Comparison of volar-flexion, ulnar-deviation and functional position cast immobilization in the non-operative treatment of distal radius fracture in elderly patients: a pragmatic randomized controlled trial study protocol

BMC Musculoskeletal Disorders

Study Protocol

Toni Luokkala¹  Aleksi Reito¹  Bakir Sumrein²  Minna Laitinen²  Antti Launonen²  Juha Kukkonen³  Teemu Hevonkorpi⁴  Lauri Raittio⁴  Ville M. Mattila⁵ 

[1] Central Finland Central Hospital, Keskussairaalantie 19, 40620, Jyväskylä, Finland;Department of Orthopaedics, Unit of Musculoskeletal Surgery, Tampere University Hospital, Teiskontie 35, PL2000, 33521, Tampere, Finland;Satakunta Central Hospital, Sairaalantie 3, 28500, Pori, Finland;University of Tampere, School of Medicine, 33014, Tampere, Finland;University of Tampere, School of Medicine, 33014, Tampere, Finland;Department of Orthopaedics, Unit of Musculoskeletal Surgery, Tampere University Hospital, Teiskontie 35, PL2000, 33521, Tampere, Finland;

关键词: Colles’ fracture;    Rehabilitation;    Conservative treatment;    Treatment outcome;    Prospective studies;    Pain;    Clinical protocols;   

DOI  :  10.1186/s12891-017-1759-y

 received in 2017-02-10, accepted in 2017-09-11,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundDistal radius fractures (DRFs) are the second most common fractures, after hip fractures, seen in clinical practice. The high incidence of low-energy trauma DRFs in elderly patients raises questions about the best treatment method in terms of function, pain, and quality of life. Although the majority of these fractures are treated non-operatively with cast immobilization, valid scientific evidence of the optimal cast immobilization is lacking. In addition, several publications, including Cochrane review have outlined the need for more evidence to determine the most appropriate method of cast immobilization.MethodsThis study is a pragmatic, prospective, randomized, multi-centre trial. The trial is designed to compare two widely used cast positions (volar flexion-ulnar deviation position and functional position) for the non-operative treatment of DRF in patients over 64 years of age. The main hypothesis of the trial is that function position yields corresponding functional outcome, pain relief and quality of life when compared to the volar flexion-ulnar deviation position. The primary outcome measure is Patient Rated Wrist Evaluation (PRWE) score and the secondary outcome measures will be the Disabilities of the Arm, Shoulder and Hand (DASH) score, Visual Analogue Scale (VAS), 15-dimensional (15D) value and rate of surgical interventions. The results of the trial will be analysed after 1 and 2-years.DiscussionThis publication presents a prospective, pragmatic, randomized, national multi-centre trial study protocol. It provides details of patient flow, randomization, follow-up and methods of analysis of the material as well as publication plan.Trial registrationClinicalTrials.gov identifier: NCT02894983 22 August 2016.

【 授权许可】

CC BY   
© The Author(s). 2017