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PASS OCT® Post-market Clinical Follow-up | Clinical Trials | Clareo Health

COMPLETED

PASS OCT® Post-market Clinical Follow-up

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

NCT02931279•Medicrea International

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+3 more criteria

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

Locations (1)

Hopital la Timone

Marseille, France

Key Dates

Start Date

October 1, 2016

Primary Completion Date

January 1, 2022

Completion Date

January 1, 2022

Last Updated

November 27, 2023

Enrollment

ESTIMATED participants

Conditions

Intervertebral Disc DiseaseSpondylolisthesisSpinal StenosisSpinal NeoplasmsSpinal Fractures

Interventions

PASS OCT® Spinal System

DEVICE

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

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Lumbar Spinal Stenosis

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RECRUITING

Multicentric Case Series of Uniportal Endoscopic Posterior Cervical Decompression for Cervical Spinal Stenosis

NCT06886802

Spinal Stenosis Cervical

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RECRUITINGPHASE4

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PASS OCT® Post-market Clinical Follow-up

Inclusion Criteria

Exclusion Criteria

Study Comparing Local/ MAC Anesthesia in Lumbar Decompression

Multicentric Case Series of Uniportal Endoscopic Posterior Cervical Decompression for Cervical Spinal Stenosis

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Home-based Cycling for People With Lumbar Spinal Stenosis

Proteomic and Histological Analysis of Ligamentum Flavum in Lumbar Stenosis

Effect of Ketamine on Intraoperative Motor Evoked Potentials