Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-28 @ 7:14 AM
Study NCT ID:
NCT03189303
Status:
COMPLETED
Last Update Posted:
2022-02-15
First Post:
2017-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cup Position in THA With Standard Instruments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-11', 'studyFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2017-06-14', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite success of cup inclination and cup version.', 'timeFrame': '6 weeks', 'description': "The primary endpoint is acetabular cup position success at 6 weeks postoperatively. It is a composite endpoint; in order for an individual cup position to be considered successful, the cup's placement must satisfy all of the following criteria at 6 weeks:\n\n1. Inclination Success: within 10 degrees of the planned inclination\n2. Version Success: within 10 degrees of the planned version"}], 'secondaryOutcomes': [{'measure': 'Inclination success', 'timeFrame': '6 weeks', 'description': 'Inclination Success: within 10 degrees of the planned inclination'}, {'measure': 'Version success', 'timeFrame': '6 weeks', 'description': 'Version success: within 10 degrees of the planned version'}, {'measure': '90 day postoperative complication rates', 'timeFrame': '90 days postoperative', 'description': 'The number of subjects and the percentage of subjects with complications at 90 days post-operatively'}, {'measure': 'Harris Hip Score', 'timeFrame': 'Baseline and 6 and 12 weeks postoperative', 'description': 'Change from preoperative baseline for the Harris Hip Score'}, {'measure': 'Forgotten Joint Score', 'timeFrame': '6 and 12 weeks postoperative', 'description': 'Change from 6 week baseline for the Forgotten Joint Score'}, {'measure': 'EQ-5D-5L dimension score', 'timeFrame': 'Baseline and 6 and 12 weeks postoperative', 'description': 'Mean change from baseline for the specified time points'}, {'measure': 'EQ-VAS score (subscore of EQ-5D-5L)', 'timeFrame': 'Baseline and 6 and 12 weeks postoperative', 'description': 'Mean change from baseline for the specified time points'}, {'measure': 'EQ-5D-5L index value (if applicable)', 'timeFrame': 'Baseline and 6 and 12 weeks postoperative', 'description': 'Mean change from baseline for the specified time points'}, {'measure': 'Radiographic Outcomes', 'timeFrame': 'Baseline and 6 and 12 weeks postoperative', 'description': 'Radiographs will be read by an independent radiographic reviewer (IRR) at 6 weeks to act as a baseline measurement to be compared to radiographs taken at later time points (12 weeks). Parameters measured include subsidence, migration, inclination and version angles, osteolysis, and radiolucency.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '39061099', 'type': 'DERIVED', 'citation': 'Fawley D, Bernard T, Thomason HC 3rd, Zagra L, Ten Broeke RHM, Johnson K. Early functional recovery outcomes and return to work after primary total hip arthroplasty: a novel patient reported outcomes questionnaire. J Orthop Surg Res. 2024 Jul 26;19(1):434. doi: 10.1186/s13018-024-04937-z.'}, {'pmid': '38727945', 'type': 'DERIVED', 'citation': 'Meermans G, Fawley D, Zagra L, Ten Broeke RHM, Johnson K, Bernard T, Thomason HC 3rd. Accuracy of cup placement compared with preoperative surgeon targets in primary total hip arthroplasty using standard instrumentation and techniques: a global, multicenter study. J Orthop Traumatol. 2024 May 10;25(1):25. doi: 10.1186/s10195-024-00766-2.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6 and 12 weeks postoperatively.', 'detailedDescription': 'This is a global, prospective, multi-center study with a planned analysis of a minimum of 176 Subjects. Up to 15 study sites will participate in this study. The primary and secondary endpoints are as follows:\n\nPrimary endpoint:\n\nThe primary endpoint is acetabular cup position success at 6 weeks postoperatively. Success is defined as cup inclination and version within 10 degrees of the plan.\n\nSecondary endpoints:\n\n1. Inclination success (as defined for the primary endpoint)\n2. Version success (as defined for the primary endpoint)\n3. 90-day complication rates\n4. Change from preoperative baseline for the Harris Hip Score\n5. Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Modified Lauenstein Lateral)\n6. Change from preoperative baseline for the EQ-5D-5L (health state, EQ-VAS, and index value, if applicable)\n7. Change from 6 week baseline for the Forgotten Joint Score'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who the investigator deems to be a candidate for a primary total hip arthroplasty (THA) using the study devices (Pinnacle cup with a Corail or Summit stem) in a primary uncemented THA.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. All devices are to be used according to the approved indications\n2. The patient is undergoing a standard of care hip replacement with the Pinnacle cup and a Corail, Summit, or Actis stem via the posterolateral, anterolateral, or direct lateral approach with the patient in the lateral decubitus position.\n3. Individuals who are able to speak, read, and comprehend the Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes.\n4. Individuals who are willing and able to complete follow-up as specified by the study protocol.\n5. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the study protocol.\n6. Individuals who are not bedridden.\n7. Individuals who are a minimum age of 21 years at the time of consent.\n\nExclusion Criteria:\n\n1. Active local or systemic infection.\n2. Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.\n3. Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).\n4. Charcot's or Paget's disease.\n5. The Subject is a woman who is pregnant or lactating.\n6. Subject had a contralateral amputation.\n7. Previous partial hip replacement in affected hip.\n8. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.\n9. Contralateral hip was replaced less than 6 months prior to surgery date\n10. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.\n11. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.\n12. Subject has a medical condition with less than 2 years of life expectancy.\n13. Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements."}, 'identificationModule': {'nctId': 'NCT03189303', 'briefTitle': 'Cup Position in THA With Standard Instruments', 'organization': {'class': 'INDUSTRY', 'fullName': 'DePuy Orthopaedics'}, 'officialTitle': 'Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Standard Instrumentation and Technique', 'orgStudyIdInfo': {'id': 'DSJ_15010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Primary Uncemented Total Hip Arthroplasty', 'type': 'DEVICE', 'description': 'The study devices are the Pinnacle Hip System acetabular cup with a Summit, Actis, or Corail femoral stem'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Orthopaedic Associates of Michigan', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28054', 'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Orthopaedic and Sports Medicine Center', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '43055', 'city': 'Newark', 'state': 'Ohio', 'country': 'United States', 'facility': 'Orthopedic Specialists and Sports Medicine', 'geoPoint': {'lat': 40.05812, 'lon': -82.40126}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Lowcountry Orthopaedics & Sports Medicine', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Orthopedico Galeazzi IRCCS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Bergen op Zoom', 'country': 'Netherlands', 'facility': 'Bravis Hospital', 'geoPoint': {'lat': 51.495, 'lon': 4.29167}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Canisius Wilhelmina Hospital', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Woodend Hospital', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'city': 'Rhyl', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Glan Clwyd Hospital', 'geoPoint': {'lat': 53.31929, 'lon': -3.49228}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DePuy Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}