Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:32 PM
Study NCT ID:
NCT07281469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Functional Outcomes of Closed Reduction With Cast Versus Closed Reduction With K-Wire Fixation in Colles' Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003100', 'term': "Colles' Fracture"}], 'ancestors': [{'id': 'D000072039', 'term': 'Fracture Dislocation'}, {'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D011885', 'term': 'Radius Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two groups in the study each group contains 30patients ,group A apply plaster of Paris for colles fracture and group B patients treated with k wires and plaster of Paris'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Garland and werely score', 'timeFrame': '3 months', 'description': 'The Gartland and Werley scoring system (range 0-52) evaluates functional outcomes after distal radius fracture. Lower scores indicate better outcomes'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Colles' Fracture"]}, 'descriptionModule': {'briefSummary': "Colles' fracture is a common distal radius injury, often managed with closed reduction and Plaster of Paris (POP) casting. However, loss of alignment may occur with casting alone. Percutaneous K-wire fixation may improve fracture stability. This study aims to compare the functional outcomes of closed reduction with POP cast application versus closed reduction with K-wire fixation followed by POP cast application in the management of Colles' fractures.", 'detailedDescription': "This randomized controlled trial evaluates two commonly used treatment methods for Colles' fractures. Sixty participants were randomized into two groups: closed reduction with POP cast application, and closed reduction with percutaneous K-wire fixation followed by POP cast application. Follow-up assessments were scheduled to evaluate functional outcomes using the Gartland and Werley scoring system over a three-month period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAge 18 to 60 years\n\nBoth genders\n\nClosed Colles' fracture\n\nInjury less than 1 week old\n\nProvided informed consent\n\nExclusion Criteria:\n\nOpen fracture\n\nFracture with neurovascular injury\n\nMedically unfit for surgery\n\nContraindication noted by orthopedic surgeon or anesthetist"}, 'identificationModule': {'nctId': 'NCT07281469', 'briefTitle': "Comparison of Functional Outcomes of Closed Reduction With Cast Versus Closed Reduction With K-Wire Fixation in Colles' Fracture", 'organization': {'class': 'OTHER', 'fullName': 'Khawaja Muhammad Safdar Medical College'}, 'officialTitle': "Comparison of the Functional Outcomes of Closed Reduction and Plaster of Paris Application Versus Closed Reduction With K-Wire Fixation and Plaster of Paris Application in the Management of Colles' Fracture.", 'orgStudyIdInfo': {'id': 'KMSafdarMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Closed Reduction and Plaster of Paris Cast Application', 'description': 'Closed reduction followed by Plaster of Paris cast application', 'interventionNames': ['Procedure: Closed reduction and fracture manipulation and plaster of Paris application in group A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Closed Reduction with Percutaneous K-Wire Fixation and Plaster of Paris Cast Application', 'description': 'Closed Reduction With K-Wire Fixation and POP Cast Closed reduction followed by percutaneous K-wire fixation and Plaster of Paris cast application', 'interventionNames': ['Procedure: closed reduction and Percutaneous K-wire fixation and plaster of application is applied in group B']}], 'interventions': [{'name': 'Closed reduction and fracture manipulation and plaster of Paris application in group A', 'type': 'PROCEDURE', 'description': 'Closed reduction and manipulation of fracture and application of plaster of Paris in group A', 'armGroupLabels': ['Closed Reduction and Plaster of Paris Cast Application']}, {'name': 'closed reduction and Percutaneous K-wire fixation and plaster of application is applied in group B', 'type': 'PROCEDURE', 'description': 'Group A Participant treated with the closed reduction and manipulation and plaster of paris application is applied for colles fracture.', 'armGroupLabels': ['Closed Reduction with Percutaneous K-Wire Fixation and Plaster of Paris Cast Application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51310', 'city': 'Sialkot', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Khawaja Muhammad Safdar Medical College Sialkot', 'geoPoint': {'lat': 32.49268, 'lon': 74.53134}}], 'centralContacts': [{'name': 'DR SUQLAIN ALI DR SUQLAIN ALI, MBBS FCPS', 'role': 'CONTACT', 'email': 'maliksaqlainali@gmail.com', 'phone': '00923317949721'}]}, 'ipdSharingStatementModule': {'url': 'https://kmsmc.edu.pk/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': "IPD and supporting documents will be made available beginning 12 months after publication of the primary results. Data will remain available for a minimum of 5 years thereafter or until the end of the study's data-retention period, whichever occurs later", 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) that underlie the results of the primary and secondary outcomes will be shared after de-identification. Shared data will include demographic variables, baseline characteristics, and outcome measures collected during the trial.', 'accessCriteria': 'Access will be granted to qualified researchers affiliated with academic, nonprofit, or governmental institutions for the purpose of scientific inquiry and secondary analyses. Researchers must submit a data-access request including a brief proposal and statistical analysis plan. Upon approval, data will be shared through a secure, controlled-access data repository. Users will be required to sign a data use agreement prohibiting re-identification or unauthorized sharing of the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khawaja Muhammad Safdar Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Suqlain Ali post graduate resident', 'investigatorFullName': 'Suqlain Ali', 'investigatorAffiliation': 'Khawaja Muhammad Safdar Medical College'}}}}