An observational study in Intervertebral Disc Disease, Spondylolisthesis and Spinal Stenosis, sponsored by Medicrea International. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by Medicrea International (part of Medtronic) · Observational
Prospective, multicenter non comparative and observational study (post-market clinical follow-up).
Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.
The inclusion period will be 12 months and the follow-up 24 months
The primary endpoint is to evaluate the safety of the PASS OCT® system.
The secondary endpoints are to analyze the efficacy of the system with several point of view:
63 studies on the registry are indexed under Intervertebral disc disease; 18 are open to participants now.
This study's planned enrollment of 40 is below the median of 120 across 22 observational studies indexed under Intervertebral disc disease.
Browse Intervertebral disc disease studies →Medicrea International is the lead sponsor of 8 studies on the registry; none are open to participants now.
First submitted before Medicrea International became part of Medtronic.
Counted across the registry records on this site, refreshed daily.
Patient who need immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thoracic spine (Occiput-T3).
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.
Patient with
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Posterior osteosynthesis of the cervical and upper thoracic spine
Adverse events
To quantify and describe adverse events
Time frame: 12 months postoperatively
Fusion
Radiological assessment of bony fusion
Time frame: 1-6 months, 12 months, 24 months postoperatively
Disability
To assess disability using NDI score
Time frame: 1-6 months, 12 months, 24 months postoperatively
Quality of life
To assess quality of life through mJOA scoring system
Time frame: 1-6 months, 12 months, 24 months postoperatively
Pain
To assess pain using visual analogue scale
Time frame: 1-6 months, 12 months, 24 months postoperatively
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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