Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PASS OCT® Spinal System | Device | Posterior osteosynthesis of the cervical and upper thoracic spine |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | To quantify and describe adverse events | 12 months postoperatively |
| 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 |
Not provided
Inclusion Criteria:
Patient with
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:
Not provided
Not provided
Not provided
Patient who need immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thoracic spine (Occiput-T3).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephane Fuentes, MD | Hopital la Timone, Marseille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital la Timone | Marseille | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C535531 | Intervertebral disc disease |
| D013168 | Spondylolisthesis |
| D013130 | Spinal Stenosis |
| D013125 | Spinal Neoplasms |
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D009140 |
| Musculoskeletal Diseases |
| D001859 | Bone Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |