Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 4:46 AM
Study NCT ID:
NCT05084794
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2021-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Results of Middle-sized Posterior Malleolus Fractures: Fixed Versus Non-fixed
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064386', 'term': 'Ankle Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}], 'ancestors': [{'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Musculoskeletal Function Assessment (SMFA) Questionnaire', 'timeFrame': '2 year', 'description': 'Functional outcome score between 0 and 100. Higher score indicates a worse function.'}, {'measure': 'Kellgren-Lawrence grading system for osteoarthritis', 'timeFrame': '2 year', 'description': 'Grade of ankle osteroarthritis. Score between 0 to 4. Higher score indicates worse joint cartilage.'}, {'measure': 'American Orhopaedic Foot and Ankle Score (AOFAS) Score', 'timeFrame': '5 year', 'description': 'Functional outcome score between 0 and 100. Higher score indicates better function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ankle', 'fracture', 'posterior', 'malleolus', 'fixation'], 'conditions': ['Ankle Fractures', 'Posterior Malleolus Fractures']}, 'descriptionModule': {'briefSummary': 'This study aims prospective randomized comparison of mid-term clinical outcomes of middle-sized posterior malleolus fractures with and without internal fixation.', 'detailedDescription': 'Although it has traditionally been accepted that posterior malleolar fractures involving less than 25 percent of the tibial plafond do not require operative fixation, this belief is now questioned. A number of studies have shown that the posterior malleolus contributes significantly to ankle stability. Many studies have also demonstrated that postoperative outcomes are better in patients who underwent posterior malleolar reduction and fixation.\n\nThe aim of this prospective study is to show how internal fixation of the posterior malleolus, including middle-sized posterior malleolar fractures (10-25%), affects clinical outcomes and to discuss the factors that may lead to arthritis of the ankle joint. The groups will be randomized. The clinical and functional results of 40 patients who will be operated between 2015-2019 due to ankle fracture will be evaluated at short to mid-term (2-5 years). According to our hypothesis, internally fixed posterior malleolar fractures give better clinical and functional scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who were operated for ankle fractures, including posterior malleolar fracture between 10-25% of the joint surface. Two to five years of follow-up with functional and radiological outcome.\n\nExclusion Criteria:\n\nPosterior malleolar fractures accompanied by severe soft tissue damage after high-energy injury will not be included in the study. Written consent will be obtained from all participants, patients who do not give consent or refuse to participate will not be included in the study. Patients who left the study voluntarily will not be included in the statistics. Patients with additional joint disorders, previous surgery or previous history of ankle complaint will not be included.'}, 'identificationModule': {'nctId': 'NCT05084794', 'briefTitle': 'The Results of Middle-sized Posterior Malleolus Fractures: Fixed Versus Non-fixed', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Does Fixation of Medium-sized Posterior Malleolus Fractures Provide Better Outcome?', 'orgStudyIdInfo': {'id': 'A-22/01.09.2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Non-fixated', 'description': "Posterior malleolus fractures won't be fixated."}, {'type': 'EXPERIMENTAL', 'label': 'Fixated', 'description': 'Posterior malleolus fractures will be fixated with either plate or screws.', 'interventionNames': ['Procedure: Internal fixation']}], 'interventions': [{'name': 'Internal fixation', 'type': 'PROCEDURE', 'description': 'Fixation of posterior malleolus with either plate or screws.', 'armGroupLabels': ['Fixated']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Bedri Karaismailoglu', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}