Trials / Completed
CompletedNCT01494454
Clinical Study of rhBMP-2/BCP With the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
A Clinical Study of Recombinant Human Bone Morphogenetic Protein-2 and Biphasic Calcium Phosphate With Either the TSRH® Spinal System or the CD Horizon® Spinal System for Posterolateral Lumbar Fusion in Patients With DDD
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 197 (actual)
- Sponsor
- Medtronic Spinal and Biologics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to assess the safety and effectiveness of the rhBMP/BCP/TRSH Spinal System in treatment of the patients with degenerative disc disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | rhBMP-2/BCP/TSRH® or rhBMP-2/BCP/CD HORIZON® Spinal System | rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, either the TSRH® Spinal System or CD HORIZON® Spinal System. |
| DEVICE | Autograft/TSRH® or autograft/CD HORIZON® Spinal System. | Either the TSRH® Spinal System or the CD HORIZON® Spinal System with autogenous bone taken from the patient's iliac crest. |
Timeline
- Start date
- 1999-08-01
- Primary completion
- 2007-11-01
- Completion
- 2007-11-01
- First posted
- 2011-12-19
- Last updated
- 2023-05-17
Source: ClinicalTrials.gov record NCT01494454. Inclusion in this directory is not an endorsement.