Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-03-03 @ 3:03 PM
Study NCT ID:
NCT04092634
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2019-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual Mobility in "High Risk" Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006617', 'term': 'Hip Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial with two groups: THA with dual mobility components vs THA with single-bearing designs.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 412}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2035-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2019-09-11', 'studyFirstSubmitQcDate': '2019-09-13', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hip Dislocation', 'timeFrame': '6 weeks following their index surgical procedure.', 'description': 'The rate of prosthetic dislocation between the two cohorts'}, {'measure': 'Hip Dislocation', 'timeFrame': '1 year following their index surgical procedure.', 'description': 'The rate of prosthetic dislocation between the two cohorts'}, {'measure': 'Hip Dislocation', 'timeFrame': '2 years following their index surgical procedure.', 'description': 'The rate of prosthetic dislocation between the two cohorts'}, {'measure': 'Hip Dislocation', 'timeFrame': '5 years following their index surgical procedure.', 'description': 'The rate of prosthetic dislocation between the two cohorts'}, {'measure': 'Hip Dislocation', 'timeFrame': '10 years following their index surgical procedure.', 'description': 'The rate of prosthetic dislocation between the two cohorts'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'Complications will be assess up to 10 years following their index surgical procedure', 'description': 'Any peri- or postoperative complications will be recorded component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates'}, {'measure': 'Radiographic signs of loosening and proper component placement.', 'timeFrame': '6 weeks following their index surgical procedure.', 'description': 'Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. These radiographs will be assess for the presence of loosening in a yes/no format'}, {'measure': 'Radiographic signs of loosening and proper component placement.', 'timeFrame': '1 year following their index surgical procedure.', 'description': 'Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. These radiographs will be assess for the presence of loosening in a yes/no format'}, {'measure': 'Radiographic signs of loosening and proper component placement.', 'timeFrame': '2 years following their index surgical procedure.', 'description': 'Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. These radiographs will be assess for the presence of loosening in a yes/no format'}, {'measure': 'Radiographic signs of loosening and proper component placement.', 'timeFrame': '5 years following their index surgical procedure.', 'description': 'Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. These radiographs will be assess for the presence of loosening in a yes/no format'}, {'measure': 'Radiographic signs of loosening and proper component placement.', 'timeFrame': '10 years following their index surgical procedure.', 'description': 'Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. These radiographs will be assess for the presence of loosening in a yes/no format'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dislocation, Hip']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single bearing design.', 'detailedDescription': 'This study aims to compare the clinical outcomes of patients considered to be at high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single-bearing design.\n\nWe hypothesize that in primary THA patients considered to be at high risk for prosthetic dislocation, the use of dual-mobility components will be associated with a lower dislocation rate in the first year following the index procedure. We do not anticipate a difference. In other clinical outcome measures or functional outcome scores between the two cohorts.\n\nStudy Design: Randomized controlled trial with two groups: THA with dual mobility.\n\n44 components vs THA with single-bearing designs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Primary THA for a diagnosis of osteoarthritis or inflammatory arthritis in the setting of a history of prior lumbar or lumbosacral fusion performed at least 6 months prior to their THA. In addition, patients considered high-risk for potential prosthetic dislocation will be included based on the presence of one or more of the following: neuromuscular disorder (e.g. cerebral palsy, Parkinson's disease, history of a stroke), dementia or cognitive impairment, substance or alcohol abuse (\\>10 drinks per week), acute displaced femoral neck fracture, age \\> 75 years, inflammatory arthritis, and increased preoperative range of motion (calculated as described by Krenzel et al.: combined flexion, adduction, internal rotation \\> 115 degrees).\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Revision THA\n* spinopelvic fusion that is more recent than 6 months prior to THA\n* isolated cervical or thoracic fusion\n* intent to undergo a revision spinopelvic fusion within one year of their index THA\n* a history of prior infection in the affected hip\n* a history of prior open surgery on the affected hip (i.e. prior proximal femur fracture or osteotomy)\n* or a preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture"}, 'identificationModule': {'nctId': 'NCT04092634', 'briefTitle': 'Dual Mobility in "High Risk" Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Dual-mobility vs. Single-bearing Components in THA at "High Risk" for Prosthetic Dislocation', 'orgStudyIdInfo': {'id': '17030101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dual mobility', 'description': 'Patients in this group will receive a dual mobility hip implant', 'interventionNames': ['Device: Dual mobility implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single bearing, traditional hip implant', 'description': 'Patients in this group will receive a traditional, single-bearing hip implant.', 'interventionNames': ['Device: Traditional, Single-bearing hip implant']}], 'interventions': [{'name': 'Dual mobility implant', 'type': 'DEVICE', 'description': 'Patients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant', 'armGroupLabels': ['Dual mobility']}, {'name': 'Traditional, Single-bearing hip implant', 'type': 'DEVICE', 'description': 'Patients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant', 'armGroupLabels': ['Single bearing, traditional hip implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck School of Medicine of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'New York University', 'class': 'OTHER'}, {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, {'name': 'Keck School of Medicine of USC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}