Status:
RECRUITING
OssiMend BA in Posterolateral Instrumented Lumbar Fusion
Lead Sponsor:
Collagen Matrix
Conditions:
Spinal Disease
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Subject must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings:
- Instability as defined by \>3mm translation or \>5 degrees angulation
- Osteophyte formation of facet joints or vertebral endplates
- Decreased disc height, on average by \>2mm, but dependent upon the spinal level
- Herniated nucleus pulposus
- Facet joint degeneration/changes
Exclusion
- Subject is under 18 years of age at the time of consent
- Subject has had prior lumbar spine fusion surgery at any level
- Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy
- Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis
- Subject has an active (local or systemic) infection or is undergoing adjunctive treatment for infection
- Subjects under workers compensation or active litigation
Key Trial Info
Start Date :
January 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04775537
Start Date
January 21 2021
End Date
January 30 2027
Last Update
October 16 2025
Active Locations (4)
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1
San Diego Neurosurgery
Encinitas, California, United States, 92024
2
Hartford Hospital
Hartford, Connecticut, United States, 06102
3
University Orthopaedic Associates, Division of OrthoNJ
Somerset, New Jersey, United States, 08873
4
McKenzie-willamette Medical Center
Eugene, Oregon, United States, 97401