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Completed

NCT Number: NCT02203448

Facet Wedge Post Market Study

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

BG Unfallklinik, Frankfurt am Main, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

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.

Treatment and study plan

Facet Wedge spinal system

Device

Primary outcomes

  1. reoperation rate at the index level(s)

    Time frame: at two years

Secondary outcomes

  1. the radiographic range of motion (ROM) at the index levels

    Time frame: Pre-treatment, 6 months, 12 months, 24 months

  2. 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.

  3. functional success based on results from the Oswestry Disability Index (ODI)

    Time frame: Pre-treatment, 6 weeks, 6 months, 12 months, 24 months

  4. 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.

Sponsors and collaborators

Lead sponsor

Synthes GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 30, 2014
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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