Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
Study NCT ID:
NCT02931266
Status:
TERMINATED
Last Update Posted:
2023-05-06
First Post:
2016-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PASS MIS® Post-market Clinical Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016103', 'term': 'Spinal Fractures'}], 'ancestors': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Lack of inclusions', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-02', 'studyFirstSubmitDate': '2016-06-27', 'studyFirstSubmitQcDate': '2016-10-10', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spinal stability', 'timeFrame': '12 months postoperatively', 'description': 'To evaluate though X-rays, the efficacy of the device to promote the stability of the instrumented segments.'}, {'measure': 'Spinal fusion', 'timeFrame': '12 months postoperatively', 'description': 'Radiological assessment of bony fusion'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'During surgery, 1-6 months, 12 months, 24 months postoperatively', 'description': 'To quantify and describe adverse events'}, {'measure': 'Disability', 'timeFrame': '1-6 months, 12 months, 24 months postoperatively', 'description': "To assess patients' disability through ODI questionnaire"}, {'measure': 'Patient satisfaction index', 'timeFrame': '1-6 months, 12 months, 24 months postoperatively', 'description': 'To assess patient satisfaction after surgery using a questionnaire'}, {'measure': 'Pain', 'timeFrame': '1-6 months, 12 months, 24 months postoperatively', 'description': "To assess patient's pain using visual analogue scale"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Fractures']}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter non comparative and observational study (post-market clinical follow-up).', 'detailedDescription': 'Patients operated with PASS MIS® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.\n\nThe inclusion period will be 12 months and the follow-up 24 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient suffering from thoraco-lumbar spinal fracture and receiving a posterior osteosynthesis through a mini-invasive approach', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient which need to be operated to treat a fracture at the lumbar and/or thoracic spine with the PASS MIS® device from MEDICREA®\n* Patient \\> 18years\n* Patient with a mature skeleton\n* Patient able to understand the protocol and the planning visit\n* Patient able to complete a self-administered questionnaire\n* Patient who have signed the informed consent form\n\nExclusion Criteria:\n\n* Patient presenting other medical indication than thoracolumbar fracture\n* Patient unable or who refuse to sign an informed consent form\n* Patient unable to complete a self-administered questionnaire\n* Patient judged as non-compliant by the investigator or not able to come back for follow-up visits\n* Patient who need to receive or who received an open procedure\n* Patient who has been not implanted with the PASS MIS® system\n* Pregnant women or intending to get pregnant within the next 2 years after the surgery\n* Patient with contra-indications to do radiographies\n* Local infectious state\n* Allergy or intolerance to the materials, suspected or known\n* Any contra-indications present in the notice of the product'}, 'identificationModule': {'nctId': 'NCT02931266', 'briefTitle': 'PASS MIS® Post-market Clinical Follow-up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medicrea International'}, 'officialTitle': 'Evaluation of the Efficacy and Safety of the PASS MIS® System in the Treatment of Spinal Thoracolumbar Fractures', 'orgStudyIdInfo': {'id': '1102'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PASS MIS®', 'type': 'DEVICE', 'description': 'Posterior mini-invasive osteosynthesis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'country': 'France', 'facility': 'Hopital la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Stephane Fuentes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital la Timone, Marseille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medicrea International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}