CLINICAL RESEARCH STUDY TO DEMONSTRATE EQUIVALENCE OF a -BSM^® TO AUTOGRAFT IN THE REPAIR OF PROXIMAL TIBIA FRACTURES

Participants: J. Goulet, M. Karunakar, T Le, J.M. Hall

Keywords: bone substitute material, tibial fracture, autologous bone graft

Introduction

a -BSM^® is a synthetic bone substitute material, which has a chemical composition and crystalline structure essentially identical to the calcium phosphate component of natural bone. Preclinical studies have demonstrated a -BSM^® to be safe and effective in repairing bone defects in animal models. a -BSM^® is beneficial because it avoids the problems associated with autograft and is expected to show equivalent performance to autograft. This multi-center prospective randomized clinical study, funded by the DePuy Corporation, is designed to demonstrate the equivalence of a -BSM^® to autograft in the repair of closed non-diaphyseal proximal tibial defects which have been openly reduced and internally fixated.

Materials and Methods

A total of 223 patients (approx 15 at the University of Michigan) between the ages of 18-70, needing repair of a closed non-diaphyseal proximal tibia fracture which requires treatment with a bone graft and fixation will be recruited and randomized 2:1 into two treatment groups, a -BSM and autograft, respectively. Patients will be followed for 12 months, with the primary endpoint, patient healing by 12 months, to be determined by clinical and radiographic healing of the defect as assessed by the surgeon. The radiographs will also be reviewed independently by a radiologist who is blinded with respect to treatment and clinical outcome. Patients will be followed at the usual postoperative intervals: 6 weeks, 3 months, 6 months, and 12 months. A secondary endpoint, functional impairment, will be evaluated by a patient function questionnaire (WOMAC). This questionnaire will be administered at the initial visit and at each follow-up visit.

Progress

IRB approval has been obtained for this study, and two subjects have been enrolled. Follow-up data will continue to be collected on the enrolled subjects and subject recruitment will continue.