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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
Sponsor:
Information provided by (Responsible Party):
Synthes GmbH

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 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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. reoperation rate at the index level(s) [ Time Frame: at two years ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The cases in the cohort are selected from patients treated in hospitals.
Criteria

Inclusion Criteria:

  1. 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;
  2. Subjects who are a fusion candidate for single or multiple levels fusion between L1-S1;
  3. 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:

  1. Segmental instability of the index level in case of planned stand-alone FACET WEDGE usage;
  2. Unilateral application , except in combination with pediclescrew fixation on the contralateral side;
  3. Compromised facets due to decompression techniques;
  4. Spondylolisthesis;
  5. Fracture or other instabilities of the posterior elements;
  6. Tumor;
  7. Acute or chronic systemic or localized spinal infections;
  8. Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study;
  9. Subjects aged below 18 years;
  10. 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:

  11. Intraoperative decision to use implants other than the device under investigation.

Information from the National Library of Medicine

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


Locations
Germany
BG Unfallklinik
Frankfurt am Main, Germany, 60439
Schon Klinik Munchen
Munchen, Germany, 81547
Slovakia
UVN
Ruzomberok, Slovakia
Sponsors and Collaborators
Synthes GmbH
Investigators
Principal Investigator: Frank Kandziora, PhD Berufsgenossenschaftliche Unfallklinik, Frankfurt am Main, Germany

Responsible Party: Synthes GmbH
ClinicalTrials.gov Identifier: NCT02203448     History of Changes
Other Study ID Numbers: CT13/01
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Intervertebral Disc Degeneration
Joint Diseases
Osteoarthritis
Pseudarthrosis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases
Fractures, Ununited
Fractures, Bone
Wounds and Injuries