Trials / Completed
CompletedNCT00316121
Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease
A Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 138 (actual)
- Sponsor
- Advanced Technologies and Regenerative Medicine, LLC (ATRM) · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HEALOS and Leopard Cage | Placement in interbody space |
| DEVICE | Leopard Cage and Autograft | Placement in the interbody space |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2010-01-01
- First posted
- 2006-04-20
- Last updated
- 2011-03-03
- Results posted
- 2011-03-03
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00316121. Inclusion in this directory is not an endorsement.