PASS MIS® Post-market Clinical Follow-up

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

Detailed Description
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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

Official Title
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Evaluation of the Efficacy and Safety of the PASS MIS® System in the Treatment of Spinal Thoracolumbar Fractures

Conditions
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Spinal Fractures

Intervention / Treatment
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* Device: PASS MIS®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PASS MIS®|Posterior mini-invasive osteosynthesis|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal stability | To evaluate though X-rays, the efficacy of the device to promote the stability of the instrumented segments. | 12 months postoperatively | 
| Spinal fusion | Radiological assessment of bony fusion | 12 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | To quantify and describe adverse events | During surgery, 1-6 months, 12 months, 24 months postoperatively | 
| Disability | To assess patients' disability through ODI questionnaire | 1-6 months, 12 months, 24 months postoperatively | 
| Patient satisfaction index | To assess patient satisfaction after surgery using a questionnaire | 1-6 months, 12 months, 24 months postoperatively | 
| Pain | To assess patient's pain using visual analogue scale | 1-6 months, 12 months, 24 months postoperatively |