Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-31 @ 8:50 PM
Study NCT ID:
NCT01548456
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2012-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nails Versus Plates for Femur Fractures in Dar es Salaam, Tanzania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005594', 'term': 'Fracture Fixation, Intramedullary'}], 'ancestors': [{'id': 'D005593', 'term': 'Fracture Fixation, Internal'}, {'id': 'D005592', 'term': 'Fracture Fixation'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 332}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-16', 'studyFirstSubmitDate': '2012-02-27', 'studyFirstSubmitQcDate': '2012-03-05', 'lastUpdatePostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reoperation', 'timeFrame': '1-year', 'description': 'Reoperation involving the affected femur for any reason within the first year will be considered an event.'}], 'secondaryOutcomes': [{'measure': 'Health-related quality of life', 'timeFrame': '1-year', 'description': 'Health-related quality of life as measured by the EQ-5D-3L (Swahili version) by the Euroqol Group'}, {'measure': 'Return to work', 'timeFrame': '1-year', 'description': 'Time from surgery to return to work among patients employed at the time of injury'}, {'measure': 'Clinical union', 'timeFrame': '1-year', 'description': 'Defined as full painless weight bearing on the affected extremity'}, {'measure': 'Radiographic Union', 'timeFrame': '1-year', 'description': 'Bony healing as measured by the Radiographic Union Scale in Tibial Fractures (RUST) Score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['femur fracture', 'internal fixation', 'intramedullary nailing'], 'conditions': ['Femoral Fractures']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational study of patients with femur fractures in Dar es Salaam, Tanzania comparing two different surgical techniques: intramedullary nailing (IMN) and open reduction internal fixation (ORIF) with a plate. The primary outcome is the rate of reoperation for any reason, and the secondary outcomes are fracture healing, return to work, and health-related quality-of-life. The investigators hypothesize that there will be a difference in the rate of reoperation for patients with femur fractures treated with an IMN compared to ORIF with a plate.', 'detailedDescription': 'The study will be a prospective clinical trial conducted at Muhimbili Orthopaedic Institute (MOI) in Dar es Salaam, Tanzania. All adult patients with diaphyseal femur fractures meeting the eligibility criteria will be invited to enroll. Study subjects will be treated at the discretion of the surgeons at MOI. This could include an intramedullary nail, a plate, external fixation, or skeletal traction. Potential confounders recorded will be age, gender, body mass index, comorbidities, fracture pattern, open versus closed injury, time from injury to presentation, time from presentation to surgery, and associated injuries. The primary outcome considered will be reoperation for any reason. Secondary outcomes will be clinical union, defined as full-painless weight bearing on the injured extremity, radiographic union, return to work, and health-related quality-of-life. Follow up will be scheduled at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery and will include both clinical and radiographic evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with diaphyseal fractures of the femur presenting to Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania will be considered eligible for enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diaphyseal fracture amenable to operative fixation with an intramedullary nail or plate\n2. Age 18 to 65\n\nExclusion Criteria:\n\n1. Clinical evidence of infection at the surgical site (defined clinically as drainage or erythema)\n2. Pathologic fracture\n3. Prior surgery\n4. Presentation 3 weeks or more after injury\n5. Inability or unwillingness to comply with follow up to 1-year'}, 'identificationModule': {'nctId': 'NCT01548456', 'briefTitle': 'Nails Versus Plates for Femur Fractures in Dar es Salaam, Tanzania', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Intramedullary Nailing Versus Plates for Femoral Shaft Fractures in Dar es Salaam, Tanzania With Minimum 1-Year Follow-up', 'orgStudyIdInfo': {'id': 'UCSF 23346'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intramedullary nailing', 'description': 'Subjects with a femur fracture who undergo operative fixation with an intramedullary nail', 'interventionNames': ['Procedure: Intramedullary Nailing']}, {'label': 'Open Reduction Internal Fixation', 'description': 'Subjects with a femur fracture who undergo open reduction internal fixation with a dynamic compression plate', 'interventionNames': ['Procedure: Open Reduction Internal Fixation']}], 'interventions': [{'name': 'Intramedullary Nailing', 'type': 'PROCEDURE', 'otherNames': ['SIGN Intramedullary Nail'], 'description': 'Surgical treatment that includes closed or open reduction and stabilization of the femur fracture with an intramedullary rod inserted using antegrade or retrograde technique', 'armGroupLabels': ['Intramedullary nailing']}, {'name': 'Open Reduction Internal Fixation', 'type': 'PROCEDURE', 'description': 'Surgical treatment that includes open reduction internal fixation of the femur fracture with a dynamic compression plate', 'armGroupLabels': ['Open Reduction Internal Fixation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dar es Salaam', 'country': 'Tanzania', 'facility': 'Muhimbili Orthopaedic Institute', 'geoPoint': {'lat': -6.82349, 'lon': 39.26951}}], 'overallOfficials': [{'name': 'David W Shearer, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Edmund N Eliezer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Muhimbili Orthopaedic Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orthopaedic Research Foundation', 'class': 'OTHER'}, {'name': 'Orthopaedic Trauma Association', 'class': 'OTHER'}, {'name': 'Muhimbili Orthopaedic Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}