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Open Access Study protocol

Surgery versus conservative treatment in patients with type A distal radius fractures, a randomized controlled trial

Monique MJ Walenkamp1*, J Carel Goslings1, Annechien Beumer2, Robert Haverlag3, Peter A Leenhouts4, Egbert JMM Verleisdonk5, Ronald SL Liem6, Jan Bernard Sintenie7, Maarten WGA Bronkhorst8, Jasper Winkelhagen9 and Niels WL Schep1

Author Affiliations

1 Trauma Unit, Department of Surgery, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, Amsterdam, DD 1100, The Netherlands

2 Department of Orthopedics, Amphia Hospital, P.O. Box 90158, Breda, RK 4800, The Netherlands

3 Department of Surgery, Onze Lieve Vrouwe Hospital, P.O. Box 95500, Amsterdam, HM 1090, The Netherlands

4 Department of Surgery, Zaans Medical Centre, P.O. Box 210, Zaandam, EE 1500, The Netherlands

5 Department of Surgery, Diakonessenhuis, P.O. Box 80250, Utrecht, TG 3508, The Netherlands

6 Department of Surgery, Groene Hart Hospital, Bleulandweg 10, Gouda, HH 2803, The Netherlands

7 Department of Surgery, Elkerliek Hospital, P.O. Box 98, Helmond, AB 5700, The Netherlands

8 Department of Surgery, Bronovo Hospital/MC Haaglanden, P.O. Box 96900, The Hague, JH 2509, The Netherlands

9 Department of Surgery, Westfriesgasthuis, P.O. Box 600, Hoorn, AR 1620, The Netherlands

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BMC Musculoskeletal Disorders 2014, 15:90  doi:10.1186/1471-2474-15-90

Published: 19 March 2014

Abstract

Background

Fractures of the distal radius are common and account for an estimated 17% of all fractures diagnosed. Two-thirds of these fractures are displaced and require reduction. Although distal radius fractures, especially extra-articular fractures, are considered to be relatively harmless, inadequate treatment may result in impaired function of the wrist. Initial treatment according to Dutch guidelines consists of closed reduction and plaster immobilisation. If fracture redisplacement occurs, surgical treatment is recommended. Recently, the use of volar locking plates has become more popular. The aim of this study is to compare the functional outcome following surgical reduction and fixation with a volar locking plate with the functional outcome following closed reduction and plaster immobilisation in patients with displaced extra-articular distal radius fractures.

Design

This single blinded randomised controlled trial will randomise between open reduction and internal fixation with a volar locking plate (intervention group) and closed reduction followed by plaster immobilisation (control group). The study population will consist of all consecutive adult patients who are diagnosed with a displaced extra-articular distal radius fracture, which has been adequately reduced at the Emergency Department. The primary outcome (functional outcome) will be assessed by means of the Disability Arm Shoulder Hand Score (DASH). Secondary outcomes comprise the Patient-Rated Wrist Evaluation score (PRWE), quality of life, pain, range of motion, radiological parameters, complications and cross-overs. Since the treatment allocated involves a surgical procedure, randomisation status will not be blinded. However, the researcher assessing the outcome at one year will be unaware of the treatment allocation. In total, 90 patients will be included and this trial will require an estimated time of two years to complete and will be conducted in the Academic Medical Centre Amsterdam and its partners of the regional trauma care network.

Dicussion

Ideally, patients would be randomised before any kind of treatment has been commenced. However, we deem it not patient-friendly to approach possible participants before adequate reduction has been obtained.

Trial registration

This study is registered at the Netherlands Trial Register (NTR3113) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on 01-10-2012.

Keywords:
Distal radius fractures; Displaced; Dislocated; Open reduction internal fixation; Volar locking plate; Closed reduction; Plaster immobilization; Randomized controlled trial; Trauma surgery; Wrist injury; Wrist function; Disability arm shoulder hand score; Patient reported outcome; Prehensile grip strength