Complications of iliac crest bone graft harvesting.
E D Arrington, W J Smith, H G Chambers...
https://pubmed.ncbi.nlm.nih.gov/8769465Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID05238740
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 ViviGen4 Cellular Bone Matrix, a Prospective Randomised Assessor Blind, Monocentric Trial
Led by Lindenhofgruppe AG · Updated on 2025-06-08
168
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 L5/S1 and extreme lateral interbody fusion (XLIF) at L4/5. 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 and/or 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 1:1 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.
CONDITIONS
Brief 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
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients needing a monosegmental ALIF procedure on L5/S1 or a monosegmental XLIF procedure on L4/5, with or without additional pedicular stabilization
- Diagnosed with conditions like spondylosis, spondylolisthesis, or degenerative disc disorders causing back and/or leg pain
- Age between 18 and 70 years
- Able to understand and sign the study information and informed consent
- Willing and able to complete scheduled follow-up evaluations and questionnaires
You will not qualify if you...
- Age under 18 or over 70 years
- Presence of tumor, spine trauma, known bone disease, Parkinson's disease, other central nervous system disorders, or peripheral nerve diseases or injuries
- Undergoing other spine procedures or segments not specified in inclusion
- Planned additional spine surgeries after the main surgery
- Current smokers
- Pregnant, breastfeeding, or planning pregnancy within one year after surgery
- Insufficient German language skills
- Unable to give informed consent
- Refusal to participate or unsigned consent
- Participation 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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery plus initial recovery period
Participants undergo the ALIF or XLIF fusion surgery using either ViviGen® Bone Matrix or rhBMP-2 as part of their assigned treatment group.
1 surgical visit and immediate post-operative monitoring
Post-operative Follow-up
Duration - 12 months after surgery
Participants are monitored for clinical outcomes and complications after surgery, including assessments of back and leg pain, quality of life, disability, and patient satisfaction.
Follow-up visits at 14 days, 6 weeks, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Orthopädie Sonnenhof
Bern, Switzerland, 3006
Actively Recruiting
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Research Team
D
Diel Peter, Dr. med
S
Sabine Berger
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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Brian Johnstone, Nianli Zhang, Erik I Waldorff...
https://pubmed.ncbi.nlm.nih.gov/32355628Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies.
Abhijeet Kadam, Paul W Millhouse, Christopher K Kepler...
https://pubmed.ncbi.nlm.nih.gov/27909654The rate of fusion for stand-alone anterior lumbar interbody fusion: a systematic review.
Mustfa Manzur, Sohrab S Virk, Bridget Jivanelli...
https://pubmed.ncbi.nlm.nih.gov/30872148Complications of spinal fusion with utilization of bone morphogenetic protein: a systematic review of the literature.
Kern Singh, Kasra Ahmadinia, Daniel K Park...
https://pubmed.ncbi.nlm.nih.gov/24026158A large database study of hospitalization charges and follow-up re-admissions in US lumbar fusion surgeries using a cellular bone allograft (CBA) versus recombinant human bone morphogenetic protein-2 (rhBMP-2).
Bradley Wetzell, Julie B McLean, Mark A Moore...
https://pubmed.ncbi.nlm.nih.gov/33213484