NCT05238740View on ClinicalTrials.gov

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

NARecruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

October 27, 2022

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
SpondylosisSpondylolisthesisDegenerative Disc Disease
Interventions
OTHER

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.

OTHER

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.

Trial Locations (1)

3006

RECRUITING

Orthopädie Sonnenhof, Bern

All Listed Sponsors
lead

Lindenhofgruppe AG

INDUSTRY