A prospective, randomized study evaluating clinical and radiographic efficacy of lumbar interbody fusion performed using a truss technology–based interbody fusion device with homologous bone or bone marrow aspirate

Abstract

Background: Our group used vertebral bone marrow aspirate (BMA) with an anterior truss-based interbody implant to promote fusion. This implant has biomechanical characteristics that may enhance bone on-growth and through-growth and allow for the use of BMA clot alone. The primary end point was comparison of the proportion of patients who achieved fusion with the implant packed with either crushed cancellous homologous bone chips (CCB) alone or with BMA clot alone. Methods: Patients were randomized to receive either BMA clot or CCB in the implant. Both groups also had supplemental fixation. Clinical assessments were performed preoperatively and postoperatively at 3, 6, and 12 months, including for the Oswestry Disability Index, leg and back visual analog scale, EQ5-D, reoperations, complications, and adverse events. Radiographs were obtained prior to discharge and at 3, 6, and 12 months postoperatively. A computed tomography scan was performed 3 months postoperatively. Radiographs were assessed by an independent radiologist to determine fusion status and evidence of subsidence. Results: Between January 2015 and February 2016, 42 consecutive patients were randomized into 1 of the 2 study groups. There were significant postoperative changes within both groups in pain improvement across all outcome scales. There were no significant differences between groups in change scores from preoperative to assessments at any followup time point, with the exception of the change in EQ-5D and visual analog scale at 6 months; however, there was no difference at 3 or 12 months. There were no device-related adverse events in either group. All patients achieved grade II fusion at 3 months postoperatively. There was no significant difference in implant subsidence between groups or smokers versus nonsmokers. Conclusions: The clinical outcomes of this study suggest that reliable fusion can be obtained using an anterior truss-based implant with either CCB or BMA alone.