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
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 Type
OBSERVATIONAL
Enrollment
40
Posterior osteosynthesis of the cervical and upper thoracic spine
Hopital la Timone
Marseille, France
Adverse events
To quantify and describe adverse events
Time frame: 12 months postoperatively
Fusion
Radiological assessment of bony fusion
Time frame: 1-6 months, 12 months, 24 months postoperatively
Disability
To assess disability using NDI score
Time frame: 1-6 months, 12 months, 24 months postoperatively
Quality of life
To assess quality of life through mJOA scoring system
Time frame: 1-6 months, 12 months, 24 months postoperatively
Pain
To assess pain using visual analogue scale
Time frame: 1-6 months, 12 months, 24 months postoperatively
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