Internal plate fixation versus plaster in displaced complete articular distal radius fractures, a randomised controlled trial

Background: Of all distal radius fractures, 25 % are complete articular fractures (AO/OTA type C fractures). Two thirds of those fractures are displaced and require reduction. According to several International Guidelines, adequately reduced intra-articular distal radius fractures are best treated non-operatively with plaster immobilisation, while surgical fixation is suggested only when the articular step exceeds 2 mm after reduction. However, these recommendations are based on studies that did not differentiate between intra- and extra-articular distal radius fractures. Thus, no clear consensus about the best treatment for patients with displaced intra-articular distal radius fractures can be reached. Despite the lack of evidence, an increase in internal fixation of intra-articular distal radius fractures has been observed over the last decade. The aim of this study is to determine the difference in functional outcome following open reduction and plate fixation compared with non-operative treatment with closed reduction and plaster immobilisation in patients with a displaced intra articular distal radius fracture. Methods/Design: This multicentre randomised controlled trial will randomise between open reduction and internal plate fixation (intervention group) and closed reduction and plaster immobilisation (control group). All consecutive adult patients from 18 to 65 years with a displaced intra-articular distal radius fracture (AO/OTA type C), which has been adequately reduced at the Emergency Department according to the Dutch National Guidelines, are eligible for inclusion in this study. The primary outcome is function and pain of the wrist assessed with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes are the Disability of the Arm, Shoulder and Hand score (DASH), pain, quality of life (SF-36), range of motion, grip strength, radiological parameters, complications, crossovers and cost-effectiveness of both treatments. A total of 90 patients will be included in this study. Discussion: Although displaced intra-articular distal radius fractures are common, there is still no evidence on the optimal treatment for these fractures in patients aged 18 to 65 years. Therefore we aim to determine the difference in functional outcome between open reduction and plate fixation and closed reduction and plaster immobilisation. Trial registration: This study is registered at ClinicalTrials.gov (NCT02651779) on January 4th 2016