Wednesday, September 26, 2018 7:35 AM–9:00 AM ePosters

Abstract

BACKGROUND CONTEXT The need for improved fusion technology led to the development of a lumbar interbody fusion implant with unique biomechanical characteristics that has the potential to enhance bone on-growth and through-growth. The proprietary implant using truss-based technology allows loading along the trusses throughout the fusion volume of the device which may promote stem cell differentiation into osteoblast and speed up the fusion process. PURPOSE It is hypothesized that fusions performed using the truss-based technology will result in higher fusion rates and reduced times for bone formation due to the biomechanical properties of the implant design when compared to annular implant designs. The purpose of this study was to evaluate the performance of the truss-based technology with two different graft materials, crushed cancellous allograft bone or autologous bone marrow aspirate. STUDY DESIGN/SETTING Prospective, randomized clinical trial performed in a university setting. PATIENT SAMPLE Between January 2015 and February 2016, 42 consecutive patients were recruited, consented and randomized into one of two previously defined study groups and underwent the index study procedure. There was one patient in Group 2 that withdrew from the study prior to surgery. In addition, there were 2 patient deaths due to cardiac events (one in each group) determined to be unrelated to the surgical procedure. OUTCOME MEASURES The clinical outcome measures included the Oswestry Disability Index (ODI), Visual/Analog Scales (VAS) separately assessing back and leg pain, EQ5-D and adverse events. METHODS Patients were randomized into one of two treatment groups (Group 1: crushed cancellous allograft bone vs. Group 2: autologous bone marrow aspirate [BMA] both receiving one- or two-level lumbar interbody fusion with supplemental fixation. It was determined that a total of 40 patients (20 patients per group) were needed to achieve a statistical significance level of 0.05. The 4WEB Anterior Spine Truss System Interbody Fusion Device (ASTS; 4WEB Medical, Frisco, TX, USA) was used in all cases. Clinical and radiographic data was obtained prior to hospital discharge and at 3, 6 and 12-months postoperatively. All radiographs were independently reviewed. RESULTS Except for changes from the preoperative assessment for total EQ-5D (p CONCLUSIONS The clinical and radiographic results from this prospective, randomized study have shown that reliable clinical and radiographic evidence of fusion can be obtained utilizing a truss-based web technology implant independent of the use of either crushed cancellous homologous bone chips or BMA alone. As a result of these findings, there may be intraoperative biologic cost reduction implications across multiple patient populations.