Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT05754320
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2023-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TBW vs Plating in Olecranon Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092470', 'term': 'Olecranon Fracture'}], 'ancestors': [{'id': 'D000092482', 'term': 'Elbow Fractures'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014458', 'term': 'Ulna Fractures'}, {'id': 'D005543', 'term': 'Forearm Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disabilities of the Arm, Shoulder and Hand score', 'timeFrame': '1 year', 'description': '1-year postoperative patient reported Disabilities of the Arm, Shoulder and Hand score. Scale - 0 (no disability) to 100 (most severe disability)'}], 'secondaryOutcomes': [{'measure': 'Oxford elbow score', 'timeFrame': '1 year', 'description': '1-year postoperative patient-reported Oxford elbow score. Scale - 0 (worst elbow functional score) to 48 (normal elbow functional score)'}, {'measure': 'Union rate', 'timeFrame': '1 year', 'description': 'Union rate'}, {'measure': 'Complication rate', 'timeFrame': '>1 year', 'description': 'Long term complication rate'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Olecranon Fracture']}, 'descriptionModule': {'briefSummary': 'Background: While the tension band wiring (TBW) technique is commonly used for simple, displaced olecranon fractures, it is associated with complications such as hardware prominence. To date, studies comparing between the efficacy and safety of TBW and plate fixation for these fractures have not provided a conclusive answer.\n\nPurposes: To investigate which of the two techniques provide better functional and radiological outcomes for simple displaced Mayo type 2A olecranon fractures, Which technique provides better patient-reported outcomes, What are the complication rates associated with each technique', 'detailedDescription': 'Background: While the tension band wiring (TBW) technique is commonly used for simple, displaced olecranon fractures, it is associated with complications such as hardware prominence. To date, studies comparing between the efficacy and safety of TBW and plate fixation for these fractures have not provided a conclusive answer.\n\nPurposes: To investigate which of the two techniques provide better functional and radiological outcomes for simple displaced Mayo type 2A olecranon fractures, Which technique provides better patient-reported outcomes, What are the complication rates associated with each technique Methods: A long-term, prospective, randomized study on 50 adult patients who underwent surgery to treat acute, simple, displaced olecranon fractures in a Hand and Upper Extremity Surgery Unit at a tertiary care center between November 2012 and October 2017. Patients were randomized on a 1:1 basis to either tension band or plate fixation and were evaluated at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery. Evaluation of long-term complications continued after 1 year as clinically indicated. The primary outcome measure was the 1-year postoperative Disabilities of the Arm, Shoulder and Hand (DASH) score. Additional outcome measures included patient-reported Oxford elbow score, functional (i.e., range of motion) and radiographic assessments and complication rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. traumatic non-pathological simple olecranon fracture\n2. age 18 years or older\n3. presentation within 2 weeks of injury.\n\nExclusion Criteria:\n\n1. inability to sign an informed consent\n2. inability to comply with follow-up\n3. associated elbow fractures\n4. open fractures\n5. pregnancy.'}, 'identificationModule': {'nctId': 'NCT05754320', 'briefTitle': 'TBW vs Plating in Olecranon Fractures', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Tension Band Wire Fixation Versus Plating for Simple Displaced Olecranon Fractures: A Long-Term Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '94/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tension Band Wire fixation', 'description': 'patients suffering simple olecranon fracture, randomized for treatment of tension band wire fixation', 'interventionNames': ['Device: Tension band wire fixation']}, {'type': 'EXPERIMENTAL', 'label': 'Plate fixation', 'description': 'patients suffering simple olecranon fracture, randomized for treatment of plate fixation', 'interventionNames': ['Device: Plate fixation']}], 'interventions': [{'name': 'Tension band wire fixation', 'type': 'DEVICE', 'description': 'Tension band wire fixation', 'armGroupLabels': ['Tension Band Wire fixation']}, {'name': 'Plate fixation', 'type': 'DEVICE', 'description': 'Tension band wire fixation', 'armGroupLabels': ['Plate fixation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Be’er Ya‘aqov', 'country': 'Israel', 'facility': 'Assaf Harofeh Medical Center (Yitzhak Shamir Medical Center)', 'geoPoint': {'lat': 31.93864, 'lon': 34.83749}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yonnatan Persitz', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}