PASS MIS® Post-market Clinical Follow-up

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-01-31

Brief Summary

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

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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

Conditions

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Spinal Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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PASS MIS®

Posterior mini-invasive osteosynthesis

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No