Proximal ROw carpectOmy versus four-corner Fusion (PROOF-trial) for osteoarthritis of the wrist: study protocol for multi-institutional double-blinded randomized controlled trial

Trials

Study Protocol

Jouko Miettunen¹  Teemu Karjalainen²  Eero Waris³  Mikko Alanen³  Samuli Aspinen³  Jorma Ryhänen³  Susanna Stjernberg-Salmela³ 

[1]Center for Life Course Health Research, University of Oulu, Oulu, Finland

[2]Department of Hand Surgery, Central Hospital of Central Finland, Jyväskylä, Finland

[3]Department of Hand Surgery, Helsinki University Hospital, Helsinki, Finland

关键词: Arthrodesis;    Arthroplasty;    Osteoarthritis;    Randomized controlled trial;    Wrist injuries;   

DOI  :  10.1186/s13063-023-07544-1

 received in 2022-11-14, accepted in 2023-07-25,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundScapholunate advanced collapse (SLAC) and scaphoid non-union advanced collapse (SNAC) are common types of wrist osteoarthritis (OA). Non-operative treatment consists of pain medication, splinting, and avoiding activities that induce pain. However, in case a course of conservative treatment is unsuccessful, operative treatment is needed. The two most conventional operative approaches for SLAC/SNAC OA are four-corner arthrodesis (FCA) and proximal row carpectomy (PRC). Although FCA is the gold-standard operative technique and may lead to superior grip strength, the evident benefit of PRC is that it obviates any need for hardware removal and controlling for bony union. To date, no high-quality randomized controlled trial comparing FCA and PRC exists. As clinical outcomes seem comparable, a trial that assesses patient-reported outcomes, adverse events, and secondary operations may guide clinical decision making between these two procedures. Thus, the aim of this multi-institutional double-blind randomized controlled trial is to study whether PRC is non-inferior to FCA in treating SLAC/SNAC OA. We hypothesize that PRC is non-inferior to FCA with lower economic expanses.MethodsThe trial is designed as a randomized, controlled, patient- and outcome-assessor blinded multicenter, two-armed 1:1 non-inferiority trial. Patients with SLAC/SNAC-induced wrist pain meeting trial inclusion criteria will undergo wrist arthroscopy to further assess eligibility. Each patient eligible for the trial will be randomly assigned to undergo either FCA or PRC. The primary endpoint of this study is the Patient Rated Wrist Evaluation (PRWE) at 1-year after FCA versus PRC. Secondary outcomes include Quick-Disabilities of the Arm, Shoulder and Hand, EQ-5D-5L, pain, grip strength, wrist active range of motion, radiographic evaluation, and adverse events. Trial design, methods, and statistical analysis plan will be presented here.DiscussionWe present an RCT design comparing FCA vs PRC for SLAC/SNAC-induced OA. The results of this trial will assist in decision making when planning surgery for SLAC/SNAC.Trial registrationClinicalTrials.gov NCT04260165. Registered February 7, 2020.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

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