PASS OCT® Post-market Clinical Follow-up

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931279
• Other study ID #: 1701
• Status: Completed
• Start date: October 2016
• Est. completion date: January 2022

Study information

• Verified date: November 2023
• Source: Medicrea International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• PASS OCT® Spinal System
Posterior osteosynthesis of the cervical and upper thoracic spine

Locations

Country	Name	City	State
France	Hopital la Timone	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Medicrea International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	To quantify and describe adverse events	12 months postoperatively
Secondary	Fusion	Radiological assessment of bony fusion	1-6 months, 12 months, 24 months postoperatively
Secondary	Disability	To assess disability using NDI score	1-6 months, 12 months, 24 months postoperatively
Secondary	Quality of life	To assess quality of life through mJOA scoring system	1-6 months, 12 months, 24 months postoperatively
Secondary	Pain	To assess pain using visual analogue scale	1-6 months, 12 months, 24 months postoperatively