Facet Wedge Post Market Study

Completed

• Conditions: Chronic Low Back Pain; Degenerative Disc Disease; Pseudo Arthrosis Post Anterior Instrumentation; Facet Joint Disease
• Interventions: Device: Facet Wedge spinal system

• Registration Number: NCT02203448
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-01
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-30
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-18
• Last Update Posted: 2018-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FACET WEDGE spinal system	Facet Wedge spinal system	The FACET WEDGE spinal system provides additional stability to a spinal segment to enhance fusion conditions.

Primary Outcome Measures

Name	Time	Method
reoperation rate at the index level(s)	at two years

Secondary Outcome Measures

Name	Time	Method
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	The nature and incidence of all procedural and post-treatment adverse events will be recorded and reported appropriately throughout the study to assess safety.

Trial Locations

Locations (3)

UVN; 🇸🇰 Ruzomberok, Slovakia

BG Unfallklinik; 🇩🇪 Frankfurt am Main, Germany

Schon Klinik Munchen; 🇩🇪 Munchen, Germany