Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-01-01 @ 5:15 AM
Study NCT ID:
NCT01611233
Status:
UNKNOWN
Last Update Posted:
2021-01-07
First Post:
2012-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Massachusetts General Hospital Evaluation of DePuy ASR Hip System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1950}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2012-05-24', 'studyFirstSubmitQcDate': '2012-05-31', 'lastUpdatePostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant survival rate after hip arthroplasty using DePuy ASR/ASR-XL implants', 'timeFrame': 'From the date of primary hip replacement surgery to the end of the study (up to 6 (+/- 0.5) years after enrollment) or to the date of revision surgery, whichever event occurs first.', 'description': 'To quantify implant failure rates following voluntary recall of the ASR implant'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse local tissue reaction', 'timeFrame': 'On the date of revision surgery, not later than the last, 5 year study follow-up visit (<= 6.5 years after enrollment)', 'description': 'To quantify incidence of adverse local tissue reaction due to metal debris released from the metal-on-metal ASR implant'}, {'measure': 'Cobalt and Chromium ion levels in serum', 'timeFrame': 'Within 24 months before enrollment, at each annual follow-up visit; within 6 months before and then within 6 months after revision surgery (last test results <= 7 years after enrollment date)', 'description': 'To quantify the levels of cobalt and chromium ions in blood serum for patients with the ASR metal-on-metal implant'}, {'measure': 'Plain radiographic, ultrasound and/or MRI evaluation', 'timeFrame': 'Within 24 months before enrollment, each annual follow-up visit and within 6 months before revision surgery (last images results <= 6.5 years after enrollment date)', 'description': 'To measure component positioning and implant stability in patients with the ASR metal-on-metal implant'}, {'measure': 'Patient reported outcome scores: UCLA, Harris Hip, Case Mix Indicator and EQ-5D', 'timeFrame': 'At enrollment and each of the 5 annual follow-up visits ((last surveys <= 6.5 years after enrollment date, unless there is revision surgery, then at the last annual follow-up visit)', 'description': 'To quantify patient reported variables such as pain, activity, and function using validated questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metal on metal', 'hip replacement', 'ASR', 'DePuy'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '27121872', 'type': 'BACKGROUND', 'citation': 'Donahue GS, Lindgren V, Galea VP, Madanat R, Muratoglu O, Malchau H. Are Females at Greater Risk for Revision Surgery After Hip Resurfacing Arthroplasty With the Articular Surface Replacement Prosthesis? Clin Orthop Relat Res. 2016 Oct;474(10):2257-65. doi: 10.1007/s11999-016-4860-x. Epub 2016 Apr 27.'}, {'pmid': '26310677', 'type': 'BACKGROUND', 'citation': 'Madanat R, Hussey DK, Donahue GS, Potter HG, Wallace R, Bragdon C, Muratoglu O, Malchau H. Early Lessons From a Worldwide, Multicenter, Followup Study of the Recalled Articular Surface Replacement Hip System. Clin Orthop Relat Res. 2016 Jan;474(1):166-74. doi: 10.1007/s11999-015-4456-x. Epub 2015 Aug 27.'}, {'pmid': '28947371', 'type': 'BACKGROUND', 'citation': 'Laaksonen I, Galea VP, Connelly JW, Matuszak SJ, Muratoglu OK, Malchau H. Inferior Radiographic and Functional Outcomes With Modular Stem in Metal-on-Metal Total Hip Arthroplasty. J Arthroplasty. 2018 Feb;33(2):464-469. doi: 10.1016/j.arth.2017.08.042. Epub 2017 Sep 6.'}, {'pmid': '27178012', 'type': 'BACKGROUND', 'citation': 'Madanat R, Rolfson O, Donahue GS, Hussey DK, Potter HG, Wallace R, Muratoglu OK, Malchau H. Medial Calcar Erosion Is Associated With Synovial Thickness in Patients With ASR XL Total Hip Arthroplasty. J Arthroplasty. 2016 Nov;31(11):2588-2592. doi: 10.1016/j.arth.2016.04.005. Epub 2016 Apr 13.'}, {'pmid': '28363892', 'type': 'BACKGROUND', 'citation': 'Galea VP, Laaksonen I, Matuszak SJ, Connelly JW, Muratoglu O, Malchau H. Mid-term changes in blood metal ion levels after Articular Surface Replacement arthroplasty of the hip. Bone Joint J. 2017 Apr;99-B(4 Supple B):33-40. doi: 10.1302/0301-620X.99B4.BJJ-2016-1250.R1.'}, {'pmid': '28574125', 'type': 'BACKGROUND', 'citation': 'Donahue GS, Lindgren V, Galea VP, Madanat R, Muratoglu OK, Malchau H. Risk factors for mid-term revision surgery in patients with articular surface replacement total hip arthroplasty. Hip Int. 2018 Jan;28(1):44-49. doi: 10.5301/hipint.5000524.'}, {'pmid': '27852907', 'type': 'BACKGROUND', 'citation': 'Hussey DK, Madanat R, Donahue GS, Rolfson O, Bragdon CR, Muratoglu OK, Malchau H. Scoring the Current Risk Stratification Guidelines in Follow-up Evaluation of Patients After Metal-on-Metal Hip Arthroplasty: A Proposal for a Metal-on-Metal Risk Score Supporting Clinical Decision-Making. J Bone Joint Surg Am. 2016 Nov 16;98(22):1905-1912. doi: 10.2106/JBJS.15.00685.'}, {'pmid': '26055146', 'type': 'BACKGROUND', 'citation': 'Madanat R, Hussey DK, Donahue GS, Potter HG, Wallace R, Bragdon CR, Muratoglu OK, Malchau H. The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement. J Arthroplasty. 2015 Oct;30(10):1794-8. doi: 10.1016/j.arth.2015.04.036. Epub 2015 May 30.'}, {'pmid': '27459602', 'type': 'BACKGROUND', 'citation': 'Hussey DK, Madanat R, Donahue GS, Rolfson O, Muratoglu OK, Malchau H. Worse health-related quality of life and hip function in female patients with elevated chromium levels. Acta Orthop. 2016 Oct;87(5):485-91. doi: 10.1080/17453674.2016.1213596. Epub 2016 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'DePuy Orthopaedics has issued a voluntary recall of the ASR hip replacement system due to a higher than expected revision rate reported in the England/Wales and Australian national joint registries. There are two types of ASR hip implants used for total hip replacement surgery:\n\n* ASR XL Hip System\n* ASR Hip Resurfacing System Massachusetts General Hospital (MGH) in Boston, USA is the study sponsor. MGH is conducting this study with the help of funding from DePuy Orthopaedics. MGH will collect and analyze clinical information from 5,000 subjects around the world. The countries include the United States of America, Australia, South Africa, England, Denmark, Finland and Sweden. MGH will collect and analyze blood test results, X-rays, soft tissue imaging and how well the ASR hips are functioning. MGH will analyze the data annually for 6 years.\n\nThe purpose of this study is to follow patients who have the ASR hip system for the next 6 years. The findings of this study may help surgeons to make better informed decisions about monitoring and treatment of patients with ASR hip systems.', 'detailedDescription': 'Description of the Subject Population:\n\n* Adults who have previously undergone a surgery implanting the DePuy ASR XL Acetabular Hip System or ASR Hip Resurfacing System;\n* ASR patients who are already being followed-up by their surgeon at least once a year. This routine follow-up care consists of a clinic visit, blood tests, X-rays and possibly an MRI, Ultrasound or CT scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with DePuy ASR or ASR-XL hip implants', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Any patient with on-label use of the ASR-XL or ASR component system currently implanted.\n2. Able to provide informed consent previously approved by institution's Institutional Review board (IRB) or ethics committee (EC).\n3. Able to return for follow-up.\n4. Able to complete the required patient reported outcome measures.\n\nExclusion Criteria\n\n1. Any patient with off-label use indications for the ASR-XL or ASR component system.\n2. Any patient who received the ASR-XL implant as a result of a hip resurfacing conversion or a revision THA.\n3. Subjects with difficulty in comprehending the Informed Consent Form for any reason.\n4. The subject refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, or the medical office staff."}, 'identificationModule': {'nctId': 'NCT01611233', 'briefTitle': 'Massachusetts General Hospital Evaluation of DePuy ASR Hip System', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Clinical Follow-up of ASR Patients Post-Recall', 'orgStudyIdInfo': {'id': '2012P000554'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DePuy ASR THA', 'description': 'Adults having received a Depuy ASR metal on metal hip system which is subject to a voluntary recall.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60201', 'city': 'Glenview', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northshore University HealthSystem, Glenbrook Hospital', 'geoPoint': {'lat': 42.06975, 'lon': -87.78784}}, {'zip': '55125', 'city': 'Woodbury', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Summit Orthopedics', 'geoPoint': {'lat': 44.92386, 'lon': -92.95938}}, {'zip': '13214', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Syracuse Orthopedic Specialists', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Hip and Knee Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '5069', 'city': 'Stepney', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Sportsmed Sa', 'geoPoint': {'lat': -34.91229, 'lon': 138.62924}}, {'zip': '25127', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Istituti Ospedalieri Bresciani S.p.A.', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '2021', 'city': 'Bryanston', 'country': 'South Africa', 'facility': 'Morningside Medi-Clinic', 'geoPoint': {'lat': -26.05211, 'lon': 28.02805}}, {'zip': '7708', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Cape Hip and Knee Practice', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '3629', 'city': 'Durban', 'country': 'South Africa', 'facility': 'Westville Hospital', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': 'RG1 5AN', 'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'facility': 'Royal Berkshire Hospital', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'S60 2UD', 'city': 'Rotherham', 'country': 'United Kingdom', 'facility': 'Rotherham NHS Foundation Trust, Rotherham Hospital', 'geoPoint': {'lat': 53.43012, 'lon': -1.35678}}, {'zip': 'S10 2SE', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals Foundation Trust', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Orhun Muratoglu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Depuy, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Director, Harris Orthopedics Laboratory', 'investigatorFullName': 'Orhun Muratoglu', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}