Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-29 @ 6:40 AM
Study NCT ID:
NCT04370561
Status:
COMPLETED
Last Update Posted:
2020-05-05
First Post:
2020-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Following Semitubular Plate vs. Polyaxial Locking Plates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064386', 'term': 'Ankle Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-01', 'studyFirstSubmitDate': '2020-04-20', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ankle function', 'timeFrame': '12 month', 'description': 'Clinical objective ankle function assessed by Olerud and Molander ankle score (OMAS)'}], 'secondaryOutcomes': [{'measure': 'Ankle function', 'timeFrame': '12 month', 'description': 'Clinical objective ankle function assessed by Foot and Ankle outcome score (FAOS)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle Fractures']}, 'referencesModule': {'references': [{'pmid': '33563235', 'type': 'DERIVED', 'citation': 'Zyskowski M, Wurm M, Greve F, Pesch S, von Matthey F, Pfluger P, Cronlein M, Biberthaler P, Kirchhoff C. Is early full weight bearing safe following locking plate ORIF of distal fibula fractures? BMC Musculoskelet Disord. 2021 Feb 9;22(1):159. doi: 10.1186/s12891-021-04009-x.'}]}, 'descriptionModule': {'briefSummary': 'In this prospective study, all patients with distal fibula fractures (AO 44 B1.1, B1.2, B1.3), with indication for surgery were included. Patients were randomized to either the DePuy Synthes® one-third semitubular plate (Group I) or NEWCLIP TECHNICS, Active Ankle® polyaxial locking plate (Group II). In Group II early weight bearing was allowed after two weeks postoperatively. Primary outcome parameter was function of the ankle joint, assessed by the Olerud and Molander ankle score (OMAS), Foot and Ankle outcome score (FAOS) and Karlsson and Peterson Scoring System for Ankle function (KPSS). Secondary outcome parameter were postoperative complications. Superficial wound infection, delayed wound healing, mechanically prominent implant, skin irritations were considered as minor and deep wound infection, material loosening, loss of reduction were regarded as major complications requiring revision surgery. Clinical and radiological follow-up were performed 6 and 12 weeks, 6 months and 1 year postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 65 years\n* Fracture of the distal fibula (AO 44 B1.1, B1.2, B1.3)\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* mental disorders\n* comprehensive legal support.\n* pathological and/or osteoporotic fracture\n* open fracture'}, 'identificationModule': {'nctId': 'NCT04370561', 'briefTitle': 'Outcome Following Semitubular Plate vs. Polyaxial Locking Plates', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'a Prospective Randomized Study on the Outcome Following Osteosynthesis of Distal Fibula Fracture Using Semitubular Plate in AO Technique vs. Polyaxial Locking Plates', 'orgStudyIdInfo': {'id': 'ActiveAnkle_0815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1/3 tubular plate', 'description': 'Standard care according to AO guidelines using the Implant "1/3 tubular plate"', 'interventionNames': ['Procedure: ORIF non-locking']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active ankle plate', 'description': 'Actual care using the new implant using the Implant "Active ankle plate"', 'interventionNames': ['Procedure: ORIF locking']}], 'interventions': [{'name': 'ORIF non-locking', 'type': 'PROCEDURE', 'description': 'Open reduction and internal fixation using 1/3 tubular plate', 'armGroupLabels': ['1/3 tubular plate']}, {'name': 'ORIF locking', 'type': 'PROCEDURE', 'description': 'Open reduction and internal fixation using active ankle polyaxial locking plate', 'armGroupLabels': ['Active ankle plate']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chlodwig Kirchhoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinik für Unfallchirurgie, Klinikum rechts der Isar, TU München'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Dr. Chlodwig Kirchhoff', 'investigatorAffiliation': 'Technical University of Munich'}}}}