Status:
COMPLETED
Facet Wedge Post Market Study
Lead Sponsor:
Synthes GmbH
Conditions:
Chronic Low Back Pain
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 Dis...
Eligibility Criteria
Inclusion
- Subjects diagnosed with at least one of the following:
- Degenerative Disc Disease (DDD);
- Degenerative facet joint disease (isolated facet based symptomatic back pain);
- Pseudoarthrosis post anterior instrumentation;
- 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
- Preoperative 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;
- Tumor;
- Acute or chronic systemic or localized spinal infections;
- Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study;
- Subjects aged below 18 years;
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation;
- Intraoperative exclusion criteria:
- Intraoperative decision to use implants other than the device under investigation.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02203448
Start Date
May 1 2014
End Date
August 31 2018
Last Update
October 19 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
BG Unfallklinik
Frankfurt am Main, Germany, 60439
2
Schon Klinik Munchen
München, Germany, 81547
3
UVN
Ružomberok, Slovakia