Trials / Completed
CompletedNCT01557829
Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion SNAP Trial
Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Amedica Corporation · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.
Conditions
- Disc Degeneration of Pfirrmann Grade III or Greater
- Degenerative Spondylolisthesis
- Isthmic Spondylolisthesis of Grade I or II
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Posterior lumbar interbody fusion with a PEEK cage | PEEK cage suitable for oblique placement in the lumbar spine |
| DEVICE | Posterior lumbar interbody fusion with a Valeo OL cage | Posterior lumbar interbody fusion with a single Valeo OL ceramic cage. |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2016-01-01
- Completion
- 2017-03-01
- First posted
- 2012-03-20
- Last updated
- 2017-04-04
Locations
2 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01557829. Inclusion in this directory is not an endorsement.