Trials / Completed
CompletedNCT02882243
FLXfit Post Market Outcome Study Protocol
Post Market Study on the Safety and Efficiency of FLXfit™ TLIF Interbody Fusion Device (Cage)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (actual)
- Sponsor
- Foundation for Orthopaedic Research and Education · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This investigation will provide safety and effectiveness information on the use of the FLXfit™ Cage. Data will be used for Post Market follow-up of the FLXfit™ system by evaluating: * Safety as measured by the rate of serious operative and post-operative complications. * Patients' quality of life, measured by health-related quality of life questionnaires up to 24 months following the procedure, as compared to patient's baseline.
Detailed description
Interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. Patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should be skeletally mature and have completed six months of non-operative treatment
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FLXfit Cage for fusion | Evaluating patient outcomes and radiographic outcomes |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2022-01-01
- Completion
- 2022-07-01
- First posted
- 2016-08-29
- Last updated
- 2022-07-27
Source: ClinicalTrials.gov record NCT02882243. Inclusion in this directory is not an endorsement.