Study protocol: Trial of inflation osteoplasty in the management of tibial plateau fractures

Introduction: Restoration of articular congruency is a key factor in preventing post-traumatic osteoarthritis following tibial plateau fractures. Current surgical techniques using a bone tamp carry the risk of joint perforation and comminution of the depressed fragments which affect patient outcome. Successful use of inflation osteoplasty has been reported in both in vitro studies (Broome et al. in J Orthopaed Traumatol 13(2):89-95, 2012; Mauffrey et al. in Patient Saf Surg 6:6, 2012) and case reports in the management of fractures of the calcaneus, cuboid, distal radius, tibial plateau and acetabulum (Gupta et al. in Foot Ankle Int 32(2):205-210, 2011; Heim et al. in Foot Ankle Int 29(11):1154-1157, 2008; Konig et al. in Case Rep Unfallchirurg 109(4):328-331, 2006; Reiley in J Orthop Trauma 17:141-163, 2006). The aim of our study is to assess whether the use of the balloon osteoplasty improves the quality of reduction of a depressed tibial plateau fracture when compared to traditional methods of fracture reduction. Method: This is a single-centred randomised trial. We will recruit 24 adult patients admitted with either a depressed or split depressed tibial plateau fracture (medial or lateral) requiring surgical intervention. Consenting patients will be randomly allocated to the two treatment groups. Patients with concomitant injuries influencing the management of the tibial plateau fracture will be excluded from our study. The primary outcome measure is the quality of reduction based on the post-operative CT scan. Secondary outcome measures will be any surgical complication and patient satisfaction, measured using the Oxford Knee score and SF12 questionnaire at 3, 6 and 12 months. Principal analysis will be for the success of fracture reduction from the two techniques and the effect the operative technique had on patient satisfaction and the prevalence of surgical complications. © 2013 Springer-Verlag.