Chronic Low Back Pain Clinical Trial
Official title:
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
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.
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