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.

Minimally invasive treatment of tibial plateau depression fractures using balloon tibioplasty: Clinical outcome and absorption of bioabsorbable calcium phosphate cement

“…In the future, larger studies evaluating mid- or long-term outcome should be conducted to measure clinical outcome compared to conventional fracture repositioning and osteosynthesis techniques—Wang et al described a promising study protocol for performing a randomized controlled study on this topic 26 — as well as to compare prevention of secondary osteoarthritis and to describe the long-term absorption and remodeling effect of biodegradable cements, depending on the used types of cements.…”

Arthroscopic-Guided Balloon Tibioplasty in Schatzker III Tibial Plateau Fracture

“…Wang et al 23 will conduct a blinded randomized controlled trial on 80 patients managed with arthroscopic-assisted balloon tibioplasty and open reduction and internal fixation; the outcome measure at 2-years follow-up will be clinical and radiological score, quality of reduction, intraoperative blood loss, surgical duration, postoperative pain, hospitalization, reoperation, and post-traumatic arthritis development. So more information about this novel technique can be understood by this study.…”

Treatment of tibial plateau fractures: A comparison of two different operation strategies with medium-term follow up

“…However, several pitfalls of ORIF, such as excessive bone damage and soft tissue injury, high infection risk and functional rehabilitation difficulties with delayed activity and scar formation [ 7 ]. With technological advancements, many minimally invasive surgery (MIS) techniques for TPFs, such as the balloon technique, arthroscopy and bone tamp, have been performed among orthopedic surgeons [ [8] , [9] , [10] , [11] ]. However, developing an optimal method that can treat all types of TPFs, maximize improved knee function and prevent the progression of posttraumatic arthritis is difficult.…”