PASS OCT® Post-market Clinical Follow-up

Status Completed

Clinical Trial 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02931279
Study type	Observational
Source	Medicrea International
Contact
Status	Completed
Phase
Start date	October 2016
Completion date	January 2022

View Details

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