Facet Wedge Post Market Study
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|ClinicalTrials.gov Identifier: NCT02203448|
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : October 19, 2018
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.
|Condition or disease||Intervention/treatment|
|Chronic Low Back Pain Degenerative Disc Disease Facet Joint Disease Pseudo Arthrosis Post Anterior Instrumentation||Device: Facet Wedge spinal system|
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|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|
|Actual Study Start Date :||May 1, 2014|
|Actual Primary Completion Date :||August 31, 2018|
|Actual Study Completion Date :||August 31, 2018|
FACET WEDGE spinal system
The FACET WEDGE spinal system provides additional stability to a spinal segment to enhance fusion conditions.
Device: Facet Wedge spinal system
- 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 [ Time Frame: Throughout the study ]The nature and incidence of all procedural and post-treatment adverse events will be recorded and reported appropriately throughout the study to assess safety.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203448
|Frankfurt am Main, Germany, 60439|
|Schon Klinik Munchen|
|Munchen, Germany, 81547|
|Principal Investigator:||Frank Kandziora, PhD||Berufsgenossenschaftliche Unfallklinik, Frankfurt am Main, Germany|