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

Lauri Raittio, Antti Launonen, Teemu Hevonkorpi, Toni Luokkala, Juha Kukkonen, Aleksi Reito, Bakir Sumrein, Minna Laitinen, Ville M Mattila, Lauri Raittio, Antti Launonen, Teemu Hevonkorpi, Toni Luokkala, Juha Kukkonen, Aleksi Reito, Bakir Sumrein, Minna Laitinen, Ville M Mattila

Abstract

Background: Distal 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.

Methods: This 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.

Discussion: This 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 registration: ClinicalTrials.gov identifier: NCT02894983 22 August 2016.

Keywords: Clinical protocols; Colles’ fracture; Conservative treatment; Pain; Prospective studies; Rehabilitation; Treatment outcome.

Conflict of interest statement

Authors’ information

Not applicable.

Ethics approval and consent to participate

The Regional Ethics Committee of Tampere University Hospital has approved the protocol of the trial and additional papers, including consent form, patient information sheet and questionnaires. (Approval number: R16035). The patients have to give their informed consent in order to participate to the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The flow chart of the study

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