Trials / Unknown
UnknownNCT00798902
Pilot Study to Assess Safety/Preliminary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery
A Multi-Center, Prospective, Parallel Group, Randomized, Pilot Study Evaluating Safety and Preliminary Effectiveness Of Prefix Compared To Iliac Crest Bone In Subjects With DDD Undergoing Transforaminal Lumbar Interbody Fusion
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- Sponsor
- BioSurface Engineering Technologies, Inc · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from L2-S1.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules | 150 micrograms/cc BVF |
| OTHER | Iliac crest autograft | autograft |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2012-07-01
- Completion
- 2012-10-01
- First posted
- 2008-11-26
- Last updated
- 2012-03-09
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00798902. Inclusion in this directory is not an endorsement.