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Published in: Trials 1/2020

Open Access 01-12-2020 | Distal Radius Fracture | Update

A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analysis plan

Authors: Andrew Lawson, Justine Naylor, Rachelle Buchbinder, Rebecca Ivers, Zsolt Balogh, Paul Smith, Rajat Mittal, Wei Xuan, Kirsten Howard, Arezoo Vafa, Piers Yates, Bertram Rieger, Geoff Smith, Ilia Elkinson, Woosung Kim, Jai Sungaran, Kim Latendresse, James Wong, Sameer Viswanathan, Keith Landale, Herwig Drobetz, Phong Tran, Richard Page, Raphael Hau, Jonathan Mulford, Ian Incoll, Michael Kale, Bernard Schick, Andrew Higgs, Andrew Oppy, Diana Perriman, Ian Harris

Published in: Trials | Issue 1/2020

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Abstract

Background

We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan.

Methods/design

A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance.

Discussion

This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients.

Trial registration

CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969​460).
This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution.
Appendix
Available only for authorised users
Literature
1.
2.
Ansari U, Adie S, Harris IA, et al. Practice variation in common fracture presentations: a survey of orthopaedic surgeons. Injury. 2011;42(4):403–7.PubMedCrossRef
3.
Mellstrand Navarro C, Brolund A, Ekholm C, Heintz E, Hoxha Ekström E, Josefsson PO, et al. Treatment of radius or ulna fractures in the elderly: a systematic review covering effectiveness, safety, economic aspects and current practice. PLoS One. 2019;14(3):p.1–28.
4.
Chan YH, et al. Comparison between cast immobilization versus volar locking plate fixation of distal radius fractures in active elderly patients, the Asian perspective. Hand Surg. 2014;19:19–23.PubMedCrossRef
5.
Arora R, et al. A prospective randomized trial comparing nonoperative treatment with volar locking plate fixation for displaced and unstable distal radial fractures in patients sixty-five years of age and older. J Bone Jt Surg (Am). 2011;93(23):2146–53.CrossRef
6.
Belloti JC, et al. Treatment of reducible unstable fractures of the distal radius in adults: a randomised controlled trial of De Palma percutaneous pinning versus bridging external fixation. BMC Musculoskelet Disord. 2010;11:137.PubMedPubMedCentralCrossRef
7.
8.
Egol K, et al. Bridging external fixation and supplementary Kirschner-wire fixation versus volar locked plating for unstable fractures of the distal radius: a randomised, prospective trial. J Bone Jt Surg (Br). 2008;90(9):1214–21.CrossRef
9.
Egol, K., et al., Bridging external fixation and supplementary Kirschner-wire fixation versus volar locked plating for unstable fractures of thedistal radius: a randomised, prospective trial. J Bone Jt Surg (Br), 2008. 90(9): 1214–21.
10.
Egol KA, et al. Distal radial fractures in the elderly: operative compared with nonoperative treatment. J Bone Jt Surg (Am). 2010;92A(9):1851–7.CrossRef
11.
Gradl G, et al. Non-bridging external fixation employing multiplanar K-wires versus volar locked plating for dorsally displaced fractures of the distal radius. Arch Orthop Traum Su. 2013;133(5):595–602.CrossRef
12.
Grewal R, et al. Open reduction internal fixation versus percutaneous pinning with external fixation of distal radius fractures: a prospective, randomized clinical trial. J Hand Surg [Am]. 2011;36(12):1899–906.CrossRef
13.
Harley BJ, et al. Augmented external fixation versus percutaneous pinning and casting for unstable fractures of the distal radius—a prospective randomized trial. J Hand Surg [Am]. 2004;29(5):815–24.CrossRef
14.
Kreder HJ, et al. A randomized, controlled trial of distal radius fractures with metaphyseal displacement but without joint incongruity: closed reduction and casting versus closed reduction, spanning external fixation, and optional percutaneous K-wires. J Orthop Trauma. 2006;20:115–21.PubMedCrossRef
15.
Margaloit Z, et al. A meta-analysis of outcomes of external fixation versus plate osteosynthesis for unstable distal radius fractures. J Hand Surg (Am). 2005;30(6):1185 e1–17.
16.
Young CF, Nanu AM, Checketts RG. Seven-year outcome following Colles’ type distal radial fracture. A comparison of two treatment methods. J Hand Surg (Br). 2003;28(5):422–6.CrossRef
17.
18.
Gamble C, Krishan A, Stocken D, et al. Guidelines for the content of statistical analysis plans in clinical trials. JAMA. 2017;318(23):2337–43.PubMedCrossRef
19.
20.
Grant AM, et al. Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial. BMJ. 2008;337:a2664.PubMedPubMedCentralCrossRef
21.
Blazeby JM, Barham CP, Donovan JL. Commentary: randomised trials of surgical and non-surgical treatment: a role model for the future. BMJ. 2008;337:a2747.PubMedCrossRef
22.
Muller ME, Nazarian S, Koch P, Schatzker J. The comprehensive classification of fractures of long bones. New York: Springer-Verlag; 1990.CrossRef
23.
Gupta A. The treatment of Colles' fracture. Immobilisation with the wrist dorsiflexed. J Bone Joint Surg Br. 1991;73(2):312–5.PubMedCrossRef
24.
Raskin KB. Management of fractures of the distal radius: surgeon's perspective. J Hand Ther. 1999;12(2):92–8.
25.
Gillespie S, Cowell F, Cheung G, Brown D. Can we reduce the incidence of complex regional pain syndrome type I in distal radius fractures? The Liverpool experience. Hand Ther. 2016;21(4):123–30.
26.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.PubMedCrossRef
27.
MacDermid JC, Turgeon T, Richards RS, et al. Patient rating of wrist pain and disability: a reliable and valid measurement tool. J Orthop Trauma. 1998;12:577–86.PubMedCrossRef
28.
29.
Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (Disabilities of the Arm, Shoulder and Hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996;29(6):602–8.PubMedCrossRef
30.
31.
Harden RN, Bruehl S, Perez RS, et al. Validation of proposed diagnostic criteria (the ‘Budapest Criteria‘) for complex regional pain syndrome. Pain. 2010;150:268–74.PubMedPubMedCentralCrossRef
32.
Sorensen AA, Howard D, Tan WH, et al. Minimal clinically important differences of three patient-rated outcomes instruments. J Hand Surg Am. 2013;38:641–9.PubMedPubMedCentralCrossRef
33.
Franchignoni F, Vercelli S, Giordano A, Sartorio F, Bravini E, Ferriero G. Minimal clinically important difference of the Disabilities of the Arm, Shoulder and Hand outcome measure (DASH) and its shortened version (QuickDASH). J Orthop Sports Phys Ther. 2014;44(1):30–9.PubMedCrossRef
34.
35.
Caplan N, Robson H, Robson A, Barry G, Wilkes G. Associations between community-based physiotherapy for musculoskeletal injury and health related quality of life (EQ-5D): a multi-centre retrospective analysis. Health Qual Life Outcomes. 2017;15(1):212 Published 2017 Oct 25.PubMedPubMedCentralCrossRef
36.
37.
Olsen MF, Bjerre E, Hansen MD, Hilden J, Landler NE, Tendal B, Hróbjartsson A. Pain relief that matters to patients: systematic review of empirical studies assessing the minimum clinically important difference in acute pain. BMC Med. 2017;15(1):35.PubMedPubMedCentralCrossRef
38.
Walenkamp MM, de Muinck Keizer RJ, Goslings JC, et al. The minimum clinically important difference of the patient-rated wrist evaluation score for patients with distal radius fractures. Clin Orthop Relat Res. 2015;473:3235–41.PubMedPubMedCentralCrossRef
39.
Bartl C, Stengel D, Bruckner T, et al. The treatment of displaced Intra-articular distal radius fractures in elderly patients: a Randomized Multi-center Study (ORCHID) of open reduction and volar locking plate fixation versus closed reduction and cast immobilization. Dtsch Arztebl Int. 2014;111:779–87.PubMedPubMedCentral
40.
R Core Team (2018). R: A language and environment for statistical computing. R Foundation for Statistical Computing (Version 3.4.4). Vienna, Austria. Available online at http://​www.​R-project.​org/​.
Metadata
Title
A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analysis plan
Authors
Andrew Lawson
Justine Naylor
Rachelle Buchbinder
Rebecca Ivers
Zsolt Balogh
Paul Smith
Rajat Mittal
Wei Xuan
Kirsten Howard
Arezoo Vafa
Piers Yates
Bertram Rieger
Geoff Smith
Ilia Elkinson
Woosung Kim
Jai Sungaran
Kim Latendresse
James Wong
Sameer Viswanathan
Keith Landale
Herwig Drobetz
Phong Tran
Richard Page
Raphael Hau
Jonathan Mulford
Ian Incoll
Michael Kale
Bernard Schick
Andrew Higgs
Andrew Oppy
Diana Perriman
Ian Harris
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4228-0

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