Actively Recruiting
OssiMend BA in Posterolateral Instrumented Lumbar Fusion
Led by Collagen Matrix · Updated on 2025-10-16
120
Participants Needed
4
Research Sites
314 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material
CONDITIONS
Official Title
OssiMend BA in Posterolateral Instrumented Lumbar Fusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older at the time of consent
- Have a documented diagnosis of degenerative disc disease (DDD) that has not improved after at least 6 months of nonoperative treatment
- Have back and/or radicular pain with disc degeneration confirmed by medical history, physical exam, and imaging studies such as CT, MRI, X-ray, discography, or myelography
- Show one or more of the following findings: instability (>3mm translation or >5 degrees angulation), osteophyte formation of facet joints or vertebral endplates, decreased disc height (>2mm average depending on spinal level), herniated nucleus pulposus, or facet joint degeneration/changes
You will not qualify if you...
- Be under 18 years of age at the time of consent
- Have had prior lumbar spine fusion surgery at any level
- Currently be undergoing treatment for malignancy or have a history of cancer treatment
- Be pregnant, nursing, or planning to become pregnant within 24 months after surgery
- Have an active infection or be receiving treatment for infection
- Be involved in workers compensation claims or active litigation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
San Diego Neurosurgery
Encinitas, California, United States, 92024
Not Yet Recruiting
2
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
3
University Orthopaedic Associates, Division of OrthoNJ
Somerset, New Jersey, United States, 08873
Not Yet Recruiting
4
McKenzie-willamette Medical Center
Eugene, Oregon, United States, 97401
Completed
Research Team
M
Meenakshi Paliwal
CONTACT
P
Peggy Hansen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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