PASS OCT® Post-market Clinical Follow-up

November 23, 2023 updated by: Medicrea International

Evaluation of the Efficacy and Safety of the Cervical Posterior Fixation System PASS OCT®

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

Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.

The inclusion period will be 12 months and the follow-up 24 months

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary endpoint is to evaluate the safety of the PASS OCT® system.

The secondary endpoints are to analyze the efficacy of the system with several point of view:

  • The quality of fusion and the time of fusion through X rays
  • the pain with VAS
  • the quality of life thanks to questionnaires: NDI (Neck Disability Index) and JOA for myelopathy
  • the daily of the patient: return to work, sport
  • the surgeon satisfaction.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

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

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 who need immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thoracic spine (Occiput-T3).

Description

Inclusion Criteria:

  • Patient with

    • degenerative disc disease or,
    • spondylolisthesis, or
    • spinal stenosis, or
    • trauma, or
    • atlanto-axial fractures with instability or
    • cervical tumors.
  • Patient operated with PASS OCT®
  • Patient > 18 years
  • Patient affiliated to health care insurance (social security in France)
  • Patient able to complete a self-administered questionnaire
  • Patient able to understand the protocol and the planning visit
  • Patient able to sign an informed consent form

Exclusion Criteria:

  • Patient unable or unwilling to sign an informed consent form
  • Patient unable to complete a self-administered questionnaire
  • Pregnant patient or intending to get pregnant within the next 3 years
  • Patient judged as non-compliant by the investigator or not able to come back for follow-up visits

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 12 months postoperatively
To quantify and describe adverse events
12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fusion
Time Frame: 1-6 months, 12 months, 24 months postoperatively
Radiological assessment of bony fusion
1-6 months, 12 months, 24 months postoperatively
Disability
Time Frame: 1-6 months, 12 months, 24 months postoperatively
To assess disability using NDI score
1-6 months, 12 months, 24 months postoperatively
Quality of life
Time Frame: 1-6 months, 12 months, 24 months postoperatively
To assess quality of life through mJOA scoring system
1-6 months, 12 months, 24 months postoperatively
Pain
Time Frame: 1-6 months, 12 months, 24 months postoperatively
To assess 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)

October 1, 2016

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimated)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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