Facet Wedge Post Market Study

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203448
• Other study ID #: CT13/01
• Status: Completed
• Start date: May 1, 2014
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2018
• Source: Synthes GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Degenerative Disc Disease
• Facet Joint Disease
• Intervertebral Disc Degeneration
• Joint Diseases
• Low Back Pain
• Osteoarthritis
• Pseudarthrosis
• Pseudo Arthrosis Post Anterior Instrumentation

Intervention

Device:
• Facet Wedge spinal system

Locations

Country	Name	City	State
Germany	BG Unfallklinik	Frankfurt am Main
Germany	Schon Klinik Munchen	Munchen
Slovakia	UVN	Ruzomberok

Sponsors (1)

Lead Sponsor	Collaborator
Synthes GmbH

Countries where clinical trial is conducted

Germany,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reoperation rate at the index level(s)		at two years
Secondary	the radiographic range of motion (ROM) at the index levels		Pre-treatment, 6 months, 12 months, 24 months
Secondary	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.
Secondary	functional success based on results from the Oswestry Disability Index (ODI)		Pre-treatment, 6 weeks, 6 months, 12 months, 24 months
Secondary	Adverse events	The nature and incidence of all procedural and post-treatment adverse events will be recorded and reported appropriately throughout the study to assess safety.	Throughout the study