PASS OCT® Post-market Clinical Follow-up

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intervertebral Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Neoplasms, Spinal Fractures

Intervention / Treatment
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* Device: PASS OCT® Spinal System


Participation Criteria
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Eligibility Criteria
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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) Patient able to complete a self-administered questionnaire Patient able to understand the protocol and the planning visit Patient able to sign an informed consent form 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PASS OCT® Spinal System|Posterior osteosynthesis of the cervical and upper thoracic spine|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | To quantify and describe adverse events | 12 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion | Radiological assessment of bony fusion | 1-6 months, 12 months, 24 months postoperatively | 
| Disability | To assess disability using NDI score | 1-6 months, 12 months, 24 months postoperatively | 
| Quality of life | To assess quality of life through mJOA scoring system | 1-6 months, 12 months, 24 months postoperatively | 
| Pain | To assess pain using visual analogue scale | 1-6 months, 12 months, 24 months postoperatively |