Clinical trial · Observational
PASS OCT® Post-market Clinical Follow-up
Evaluation of the Efficacy and Safety of the Cervical Posterior Fixation System PASS OCT®
NCT02931279CI-TRIAL-00071712completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intervertebral Disc Disease | — | UNRESOLVED | — |
| Spinal Fractures | — | UNRESOLVED | — |
| Spinal Neoplasms | Spinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Spinal Stenosis | — | UNRESOLVED | — |
| Spondylolisthesis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PASS OCT® Spinal System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Adverse events
- timeFrame
- 12 months postoperatively
- description
- To quantify and describe adverse events
Secondary outcomes (4)
- measure
- Fusion
- timeFrame
- 1-6 months, 12 months, 24 months postoperatively
- description
- Radiological assessment of bony fusion
- measure
- Disability
- timeFrame
- 1-6 months, 12 months, 24 months postoperatively
- description
- To assess disability using NDI score
- measure
- Quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.