Facet Wedge Post Market Study

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease; Chronic Low Back Pain; Facet Joint Disease; Pseudo Arthrosis Post Anterior Instrumentation
• Intervention / Treatment: Device: Facet Wedge spinal system

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Germany
  • Frankfurt am Main, Germany, 60439
    • BG Unfallklinik
  • Munchen, Germany, 81547
    • Schon Klinik Munchen
• Slovakia
  • Ruzomberok, Slovakia
    • UVN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
reoperation rate at the index level(s)	at two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Collaborators and Investigators

• Sponsor: Synthes GmbH
• Investigators: Principal Investigator: Frank Kandziora, PhD, Berufsgenossenschaftliche Unfallklinik, Frankfurt am Main, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2014
• Primary Completion (ACTUAL): August 31, 2018
• Study Completion (ACTUAL): August 31, 2018

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (ESTIMATE): July 30, 2014

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Spinal Diseases; Bone Diseases; Fractures, Ununited; Osteoarthritis; Back Pain; Low Back Pain; Joint Diseases; Intervertebral Disc Degeneration; Pseudarthrosis
• Other Study ID Numbers: CT13/01