Last updated on March 2018

PASS OCT Post-market Clinical Follow-up

Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02931279

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