Clinical trial NCT02203448: Facet Wedge Post Market Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Degenerative Disc Disease
Facet Joint Disease
Pseudo Arthrosis Post Anterior Instrumentation
Lead sponsor: Synthes GmbH
Sponsor class: INDUSTRY
First posted: 2014-07-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cases in the cohort are selected from patients treated in hospitals.

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.


Eligibility 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.

Primary outcomes:
measure: reoperation rate at the index level(s)
timeFrame: at two years
Secondary outcomes:
measure: the radiographic range of motion (ROM) at the index levels
timeFrame: Pre-treatment, 6 months, 12 months, 24 months
measure: patient (back and leg) pain reported on a Numeric Rating Scale (NRS)
timeFrame: pre-treatment, prior to D/C, 6 weeks, 6 months, 12 months, 24 months.
measure: functional success based on results from the Oswestry Disability Index (ODI)
timeFrame: Pre-treatment, 6 weeks, 6 months, 12 months, 24 months
measure: Adverse events
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: BG Unfallklinik
city: Munchen
country: Germany
facility: Schon Klinik Munchen
city: Ruzomberok
country: Slovakia
facility: UVN
Study officials:
affiliation: Berufsgenossenschaftliche Unfallklinik, Frankfurt am Main, Germany
name: Frank Kandziora, PhD
role: PRINCIPAL_INVESTIGATOR
References: