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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT02931266
Eligibility Criteria:
Inclusion Criteria:
* Patient which need to be operated to treat a fracture at the lumbar and/or thoracic spine with the PASS MIS® device from MEDICREA®
* Patient \> 18years
* Patient with a mature skeleton
* Patient able to understand the protocol and the planning visit
* Patient able to complete a self-administered questionnaire
* Patient who have signed the informed consent form
Exclusion Criteria:
* Patient presenting other medical indication than thoracolumbar fracture
* Patient unable or who refuse to sign an informed consent form
* Patient unable to complete a self-administered questionnaire
* Patient judged as non-compliant by the investigator or not able to come back for follow-up visits
* Patient who need to receive or who received an open procedure
* Patient who has been not implanted with the PASS MIS® system
* Pregnant women or intending to get pregnant within the next 2 years after the surgery
* Patient with contra-indications to do radiographies
* Local infectious state
* Allergy or intolerance to the materials, suspected or known
* Any contra-indications present in the notice of the product
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02931266
Study Brief:
Protocol Section:
NCT02931266