Trials / Completed
CompletedNCT01495234
Pilot Study of rhBMP-2/BCP in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
A Pilot Investigation of Recombinant Human Bone Morphogenetic Protein- 2/Biphasic Calcium Phosphate in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Medtronic Spinal and Biologics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to generate data relating to patient safety, bone generating activity associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate the feasibility of conducting a larger clinical trial in a patient population requiring spinal fusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | rhBMP-2/BCP device | The rhBMP-2/BCP device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the biphasic calcium phosphate (BCP) carrier. |
| DEVICE | rhBMP-2/BCP device | The rhBMP-2/BCP device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the biphasic calcium phosphate (BCP) carrier. |
Timeline
- Start date
- 1996-10-01
- Primary completion
- 2001-06-01
- Completion
- 2001-06-01
- First posted
- 2011-12-19
- Last updated
- 2023-05-17
Source: ClinicalTrials.gov record NCT01495234. Inclusion in this directory is not an endorsement.