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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02203448
Other study ID # CT13/01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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