonathan
AU - Incoll, Ian
AU - Kale, Michael
AU - Schick, Bernard
AU - Li, Trent
AU - Higgs, Andrew
AU - Oppy, Andrew
AU - Harris, Ian A.
N1 - Funding Information:
Funding/Support: This study was funded by
Funding Information:
project grant APP1098550 from the National Health and Medical Research Council (NHMRC) and project funding from the Australian Orthopaedic Association Research Foundation, AO Trauma Asia Pacific, and the Lincoln Foundation. Dr Buchbinder is supported by an NHMRC Senior Principal Research Fellowship.
Publisher Copyright:
© 2021 American Medical Association. All rights reserved.
PY - 2021/3
Y1 - 2021/3
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85099713461&partnerID=8YFLogxK
U2 - 10.1001/jamasurg.2020.5672
DO - 10.1001/jamasurg.2020.5672
M3 - Article
C2 - 33439250
AN - SCOPUS:85099713461
SN - 2168-6254
VL - 156
SP - 229
EP - 237
JO - JAMA Surgery
JF - JAMA Surgery
IS - 3
ER -