OssiMend BA in Posterolateral Instrumented Lumbar Fusion
Part of paid clinical trials in Encinitas, California.
- Sponsor
- Collagen Matrix
- Study ID
- NCT04775537
- Status
- Recruiting
Conditions
- Degenerative Disc Disease
- Spinal Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- OssiMend™ Bioactive Moldable — DEVICELumbar Spine fusion with OssiMend™ Bioactive Moldable
Study Details
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
Key Dates
- Start date
- Jan 21, 2021
- Status verified
- Jan 2025
- Primary completion
- Dec 30, 2026
- Completion
- Jan 30, 2027
Study Design
- Enrollment
- 120 participants (estimated)
Arms
- Arm: OssiMend™ Bioactive MoldablePatients undergoing Lumber Spine Fusion
Primary Outcome Measure
Fusion Success [ Time Frame: 12 months ]
Central Contacts
- Meenakshi Paliwal12014051477
- Peggy Hansen201-405-1477
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| San Diego Neurosurgery | Encinitas | California | 92024 | Kevin Yoo Kevin Yoo, M.D., F.A.A.N.S., F.A.C.S. (PRINCIPAL_INVESTIGATOR) |
| Hartford Hospital | Hartford | Connecticut | 06102 | Pedro Coutinho, MD (PRINCIPAL_INVESTIGATOR) |
| University Orthopaedic Associates, Division of OrthoNJ | Somerset | New Jersey | 08873 | Patricia Seuffert Matthew McDonnell, MD (PRINCIPAL_INVESTIGATOR) |
| McKenzie-willamette Medical Center | Eugene | Oregon | 97401 | - |
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