PASS OCT® Post-market Clinical Follow-up

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intervertebral Disc Disease Spondylolisthesis Spinal Stenosis Spinal Neoplasms Spinal Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PASS OCT® Spinal System

Posterior osteosynthesis of the cervical and upper thoracic spine

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephane Fuentes, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital la Timone, Marseille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hopital la Timone

Marseille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1701

Identifier Type: -

Identifier Source: org_study_id