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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects diagnosed with at least one of the following:
✓. Subjects who are a fusion candidate for single or multiple levels fusion between L1-S1;
✓. Subjects, who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Exclusion criteria
✕. Segmental instability of the index level in case of planned stand-alone FACET WEDGE usage;
✕. Unilateral application , except in combination with pediclescrew fixation on the contralateral side;
✕. Compromised facets due to decompression techniques;
✕. Spondylolisthesis;
✕. Fracture or other instabilities of the posterior elements;