NCT Number: NCT02203448
Facet Wedge Post Market Study
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
BG Unfallklinik, Frankfurt am Main, Germany
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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;
- Subjects who are a fusion candidate for single or multiple levels fusion between L1-S1;
- 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:
- Segmental instability of the index level in case of planned stand-alone FACET WEDGE usage;
- Unilateral application , except in combination with pediclescrew fixation on the contralateral side;
- Compromised facets due to decompression techniques;
- Spondylolisthesis;
- Fracture or other instabilities of the posterior elements;
- Tumor;
- Acute or chronic systemic or localized spinal infections;
- Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study;
- Subjects aged below 18 years;
- 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:
- Intraoperative decision to use implants other than the device under investigation.
Treatment and study plan
Primary outcomes
-
reoperation rate at the index level(s)
Time frame: at two years
Secondary outcomes
-
the radiographic range of motion (ROM) at the index levels
Time frame: Pre-treatment, 6 months, 12 months, 24 months
-
patient (back and leg) pain reported on a Numeric Rating Scale (NRS)
Time frame: 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)
Time frame: Pre-treatment, 6 weeks, 6 months, 12 months, 24 months
-
Adverse events
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Synthes GmbH
Industry
Registry information
Official study 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
Important dates
- Study start
- 2014
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Jul 30, 2014
- Registry last updated
- Oct 19, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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