Comparing Bone Fusion and Outcomes of ALIF and XLIF Spine Surgeries Using ViviGen or rhBMP-2 A Randomized, Assessor-Blind Study in Adults Aged 18 to 70

What this Trial Is About

Researchers are investigating the potential for bone fusion using ViviGen4 bone graft substitute compared to recombinant human bone morphogenetic protein-2 rhBMP-2 in patients undergoing specific spinal fusion surgeries, namely monosegmental anterior lumbar interbody fusion ALIF at L5S1 and extreme lateral interbody fusion XLIF at L45. The study aims to measure how well these treatments promote fusion and improve clinical outcomes in conditions like spondylosis, spondylolisthesis, and degenerative disc disease causing back andor leg pain. Participants are randomly assigned to receive either 5-5.4 cc of ViviGen4 or 4-6 mg of rhBMP-2 during their ALIF or XLIF spinal fusion surgery. Follow-up visits are scheduled at 14 days, 6 weeks, 6 months, and 12 months after surgery to evaluate the fusion progress and clinical outcomes. The study will assess the bone fusion rate using CT scans at 6 or 12 months, comparing the two treatments. The trial is monocentric and assessor-blinded, with a 11 ratio for the two treatment groups. During the study, participants will undergo radiological assessments including CT scans to confirm bone fusion and complete questionnaires to report back and leg pain, quality of life, disability in daily and work activities, and patient satisfaction. Safety and complications will be monitored at multiple time points. The primary outcome is the rate of interbody bony fusion confirmed by CT, with secondary outcomes focusing on pain levels, functional limitations, quality of life, and adverse effects. The total participation duration extends up to one year after surgery.

Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®