Trials / Completed
CompletedNCT00678171
A Pilot Study to Evaluate an Osteogenic Protein 1 (OP-1) Putty Spinal System and an Autograft Spinal System
A Pilot Study to Evaluate an OP-1 Putty Spinal System and an Autograft Spinal System in Patients Requiring Transforaminal Lumbar Interbody Fusion of the Spine
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Olympus Biotech Corporation · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study will explore the use of recombinant OP-1 in conjunction with surgical treatment of single-level TLIF of the lumbar spine.
Detailed description
This pilot study is a randomized, multi-center, prospective, controlled study of the efficacy and safety of OP-1 Putty Spinal System in patients requiring a single level transforaminal interbody fusion of the lumbar spine (TLIF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TLIF with a PEEK Spacer System and XIA Spinal System | TLIF with an AVS™TL PEEK Spacer System and XIA® Spinal System using either OP-1 Putty and/or Autograft. |
Timeline
- Start date
- 2007-02-01
- Primary completion
- 2008-03-01
- Completion
- 2010-03-01
- First posted
- 2008-05-15
- Last updated
- 2014-02-05
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00678171. Inclusion in this directory is not an endorsement.