PASS MIS® Post-market Clinical Follow-up

Spinal Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02931266
• Other study ID #: 1102
• Status: Terminated
• Start date: September 2016
• Est. completion date: January 2018

Study information

• Verified date: May 2023
• Source: Medicrea International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Fractures

Intervention

Device:
• PASS MIS®
Posterior mini-invasive osteosynthesis

Locations

Country	Name	City	State
France	Hopital la Timone	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Medicrea International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spinal stability	To evaluate though X-rays, the efficacy of the device to promote the stability of the instrumented segments.	12 months postoperatively
Primary	Spinal fusion	Radiological assessment of bony fusion	12 months postoperatively
Secondary	Adverse events	To quantify and describe adverse events	During surgery, 1-6 months, 12 months, 24 months postoperatively
Secondary	Disability	To assess patients' disability through ODI questionnaire	1-6 months, 12 months, 24 months postoperatively
Secondary	Patient satisfaction index	To assess patient satisfaction after surgery using a questionnaire	1-6 months, 12 months, 24 months postoperatively
Secondary	Pain	To assess patient's pain using visual analogue scale	1-6 months, 12 months, 24 months postoperatively