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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®

NCT05238740 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-06-08

No results posted yet for this study

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

Conditions

  • Spondylosis
  • Spondylolisthesis
  • Degenerative 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.

Sponsors & Collaborators

  • Lindenhofgruppe AG

    lead INDUSTRY

Principal Investigators

  • Diel Peter, Dr. med. · Orthopädie Sonnenhof, Bern

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-27
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05238740 on ClinicalTrials.gov