Trials / Completed
CompletedNCT01491386
Pivotal Study of rhBMP-2/ACS/LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 279 (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-2/ACS/LT-CAGE® device as compared to the LT-CAGE® device with autogenous bone in patients with symptomatic degenerative disc disease using an open surgical technique.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | rhBMP-2/ACS/LT-CAGE® Device | LT-CAGE® device with recombinant human bone morphogenetic protein-2 ( rhBMP-2) and the absorbable collagen sponge (ACS). |
| DEVICE | Autogenous Bone/LT-CAGE® Device | LT-CAGE® device with autogenous bone taken from the iliac crest. |
Timeline
- Start date
- 1998-08-01
- Primary completion
- 2002-10-01
- Completion
- 2002-10-01
- First posted
- 2011-12-14
- Last updated
- 2023-05-17
Source: ClinicalTrials.gov record NCT01491386. Inclusion in this directory is not an endorsement.