Arthroscopic-assisted balloon tibioplasty versus open reduction internal fixation (ORIF) for treatment of Schatzker II–IV tibial plateau fractures: study protocol of a randomised controlled trial

Abstract

IntroductionArthroscopic-assisted balloon tibioplasty is an emerging technology that has shown advantages in recovering depression of the articular surface. However, studies evaluating clinical outcomes between arthroscopic-assisted balloon tibioplasty and traditional open reduction internal fixation (ORIF) are sparse. This is the first randomised study to compare arthroscopic-assisted balloon tibioplasty with ORIF, and will provide guidance for treating patients with Schatzker types II, III and IV with depression of the medial tibial plateau only.Methods and analysisA blinded randomised controlled trial will be conducted and a total of 80 participants will be randomly divided into either the arthroscopic-assisted balloon tibioplasty group or the ORIF group, at a ratio of 1:1. The primary clinical outcome measures are the knee functional scores, Rasmussen radiological evaluation scores and the quality of reduction based on postoperative CT scan. Secondary clinical outcome measures are intraoperative blood loss, surgical duration, visual analogue scale score after surgery, hospital duration after surgery, complications and 36-Item Short-Form Health Survey score.Ethics and disseminationThis study has been reviewed and approved by the Institutional Review Board of the Second Affiliated Hospital of Wenzhou Medical University (batch: 2017–12). The results will be presented in peer-reviewed journals after completion of the study.Trial registration numberNCT03327337, Pre-results.