Trials / Terminated
TerminatedNCT01491464
A Pivotal Study of rhBMP-2/ACS/INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
A Clinical Investigation of Recombinant Human Bone Morphogenetic Protein-2 and Absorbable Collagen Sponge With the INTER FIX™ Device for Posterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Medtronic Spinal and Biologics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical trial is to assess the safety and effectiveness of the rhBMP-2/ACS/INTER FIX™ device as compared to the autograft/INTER FIX™ device in patients with symptomatic degenerative disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | rhBMP-2/ACS/INTER FIX™ | The INTER FIX™ device containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS). |
| DEVICE | Autogenous bone/INTER FIX™ | The INTER FIX™ device containing autogenous bone taken from the patient's iliac crest. |
Timeline
- Start date
- 1999-03-01
- Primary completion
- 2002-09-01
- Completion
- 2002-09-01
- First posted
- 2011-12-14
- Last updated
- 2023-05-17
Source: ClinicalTrials.gov record NCT01491464. Inclusion in this directory is not an endorsement.