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Facet Wedge Post Market Study

NCT02203448 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2018-10-19

No results posted yet for this study

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 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.

Conditions

  • Chronic Low Back Pain
  • Degenerative Disc Disease
  • Facet Joint Disease
  • Pseudo Arthrosis Post Anterior Instrumentation

Interventions

DEVICE

Facet Wedge spinal system

Sponsors & Collaborators

  • Synthes GmbH

    lead INDUSTRY

Principal Investigators

  • Frank Kandziora, PhD · Berufsgenossenschaftliche Unfallklinik, Frankfurt am Main, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-01
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Germany
  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02203448 on ClinicalTrials.gov