An observational study in Chronic Low Back Pain, Degenerative Disc Disease and Facet Joint Disease, sponsored by Synthes GmbH. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-19.
Sponsored by Synthes GmbH (part of Johnson & Johnson) · Observational
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.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's enrollment of 50 is below the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Synthes GmbH is the lead sponsor of 10 studies on the registry; none are open to participants now.
First submitted after Synthes GmbH became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
The cases in the cohort are selected from patients treated in hospitals.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects diagnosed with at least one of the following:
Exclusion Criteria:
Preoperative exclusion criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The FACET WEDGE spinal system provides additional stability to a spinal segment to enhance fusion conditions.
Device: Facet Wedge spinal system
reoperation rate at the index level(s)
Time frame: at two years
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
The nature and incidence of all procedural and post-treatment adverse events will be recorded and reported appropriately throughout the study to assess safety.
Time frame: Throughout the study
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →