Radiographic analysis of fusion success with Integra Collagen Ceramic Matrix, as compared to autograft use, in posterolateral lumbar spine arthrodesis

Study Design: Retrospective, single center, non-randomized study. Objectives: To evaluate the efficacy of Integra Collagen Ceramic Matrix (Collagen / β-TCP Composite) bone void filler in posterolateral lumbar fusions. Methods: All patients treated with Integra Collagen Ceramic Matrix (CCM) putty and/or strip during posterior or transforaminal lumbar fusion surgery between April 2007 – December 2007, and who had CT Scan images at 1 year post surgery were considered for inclusion in the study. Medical records of these patients were analyzed, and data was collected on all subjects who met the eligibility requirements. Fine-cut CT scans with sagittal and coronal reconstructions were interpreted by an independent radiologist blinded to treatment. Results: Of the 18 patients, 9 patients (50%) underwent single level fusion procedures, 5 patients (28%) had 2-level fusion surgery, 3 patients (17%) had 3-level surgery and 1 patient (5%) underwent a 4-level procedure. Fusion rates were 100% for all evaluable single level and 2-level cases. Overall fusion rate was 93.5% (29/31) of all evaluable levels. When comparing the two posterolateral sides, the autograft side and Integra CCM side resulted in nearly identical fusion rates: 29 of 31 evaluable levels (93.5%) at the autograft side and 28 of 30 evaluable levels at the Integra CCM side (93.3%) No significant differences were observed for the fusion scores in patients that received Integra CCM Putty versus Integra CCM Strip. There were no Adverse Device Effects noted. Two patients experienced Serious Adverse Events resulting in prolonged hospitalization. These SAEs were unrelated to the devices used, and resolved without residual effect. None of the 18 patients required re-operations for revision, removal or supplemental fixation. Conclusion: Integra CCM is an effective and safe alternative for the use of autograft in posterolateral lumbar fusions, with fusion rates similar or better than those reported with autograft and other bone graft alternatives.