Trials / Terminated
TerminatedNCT00697827
A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate Degenerative Lumbar Spinal Stenosis
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Synthes USA HQ, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Interspinous Spacer device | Device: In-Space |
| DEVICE | Interspinous Process Distraction Device | Device: X STOP |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2011-06-01
- Completion
- 2011-06-01
- First posted
- 2008-06-16
- Last updated
- 2012-06-11
- Results posted
- 2012-06-05
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00697827. Inclusion in this directory is not an endorsement.