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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02931266
Other study ID # 1102
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 2016
Est. completion date January 2018

Study information

Verified date May 2023
Source Medicrea International
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

Patients operated with PASS MIS® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017. The inclusion period will be 12 months and the follow-up 24 months


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
PASS MIS®
Posterior mini-invasive osteosynthesis

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 Spinal stability To evaluate though X-rays, the efficacy of the device to promote the stability of the instrumented segments. 12 months postoperatively
Primary Spinal fusion Radiological assessment of bony fusion 12 months postoperatively
Secondary Adverse events To quantify and describe adverse events During surgery, 1-6 months, 12 months, 24 months postoperatively
Secondary Disability To assess patients' disability through ODI questionnaire 1-6 months, 12 months, 24 months postoperatively
Secondary Patient satisfaction index To assess patient satisfaction after surgery using a questionnaire 1-6 months, 12 months, 24 months postoperatively
Secondary Pain To assess patient's pain using visual analogue scale 1-6 months, 12 months, 24 months postoperatively
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