PASS MIS® Post-market Clinical Follow-up

Terminated

• Conditions: Spinal Fractures

• Registration Number: NCT02931266
• Lead Sponsor: Medicrea International

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

Study Timeline

• Study First Submitted: 2016-06-27
• Study Start: 2016-09
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-13
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spinal fusion	12 months postoperatively	Radiological assessment of bony fusion
Spinal stability	12 months postoperatively	To evaluate though X-rays, the efficacy of the device to promote the stability of the instrumented segments.

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Hopital la Timone; 🇫🇷 Marseille, France