PASS MIS® Post-market Clinical Follow-up

NCT02931266 | Terminated

• 1 other identifier: 1102
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, multicenter non comparative and observational study (post-market clinical follow-up).

Conditions

Spinal Fractures

Outcome Measures

Primary Outcomes (2)

• Spinal stability

  To evaluate though X-rays, the efficacy of the device to promote the stability of the instrumented segments.

  12 months postoperatively

• Spinal fusion

  Radiological assessment of bony fusion

  12 months postoperatively

Secondary Outcomes (4)

• Adverse events

  During surgery, 1-6 months, 12 months, 24 months postoperatively

• Disability

  1-6 months, 12 months, 24 months postoperatively

• Patient satisfaction index

  1-6 months, 12 months, 24 months postoperatively

• Pain

  1-6 months, 12 months, 24 months postoperatively

Interventions

PASS MIS® DEVICE

Posterior mini-invasive osteosynthesis

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 suffering from thoraco-lumbar spinal fracture and receiving a posterior osteosynthesis through a mini-invasive approach

You may qualify if:

• Patient which need to be operated to treat a fracture at the lumbar and/or thoracic spine with the PASS MIS® device from MEDICREA®
• Patient \> 18years
• Patient with a mature skeleton
• Patient able to understand the protocol and the planning visit
• Patient able to complete a self-administered questionnaire
• Patient who have signed the informed consent form

You may not qualify if:

• Patient presenting other medical indication than thoracolumbar fracture
• Patient unable or who refuse to sign an informed consent form
• Patient unable to complete a self-administered questionnaire
• Patient judged as non-compliant by the investigator or not able to come back for follow-up visits
• Patient who need to receive or who received an open procedure
• Patient who has been not implanted with the PASS MIS® system
• Pregnant women or intending to get pregnant within the next 2 years after the surgery
• Patient with contra-indications to do radiographies
• Local infectious state
• Allergy or intolerance to the materials, suspected or known
• Any contra-indications present in the notice of the product

Sponsors & Collaborators

• Medicrea International: lead

Study Sites (1)

Hopital la Timone

Marseille, France

Location

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

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: September 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)