Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-31 @ 3:29 AM
Study NCT ID:
NCT06883435
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2025-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Cannulated Screws Versus Open Reduction and Internal Fixation in the Treatment of Displaced Isolated Medial Malleolar Fractures in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070799', 'term': 'Open Fracture Reduction'}], '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-18', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AOFAS (American association of foot and ankle society) ankle-hind foot score', 'timeFrame': 'Baseline', 'description': 'American association foot and ankle society score for foot and ankle conditions'}], 'secondaryOutcomes': [{'measure': 'Foot and ankle ability measure (FAAM)', 'timeFrame': 'baseline', 'description': 'Patient reported outcome measure for foot and ankle condition'}, {'measure': 'visual analogue scale (VAS)', 'timeFrame': 'baseline', 'description': 'method of pain assessment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Isolated medial malleolar fractures, Displaced, Percutaneous fixation, open reduction, Cannulated screws'], 'conditions': ['Medial Malleolus']}, 'referencesModule': {'references': [{'pmid': '40711571', 'type': 'DERIVED', 'citation': 'Ahmed KFE. Percutaneous versus open cannulated screws fixation for displaced isolated medial malleolar fractures in adults: a randomized controlled clinical trial. Arch Orthop Trauma Surg. 2025 Jul 25;145(1):385. doi: 10.1007/s00402-025-06000-w.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this prospective randomized controlled trial is to compare the functional and radiographic outcomes of closed reduction and percutaneous cannulated screws fixation and ORIF in treatment of displaced isolated medial malleolar fractures.', 'detailedDescription': 'Medial malleolar (MM) fractures occur in about 50% of all ankle fractures, and may occur as isolated MM fractures or as part of a bi- or tri-malleolar ankle fractures.\n\nMM fractures may occur following road traffic accident, twisting injury to ankle, assault, and falling from height.\n\nWhen MM fractures occurring as a part of a bi- or tri-malleolar ankle fractures, MM fractures are typically treated with surgical fixation. Isolated non-displaced MM fractures can be treated conservatively by below knee cast application. Displaced isolated MM fractures are usually treated surgically.\n\nMany fixation techniques for MM fractures have been proposed including; unicortical partially threaded compression screws, bicortical fully threaded screws, buttress or neutralization plates, and tension band wiring. The choice of a particular fixation technique depends on the fracture geometry and the extent of comminution. Surgical procedures can be done by open reduction internal fixation (ORIF) or closed reduction percutaneous fixation.\n\nIn comparison to an ORIF, a percutaneous approach to MM fractures have potential advantages of decreased surgical morbidity, decreased postoperative pain, and decreased risk of wound complications. However, without direct fracture site visualization, it is possible that acceptable reduction could be hindered, leading to higher rates of nonunion and malunion. Some studies have shown that even in unstable medial malleolus fractures percutaneous screw fixation is excellent technique.\n\nThere is dilemma in the existing literature which treatment method is better for MM fractures management. Up to my knowledge, there is no comparative prospective study of ORIF versus percutaneous approach in surgical treatment of isolated medial malleolar fractures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients with closed, displaced (˃2mm), isolated medial malleolar fractures of Herscovici type B or C.\n\nExclusion Criteria:\n\n* comminuted fractures, open fractures, bi-, tri-, or quadri-malleolar ankle fractures, associated syndesmotic or lateral collateral ligament injuries, skeletally immature patients, any other ipsilateral lower limb fractures, or previously fractured ankle.'}, 'identificationModule': {'nctId': 'NCT06883435', 'briefTitle': 'Percutaneous Cannulated Screws Versus Open Reduction and Internal Fixation in the Treatment of Displaced Isolated Medial Malleolar Fractures in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'A Prospective Comparative Study Between Percutaneous Cannulated Screws and Open Reduction and Internal Fixation in Treatment of Displaced Isolated Medial Malleolar Fractures', 'orgStudyIdInfo': {'id': 'Soh-Med-23-03-09PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'closed reduction and percutaneous fixation (CRPF)', 'description': 'percutaneous cannulated screws fixation of medial malleolus', 'interventionNames': ['Procedure: closed reduction and percutaneous fixation of medial malleolus']}, {'type': 'EXPERIMENTAL', 'label': 'open reduction and internal fixation (ORIF)', 'description': 'Open reduction and screw fixation of medial malleolus', 'interventionNames': ['Procedure: open reduction and screw fixation of medial malleolus']}], 'interventions': [{'name': 'closed reduction and percutaneous fixation of medial malleolus', 'type': 'PROCEDURE', 'description': 'No incision is made for fracture reduction, a pointed reduction clamp is applied to reduce the fracture, two 4 mm partially threaded cannulated cancellous screws are inserted over guide wires through stab incisions. Fluoroscopy is used to assess reduction.', 'armGroupLabels': ['closed reduction and percutaneous fixation (CRPF)']}, {'name': 'open reduction and screw fixation of medial malleolus', 'type': 'PROCEDURE', 'description': 'An incision is made over the fracture; the MM fracture is reduced under direct vision. fixation is performed with two 4mm cannulated partially threaded cancellous screws. fluoroscopy is used to confirm reduction.', 'armGroupLabels': ['open reduction and internal fixation (ORIF)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'SohagU', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Khalaf fathy elsayed Ahmed', 'investigatorAffiliation': 'Sohag University'}}}}