Degenerative Disc Disease Lumbar Clinical Trial
Official title:
Post Market Study on the Safety and Efficiency of FLXfit™ TLIF Interbody Fusion Device (Cage)
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.
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 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03928041 -
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine
|
N/A | |
| Terminated |
NCT01861743 -
Multimodal Analgesia Versus Routine Care Pain Management
|
N/A |