CompletedNot Applicable

PASS OCT® Post-market Clinical Follow-up

France40 participantsStarted 2016-10

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient with * degenerative disc disease or, * spondylolisthesis, or * spinal stenosis, or * trauma, or * atlanto-axial fractures with instability or * cervical tumors. * Patient operated with PASS OCT® * Patient \> 18 years * Patient affiliated to health care insurance (social security in France) * Patient able to complete a self-administered questionnaire * Patient able to understand the protocol and the planning visit * Patient able to sign an informed consent form Exclusion Criteria: * Patient unable or unwilling to sign an informed consent form * Patient unable to complete a self-administered questionnaire * Pregnant patient or intending to get pregnant within the next 3 years * Patient judged as non-compliant by the investigator or not able to come back for follow-up visits

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse events

Timeframe: 12 months postoperatively

Trial details

NCT IDNCT02931279

SponsorMedicrea International

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-01

View on ClinicalTrials.gov More Intervertebral Disc Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.