PASS OCT® Post-market Clinical Follow-up

NCT02931279 | Completed

• 1 other identifier: 1701
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Adverse events

  To quantify and describe adverse events

  12 months postoperatively

Secondary Outcomes (4)

• Fusion

  1-6 months, 12 months, 24 months postoperatively

• Disability

  1-6 months, 12 months, 24 months postoperatively

• Quality of life

  1-6 months, 12 months, 24 months postoperatively

• Pain

  1-6 months, 12 months, 24 months postoperatively

Interventions

PASS OCT® Spinal System DEVICE

Posterior osteosynthesis of the cervical and upper thoracic spine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who need immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thoracic spine (Occiput-T3).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medicrea International: lead

Study Sites (1)

Hopital la Timone

Marseille, France

Location

MeSH Terms

Conditions

Intervertebral disc disease; Spondylolisthesis; Spinal Stenosis; Spinal Neoplasms; Spinal Fractures

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Bone Neoplasms; Neoplasms by Site; Neoplasms; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Stephane Fuentes, MD

  Hopital la Timone, Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: October 13, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)