PASS MIS® Post-market Clinical Follow-up

May 2, 2023 updated by: Medicrea International

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Marseille, France
        • Hôpital La Timone

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient suffering from thoraco-lumbar spinal fracture and receiving a posterior osteosynthesis through a mini-invasive approach

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicrea International

Investigators

  • Principal Investigator: Stephane Fuentes, MD, Hopital la Timone, Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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