PASS OCT® Post-market Clinical Follow-up

Medicrea

Status: Completed

Conditions: Spinal Fractures; Spondylolisthesis; Spinal Stenosis; Spinal Neoplasms; Intervertebral Disc Disease

Treatments: Device: PASS OCT® Spinal System

Study type: Observational

Funder types: Industry

Identifiers

NCT02931279

1701

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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