Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-24 @ 2:33 PM
NCT ID:
NCT04547959
Eligibility Criteria:
Inclusion Criteria:
* Patient operated with C-CURVE TITANIUM (MEDICREA) for one or several levels (3 maximum)
* Cage implanted with the bone graft "OSMOSYS" (MEDICREA) or an auto bone graft from patients
* Patient ≥ 18 years
* Patient affiliated to health care insurance (social security in France)
* Patient who signed an informed consent form
* Patient able and willing to complete a self-administered questionnaire
* Patient able to understand protocol and the planning visit and willing to perform all of them
* Patient with a pathology indicated in the instruction for use of the implant
Exclusion Criteria:
* Patient with no preoperative data available (X-rays, questionnaires)
* Hybrid installation or cervical additional fixation
* Patient contraindicated for X-ray(s) and/or CT-Scan(s)
* Patient with contraindications indicated in the instruction for use of the implant
* Patient judged as non-compliant by the investigator, not unable to come back for the follow-up visits (for example: patient living more than 100 km away).
* Patient who declined to participate to the study or unable to give his consent Vulnerable population as explained in the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04547959
Study Brief:
Protocol Section:
NCT04547959