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Does surgical treatment of wrist fractures with volar-locking plates in patients 60 years and older provide superior patient-reported wrist pain and function at 12 months after treatment compared with nonsurgical treatment?
In this randomized clinical trial and parallel observational study of 300 participants (166 who were randomized to surgical or nonsurgical treatment and 134 who declined randomization), no clinically important difference was found in wrist pain and function at 12 months in those who received surgical vs nonsurgical treatment.
In older patients, surgical treatment with volar-locking plates provided no important functional advantages over nonsurgical treatment at 12 months.
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.
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.
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.
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.
http://anzctr.org.au identifier: ACTRN12616000969460
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: October 5, 2020.
Published Online: January 13, 2021. doi:10.1001/jamasurg.2020.5672
Corresponding Author: Andrew Lawson, MPH, Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, 1 Campbell St, Liverpool, Sydney, New South Wales, Australia 2170 (email@example.com).
The CROSSFIRE Study Group Authors: Andrew Lawson, MPH; Justine M. Naylor, PhD; Rachelle Buchbinder, PhD; Rebecca Ivers, PhD; Zsolt J. Balogh, PhD; Paul Smith, BMBSS; Wei Xuan, PhD; Kirsten Howard, PhD; Arezoo Vafa, MIntTrdeLaw; Diana Perriman, PhD; Rajat Mittal, PhD; Piers Yates, MBBS; Bertram Rieger, MD; Geoff Smith, MBChB; Sam Adie, PhD; Ilia Elkinson, MBChB; Woosung Kim, MBChB; Jai Sungaran, MBBS; Kim Latendresse, MD; James Wong, MBBS; Sameer Viswanathan, MBBS; Keith Landale, MBBS; Herwig Drobetz, PhD; Phong Tran, MBBS; Richard Page, MBBS; Sally Beattie, RN; Jonathan Mulford, MBBS; Ian Incoll, MBBS; Michael Kale, MBBS; Bernard Schick, MBBS; Trent Li, MPH; Andrew Higgs, MBBS; Andrew Oppy, MBBS; Ian A. Harris, PhD.
Affiliations of The CROSSFIRE Study Group Authors: Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, Sydney, Australia (Lawson, Naylor, Vafa, Harris); South Western Sydney Clinical School, University of New South Wales, Sydney, Australia (Lawson, Naylor, Mittal, Harris); Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia (Buchbinder); Monash Department of Clinical Epidemiology, Cabrini Institute, Melbourne, Australia (Buchbinder); School of Population Health, University of New South Wales, Sydney, Australia (Ivers); John Hunter Hospital, Newcastle, Australia (Balogh); University of Newcastle, Newcastle, Australia (Balogh, Incoll); Canberra Hospital, Canberra, Australia (P. Smith, Perriman); Ingham Institute for Applied Medical Research, Sydney, Australia (Xuan); School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, Australia (Howard); Fiona Stanley Hospital, Perth, Australia (Yates, Rieger); St George and Sutherland Hospitals, Sydney, Australia (G. Smith, Adie); St George and Sutherland Clinical School, University of New South Wales, Sydney, Australia (Adie); Wellington Hospital, Wellington, New Zealand (Elkinson, Kim); Concord Hospital, Sydney, Australia (Sungaran); Nambour General Hospital, Nambour, Australia (Latendresse); Sunshine Coast University Hospital, Nambour, Australia (Latendresse); Westmead Hospital, Sydney, Australia (Wong); Campbelltown Hospital, Sydney, Australia (Viswanathan, Landale); Mackay Base Hospital, Mackay, Australia (Drobetz); Western Health, Melbourne, Australia (Tran); University Hospital Geelong, Barwon Health, Geelong, Australia (Page); Barwon Centre for Orthopaedic Research and Education, School of Medicine, Deakin University, Geelong, Australia (Page, Beattie); Launceston Hospital, Launceston, Australia (Mulford); Gosford and Wyong Hospitals, Gosford, Australia (Incoll, Kale); Prince of Wales Hospital, Sydney, Australia (Schick, Li); St Vincent’s Hospital, Sydney, Australia (Higgs); Royal Melbourne Hospital, Melbourne, Australia (Oppy); Liverpool Hospital, Sydney, Australia (Harris).
Author Contributions: Mr Lawson and Dr Harris had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Lawson, Naylor, Buchbinder, Ivers, Balogh, P. Smith, Vafa, Mittal, Rieger, G. Smith, Wong, Drobetz, Tran, Page, Kale, Oppy, Harris.
Acquisition, analysis, or interpretation of data: Lawson, Naylor, Buchbinder, Ivers, Balogh, P. Smith, Xuan, Howard, Vafa, Perriman, Mittal, Yates, Rieger, G. Smith, Adie, Elkinson, Kim, Sungaran, Latendresse, Wong, Viswanathan, Landale, Drobetz, Tran, Page, Beattie, Mulford, Incoll, Kale, Schick, Li, Higgs, Oppy, Harris.
Drafting of the manuscript: Lawson, Naylor, Buchbinder, Ivers, Vafa, Mittal, G. Smith, Kim, Wong, Tran, Mulford, Kale, Harris.
Critical revision of the manuscript for important intellectual content: Lawson, Naylor, Buchbinder, Ivers, Balogh, P. Smith, Xuan, Howard, Perriman, Mittal, Yates, Rieger, G. Smith, Adie, Elkinson, Sungaran, Latendresse, Viswanathan, Landale, Drobetz, Tran, Page, Beattie, Incoll, Kale, Schick, Li, Higgs, Oppy, Harris.
Statistical analysis: Lawson, Xuan, Harris.
Obtained funding: Naylor, Buchbinder, Ivers, Balogh, P. Smith, Harris.
Administrative, technical, or material support: Lawson, P. Smith, Vafa, Perriman, Mittal, Yates, Rieger, G. Smith, Adie, Elkinson, Kim, Sungaran, Latendresse, Landale, Drobetz, Tran, Page, Beattie, Mulford, Incoll, Kale, Li, Oppy, Harris.
Supervision: Naylor, P. Smith, G. Smith, Adie, Sungaran, Latendresse, Wong, Viswanathan, Tran, Page, Mulford, Incoll, Schick, Higgs, Oppy, Harris.
Other—QOL analysis: Howard.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was funded by 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.
Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 4.
Additional Contributions: Tim Churches, MBBS, provided advice on designing data collection, Shirley Cross assisted with participant follow-up, and Joseph Descallar, MBiostat, assisted in masking of treatment allocation. We thank the staff of the Ingham Institute for Applied Medical Research and the practitioners at the participating sites who contributed to site preparation and recruited trial participants: Marcus Simonian, Lin Qi, Jonathan Davies, Pushkar Khire, Thiruverni Ananthanathan, Paul Zotov, Rodney Archie (Mackay Hospital, Mackay, Queensland, Australia), Stuart Ferguson, Mina Fam, Janan Chandrananth, Harry Constantin, Taimoor Sehgol, Andrew Xiu, Stephen Butler, Daniel Cohen (Liverpool Hospital, Sydney, Australia), Maged Abdeen, Luke Barr, Dawei Huang, Nathan Underwood, May Soo, Aung Lynn, Liang Xu, Xuan Ye, Danielle Piper (Canberra Hospital, Canberra, Australia), Rui Lui, Scott Campbell, Chris Mulligan, Rodney Richmond, Mathew Morgan, Mitchell Kingston, Mitchell Steele, Nicholas Papadopoulos, Omar Mograby, Geff Keighley, Laura Harris, Michael Le (St George and Sutherland Hospitals, Sydney, Australia), Anton Lambers, Fahd Bangash, Joseph Henry, Ben Levy, Anthony Nguyen, Robert Evans, Craig Brownlie, Madeleine Jolly, Florian Schmid, Anthony Ng, Kieran Bochat, Ellie Houghton (Fiona Stanley Hospital, Perth, Australia), Sunho Kim, Nikos Fountas, Sol Han, Abhinav Agrawal (Concord Hospital, Sydney, Australia), Ken Ye, Tau Loseli, Gobind Bal and Dean Morris (Campbelltown Hospital, Sydney, Australia), James Drummond, Adrian Talia, Shun Hayasaka, Alexander Rahil, Andy Ho (Western Health, Melbourne, Australia), Hugh Gillies, Nicola Luppino, Brett Moreira, Andrew Wilkinson, David Owen, Jason Hocking (Barwon Health/Geelong Hospital, Victoria, Australia), David Ma, Damien Horton (Prince of Wales Hospital, Sydney, Australia), Rachel Price, Daniel Lemanu, Douglas Hancock, Teng Zhang, Kuhan Padmanathan, Seasol Shin (Wellington Hospital, Wellington, New Zealand), Alexander Mitrichev, Chris Ewing (Sunshine Coast University Hospital, Queensland, Australia), Rebecca Tang, Ben Prentice, John (Hao Nan) Du (Launceston Hospital, Launceston, Australia), Hussain Al-Ramadani (St Vincents Hospital, Sydney, Australia), Andrew Fraval (Royal Melbourne Hospital, Melbourne, Australia), Cyrus Mehrta, Jon Liew (Westmead Hospital, Sydney, Australia), and Anthony Boshell (John Hunter Hospital, Newcastle, Australia).
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