Facet Wedge Post Market Study

NCT ID: NCT02203448

Last Updated: 2018-10-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-01
• Study Completion Date: 2018-08-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

FACET WEDGE spinal system

The FACET WEDGE spinal system provides additional stability to a spinal segment to enhance fusion conditions.

Facet Wedge spinal system

Intervention Type: DEVICE

Interventions

Facet Wedge spinal system

Intervention Type: DEVICE

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

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;

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synthes GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Kandziora, PhD

Role: PRINCIPAL_INVESTIGATOR

Berufsgenossenschaftliche Unfallklinik, Frankfurt am Main, Germany

Locations

BG Unfallklinik

Frankfurt am Main, , Germany

Schon Klinik Munchen

München, , Germany

UVN

Ružomberok, , Slovakia

Countries

Germany; Slovakia

Other Identifiers

CT13/01

Identifier Type: -

Identifier Source: org_study_id