Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-03-03 @ 8:12 AM
Study NCT ID:
NCT03367169
Status:
TERMINATED
Last Update Posted:
2024-05-03
First Post:
2017-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery of the Pilon Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D007869', 'term': 'Leg Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'whyStopped': 'recrutment problems', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2017-11-23', 'studyFirstSubmitQcDate': '2017-12-04', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing', 'timeFrame': 'at 45 days', 'description': 'Measure of the duration of the bandage with index form of follow-up the state cutaneous of the wound. This measure was a number.'}], 'secondaryOutcomes': [{'measure': 'AOFAS clinical score', 'timeFrame': 'pre op, 45 days, 3, 6 and 12 months', 'description': 'American Orthopedic Foot and Ankle Society was a standard method of reporting clinical status of the ankle and foot. The systems incorporate both subjective and objective factors into numerical scales to describe function, alignment, and pain. The score varies between 0 and 100, more the value is better brought up is the score'}, {'measure': 'Nach mazur and al score', 'timeFrame': 'pre op 45 days, 3, 6 and 12 months', 'description': 'The Nach mazur grading system uses 100 points to assess pain, function while wearing shoes and the range of ankle movement. The maximum score a patient with a solid ankle fusion.'}, {'measure': 'The Foot & Ankle Disability Index', 'timeFrame': 'pre op 45 days, 3, 6 and 12 months', 'description': 'The Foot and Ankle Disability Index (FADI) was designed to assess functional limitations related to foot and ankle conditions. Subjective reports of function are classified as generic or specific measures, which include condition-specific, population-specific, and patient-specific instruments. The FADI have a total point value of 100 points, more the value is better brought up is the score'}, {'measure': 'Pain', 'timeFrame': 'pre op 45 days, 3, 6 and 12 months', 'description': 'THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10)'}, {'measure': 'Complications', 'timeFrame': 'pre op 45 days, 3, 6 and 12 months', 'description': 'list of the complications'}, {'measure': 'Radiologic evaluation', 'timeFrame': 'pre op 45 days, 3, 6 and 12 months', 'description': 'Radiologic evaluation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pilon fractures', 'Osteosynthesis', 'Mini invasive plate osteosynthesis', 'Locked plate', 'Open reduction'], 'conditions': ['Pilon Fractures', 'Fractures', 'Bone', 'Leg Injuries']}, 'descriptionModule': {'briefSummary': 'The assessment consists in comparing the osteosynthesis plate with minimally invasive technique versus open reduction and internal fixation.\n\nThe aim of study is to compare (period of bandage, efficacy, safety), these two types of surgical technique by using a prospective, randomized analysis.', 'detailedDescription': "Several surgical techniques exist and among plate osteosynthesis, there is a minimally invasive method and the open reduction method.\n\nInvestigators think that the minimally invasive method with intern plate is more efficient than the open reduction method.\n\nThese techniques may better preserve perifracture soft tissues, hematoma. It may lead to a smaller muscle detachment.\n\nThe minimally invasive technique allows a more efficient vascularization of the fracture site, what would increase bone healing and the functional prognosis of tibial pilon lesions.\n\nIt's all these issues investigators would like to assess with a randomized study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 18-year-old with opened or closed pilon fracture Cauchoix type 1,\n* signed patient consent\n\nExclusion Criteria:\n\n* Open pilon fracture cauchoix type 2 or 3,\n* infection of the operating site,\n* previous osseous disease\n* patient who are unwilling or unable to give consent'}, 'identificationModule': {'nctId': 'NCT03367169', 'acronym': 'MICOPIL', 'briefTitle': 'Surgery of the Pilon Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Comparison of the Minimally Invasive Surgery Versus Open Reduction in the Surgery of the Pilon Fractures', 'orgStudyIdInfo': {'id': 'CHU-368'}, 'secondaryIdInfos': [{'id': '2017-A01735-48', 'type': 'OTHER', 'domain': '2017-A01735-48'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'minimally invasive method', 'description': 'The patients are treated with minimally invasive method', 'interventionNames': ['Procedure: minimally invasive method']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'open reduction method', 'description': 'The patients are treated with open reduction method', 'interventionNames': ['Procedure: open reduction method']}], 'interventions': [{'name': 'minimally invasive method', 'type': 'PROCEDURE', 'description': 'type of surgical technique', 'armGroupLabels': ['minimally invasive method']}, {'name': 'open reduction method', 'type': 'PROCEDURE', 'description': 'type of surgical technique', 'armGroupLabels': ['open reduction method']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Roger ERIVAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}