Degenerative Disc Disease Clinical Trial
Official title:
Comparison of Radiographic Fusion Rate & Clinical Outcome of Standalone ALIF L5/S1 Performed With Either rhBMP-2 or ViviGen® Cellular Bone Matrix, a Prospective Randomized Assessor Blind, Monocentric Trial
The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in standalone ALIF procedure L5/S1
The investigator hypothesize that the intervention group administered ViviGen® would, following surgery, experience: - Comparable bony fusion rates, evaluated via CT scan one year postoperatively - Comparable clinical outcome/ simplified COMI-score one year postoperatively - Comparable/ less inpatient length of stay (LOS) - Comparable/ less healthcare costs one year postoperatively For patients included in the study, all follow-up is recorded, with regards to radiological and clinical outcome. Follow up will be evaluated after 14 days, 6 weeks, 6 and 12 months. Last follow up will be 1 year after surgery. ;
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