NCT02931279

PASS OCT® Post-market Clinical Follow-up

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Medicrea International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Intervertebral Disc Disease
• Spondylolisthesis
• Spinal Stenosis
• Spinal Neoplasms
• Spinal Fractures

Interventions

Type	Name	Description
DEVICE	PASS OCT® Spinal System	Posterior osteosynthesis of the cervical and upper thoracic spine

Timeline

• Start date: 2016-10-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2016-10-13
• Last updated: 2023-11-27

Locations

1 site across 1 country: France