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Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
Sponsor: Lindenhofgruppe AG
Summary
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 monosegmental ALIF procedure L5/S1 and in monosegmental XLIF procedure L4/5
Official title: Comparison of Radiographic Fusion Rate and Clinical Outcome of Anterior Lumbar and Extreme Lateral Interbody Fusion Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen® Cellular Bone Matrix, a Prospective Randomised Assessor Blind, Monocentric Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
168
Start Date
2022-10-27
Completion Date
2027-12
Last Updated
2025-06-08
Healthy Volunteers
No
Interventions
ViviGen®
It will investigate the radiological and clinical outcome of ALIF procedure L5/S1 and XLIF L4/L5 procedure using two arms/ treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®/ rhBMP-2 ratio will be 1:1.
rhBMP-2
It will investigate the radiological and clinical outcome of ALIF procedure L5/S1 and XLIF L4/L5 procedure using two arms/ treatments, namely either ViviGen® Bone Matrix (intervention group) or rhBMP-2 (control group). ViviGen®/ rhBMP-2 ratio will be 1:1.
Locations (1)
Orthopädie Sonnenhof
Bern, Switzerland