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.
Study Type
OBSERVATIONAL
Enrollment
50
BG Unfallklinik
Frankfurt am Main, Germany
Schon Klinik Munchen
München, Germany
UVN
Ružomberok, Slovakia
reoperation rate at the index level(s)
Time frame: at two years
the radiographic range of motion (ROM) at the index levels
Time frame: Pre-treatment, 6 months, 12 months, 24 months
patient (back and leg) pain reported on a Numeric Rating Scale (NRS)
Time frame: pre-treatment, prior to D/C, 6 weeks, 6 months, 12 months, 24 months.
functional success based on results from the Oswestry Disability Index (ODI)
Time frame: Pre-treatment, 6 weeks, 6 months, 12 months, 24 months
Adverse events
The nature and incidence of all procedural and post-treatment adverse events will be recorded and reported appropriately throughout the study to assess safety.
Time frame: Throughout the study
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