Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial

Marjolein A M Mulders, Caroline A Selles, Joost W Colaris, Rolf W Peters, Mark van Heijl, Berry I Cleffken, Niels W L Schep, Marjolein A M Mulders, Caroline A Selles, Joost W Colaris, Rolf W Peters, Mark van Heijl, Berry I Cleffken, Niels W L Schep

Abstract

Background: In the past several years, an increase in open reduction and internal fixation (ORIF) for intra-articular distal radius fractures has been observed. This technique leads to a quicker recovery of function compared to non-operative treatment. However, some patients continue to have a painful and stiff wrist postoperatively. Arthroscopically assisted removal of intra-articular fracture haematoma and debris may improve the functional outcomes following operative treatment of intra-articular distal radius fractures. The purpose of this randomised controlled trial is to determine the difference in functional outcome, assessed with the Patient-Rated Wrist Evaluation (PRWE) score, after ORIF with and without an additional wrist arthroscopy in adult patients with displaced complete articular distal radius fractures.

Methods: In this multicentre trial, adult patients with a displaced complete articular distal radius fracture are randomised between ORIF with an additional wrist arthroscopy to remove fracture haematoma and debris (intervention group) and conventional fluoroscopic-assisted ORIF (control group). The primary outcome is functional outcome assessed with the PRWE score after three months. Secondary outcomes are wrist function assessed with the Disability of the Arm, Shoulder and Hand (DASH) score, postoperative pain, range of motion, grip strength, complications and cost-effectiveness. Additionally, in the intervention group, the quality of reduction, associated ligamentous injuries and cartilage damage will be assessed. A total of 50 patients will be included in this study.

Discussion: Although ORIF of intra-articular distal radius fractures leads to a quicker resume of function compared to non-operative treatment, some patients continue to have a painful and stiff wrist postoperatively. We hypothesise that, due to the removal of fracture haematoma and debris by an additional arthroscopy, functional outcomes will be better compared to the non-arthroscopically treated group.

Trial registration: ClinicalTrials.gov, NCT02660515 . Registered on 13 January 2016.

Keywords: Articular; Displaced; Distal radius fracture; Ligamentous injuries; PRWE; Randomised controlled trial; Wrist arthroscopy; Wrist function.

Conflict of interest statement

Ethics approval and consent to participate

The Institutional Review Board of the Maasstad Hospital in Rotterdam has approved the protocol on 28 October 2015 and approved the participating centres to conduct the study (NL54377.101.15). The board of directors of the Maasstad Hospital (L2015-75), Erasmus Medical Center (MEC-2016-372) and the Academic Medical Center (2016_263#A2016107) approved local feasibility on 21 December 2015, 22 June 2016 and 11 January 2017, respectively. Patients’ informed consent will be obtained from all participants.

Consent for publication

Not applicable in this section.

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
View of wrist arthroscopy portals
Fig. 2
Fig. 2
Follow-up visits

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