Spinal Fractures
Conditions
Brief summary
Prospective, multicenter non comparative and observational study (post-market clinical follow-up).
Detailed 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
Interventions
DEVICEPASS MIS®
Posterior mini-invasive osteosynthesis
Sponsors
Medicrea International
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spinal stability | 12 months postoperatively | To evaluate though X-rays, the efficacy of the device to promote the stability of the instrumented segments. |
| Spinal fusion | 12 months postoperatively | Radiological assessment of bony fusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | During surgery, 1-6 months, 12 months, 24 months postoperatively | To quantify and describe adverse events |
| Disability | 1-6 months, 12 months, 24 months postoperatively | To assess patients' disability through ODI questionnaire |
| Patient satisfaction index | 1-6 months, 12 months, 24 months postoperatively | To assess patient satisfaction after surgery using a questionnaire |
| Pain | 1-6 months, 12 months, 24 months postoperatively | To assess patient's pain using visual analogue scale |
Countries
France
Outcome results
None listed