Actively Recruiting
Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
Led by Lindenhofgruppe AG · Updated on 2025-06-08
168
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients indicated for a single-level ALIF procedure at L5/S1 or XLIF procedure at L4/5, with or without additional pedicular stabilization, for conditions like spondylosis, spondylolisthesis, or degenerative disc disorders causing back or leg pain
- Patients aged between 18 and 70 years
- Patients who have understood and signed the study information and informed consent form
- Patients willing and able to complete scheduled follow-up evaluations and questionnaires
You will not qualify if you...
- Patients younger than 18 years or older than 70 years
- Patients with tumors, spine trauma, known bone diseases, Parkinson's disease or similar central nervous system disorders, or diseases/injuries of peripheral nerves
- Patients undergoing procedures or spine surgeries other than those specified in the inclusion criteria
- Patients planning additional spine surgeries after the initial surgery
- Current smokers
- Pregnant or breastfeeding patients, or those planning pregnancy within one year after surgery
- Patients with insufficient German language skills
- Patients unable to give informed consent
- Patients who refuse to participate or have not signed the study consent
- Patients participating in another interventional study within 30 days before or during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Orthopädie Sonnenhof
Bern, Switzerland, 3006
Actively Recruiting
Research Team
D
Diel Peter, Dr. med
CONTACT
S
Sabine Berger
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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