Trials / Terminated
TerminatedNCT01560273
Aspen Spinous Process Fixation System for Use in PLF in Patients With Spondylolisthesis
A Multi-Center Prospective Study Evaluation Aspen Spinous Process Fixation System for Use in Posterolateral Fusion (PLF) in Patients With Spondylolisthesis
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical investigation is to evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.
Detailed description
Evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Aspen Spinous Process Fixation Device | The Aspen device will be placed as posterior fixation to Posterolateral Fusion (PLF) |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2015-09-01
- Completion
- 2015-09-01
- First posted
- 2012-03-22
- Last updated
- 2019-01-09
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01560273. Inclusion in this directory is not an endorsement.