PASS MIS® Post-market Clinical Follow-up

Medicrea

Status: Terminated

Conditions: Spinal Fractures

Treatments: Device: PASS MIS®

Study type: Observational

Funder types: Industry

Identifiers

NCT02931266

1102

Details and patient eligibility

About

Prospective, multicenter non comparative and observational study (post-market clinical follow-up).

Full description

Patients operated with PASS MIS® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.

The inclusion period will be 12 months and the follow-up 24 months

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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