Trials / Completed
CompletedNCT01491516
TELAMON P™ Implant/INFUSE® Bone Graft/CD HORIZON® Spinal System Pilot Study
A Pilot, Prospective, Non-Randomized Clinical Investigation of TELAMON P™ Implant With INFUSE® Bone Graft and the CD HORIZON® Spinal System for Posterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Medtronic Spinal and Biologics · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this pilot study is to evaluate the feasibility of the implant ( TELAMON P™ Implant/INFUSE Bone Graft System used in conjunction with the CD HORIZON® Spinal System) as a method of facilitating lumbar spinal fusion utilizing a posterior surgical approach in patients with symptomatic degenerative disc disease. The safety and effectiveness of the implant will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TELAMON P™ /INFUSE® Bone Graft/CD HORIZON® Spinal System | The TELAMON P™/INFUSE™ Bone Graft Implant in conjunction with the CD HORIZON® Spinal System for single level lumbar fusion from L1 to S1 |
Timeline
- Start date
- 2003-07-01
- Primary completion
- 2008-04-01
- Completion
- 2008-10-01
- First posted
- 2011-12-14
- Last updated
- 2018-09-18
Source: ClinicalTrials.gov record NCT01491516. Inclusion in this directory is not an endorsement.