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PASS OCT® Post-market Clinical Follow-up

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02931279
Recruitment Status : Unknown
Verified March 2018 by Medicrea International.
Recruitment status was:  Recruiting
First Posted : October 13, 2016
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Medicrea International

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment
Intervertebral Disc Disease Spondylolisthesis Spinal Stenosis Spinal Neoplasms Spinal Fractures Device: PASS OCT® Spinal System

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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Efficacy and Safety of the Cervical Posterior Fixation System PASS OCT®
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: PASS OCT® Spinal System
    Posterior osteosynthesis of the cervical and upper thoracic spine

Outcome Measures
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Primary Outcome Measures :
  1. Adverse events [ Time Frame: 12 months postoperatively ]
    To quantify and describe adverse events


Secondary Outcome Measures :
  1. Fusion [ Time Frame: 1-6 months, 12 months, 24 months postoperatively ]
    Radiological assessment of bony fusion

  2. Disability [ Time Frame: 1-6 months, 12 months, 24 months postoperatively ]
    To assess disability using NDI score

  3. Quality of life [ Time Frame: 1-6 months, 12 months, 24 months postoperatively ]
    To assess quality of life through mJOA scoring system

  4. Pain [ Time Frame: 1-6 months, 12 months, 24 months postoperatively ]
    To assess pain using visual analogue scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931279


Contacts
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Contact: Estelle Douceron, PhD clinicalstudy@medicrea.com

Locations
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France
Hopital la Timone Recruiting
Marseille, France
Contact: Stephane Fuentes, MD         
Contact: Benjamin Blondel, MD         
Sponsors and Collaborators
Medicrea International
Investigators
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Principal Investigator: Stephane Fuentes, MD Hopital la Timone, Marseille
More Information
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Responsible Party: Medicrea International
ClinicalTrials.gov Identifier: NCT02931279    
Other Study ID Numbers: 1701
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Spinal Neoplasms
Spinal Stenosis
Spondylolisthesis
Spinal Fractures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
 Spondylosis
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone
Bone Neoplasms
Neoplasms by Site
Neoplasms