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Spots Global Cancer Trial Database for PASS OCT® Post-market Clinical Follow-up

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: PASS OCT® Post-market Clinical Follow-up

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

Study ID: NCT02931279

Study Description

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

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hopital la Timone, Marseille, , France

Contact Details

Name: Stephane Fuentes, MD

Affiliation: Hopital la Timone, Marseille

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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