Facet Wedge Post Market Study

NCT02203448 | Completed DMC

• 1 other identifier: CT13/01
• Study Type: observational
• Target: 50
• Locations: 2 countries
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• reoperation rate at the index level(s)

  at two years

Secondary Outcomes (4)

• the radiographic range of motion (ROM) at the index levels

  Pre-treatment, 6 months, 12 months, 24 months

• patient (back and leg) pain reported on a Numeric Rating Scale (NRS)

  pre-treatment, prior to D/C, 6 weeks, 6 months, 12 months, 24 months.

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

  Pre-treatment, 6 weeks, 6 months, 12 months, 24 months

• Adverse events

  Throughout the study

Study Arms (1)

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

Interventions

Facet Wedge spinal system DEVICE

FACET WEDGE spinal system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The cases in the cohort are selected from patients treated in hospitals.

You may qualify if:

• 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.

You may not qualify if:

• 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 decision to use implants other than the device under investigation.

Sponsors & Collaborators

• Synthes GmbH: lead

Study Sites (3)

BG Unfallklinik

Frankfurt am Main, 60439, Germany

Location

Schon Klinik Munchen

München, 81547, Germany

Location

UVN

Ružomberok, Slovakia

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Frank Kandziora, PhD

  Berufsgenossenschaftliche Unfallklinik, Frankfurt am Main, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 30, 2014
• Study Start: May 1, 2014
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: October 19, 2018

Record last verified: 2018-10

Locations

DE (2); SL (1)