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OpenTrials
Completed

NCT Number: NCT02931279

PASS OCT® Post-market Clinical Follow-up

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

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Key information

Conditions

Intervertebral Disc Disease Back Injuries Bone Diseases Bone Neoplasms Fractures, Bone Musculoskeletal Diseases Neoplasms Neoplasms by Site Spinal Diseases Spinal Fractures Spinal Injuries Spinal Neoplasms Spinal Stenosis Spondylolisthesis Spondylolysis Spondylosis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital la Timone

Marseille, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PASS OCT® Spinal System

Device

Posterior osteosynthesis of the cervical and upper thoracic spine

Primary outcomes

  1. Adverse events

    Time frame: 12 months postoperatively

    To quantify and describe adverse events

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medicrea International

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Oct 13, 2016
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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