Trials / Completed
CompletedNCT02203448
Facet Wedge Post Market Study
A Multi-centre, Prospective, Single-arm Post Market Clinical Follow up Study (PMCF) of the FACET WEDGE Spinal System to Assess Outcomes in Subjects With Chronic Low Back Pain Due to Degenerative Disc Disease (DDD), Facet Joint Disease and/or Pseudo Arthrosis Post Anterior Instrumentation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- Synthes GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to Degenerative Disc Disease (DDD), facet joint disease and/or pseudo arthrosis post anterior instrumentation. The objective of this study is to assess outcomes following implantation of the FACET WEDGE spinal system when used to provide fixation of lumbar motion segments. The primary objective of this study is to determine the rate of re-operations at the index level(s). The secondary objectives of this study are to confirm the safety and performance of the device and to collect patient reported outcome data.
Conditions
- Chronic Low Back Pain
- Degenerative Disc Disease
- Facet Joint Disease
- Pseudo Arthrosis Post Anterior Instrumentation
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Facet Wedge spinal system |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2018-08-31
- Completion
- 2018-08-31
- First posted
- 2014-07-30
- Last updated
- 2018-10-19
Locations
3 sites across 2 countries: Germany, Slovakia
Source: ClinicalTrials.gov record NCT02203448. Inclusion in this directory is not an endorsement.