PASS OCT® Post-market Clinical Follow-up

Completed

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

• Registration Number: NCT02931279
• Lead Sponsor: Medicrea International

Brief 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.

Study Timeline

• Study First Submitted: 2016-06-27
• Study Start: 2016-10
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-13
• Primary Completion: 2022-01
• Study Completion: 2022-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events	12 months postoperatively	To quantify and describe adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hopital la Timone; 🇫🇷 Marseille, France