Massachusetts General Hospital Evaluation of DePuy ASR Hip System
NCT ID: NCT01611233
Last Updated: 2021-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1950 participants
OBSERVATIONAL
2012-09-30
2022-12-31
Brief Summary
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* ASR XL Hip System
* 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.
The 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.
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Detailed Description
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* Adults who have previously undergone a surgery implanting the DePuy ASR XL Acetabular Hip System or ASR Hip Resurfacing System;
* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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DePuy ASR THA
Adults having received a Depuy ASR metal on metal hip system which is subject to a voluntary recall.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Able to provide informed consent previously approved by institution's Institutional Review board (IRB) or ethics committee (EC).
3. Able to return for follow-up.
4. Able to complete the required patient reported outcome measures.
Exclusion Criteria
2. Any patient who received the ASR-XL implant as a result of a hip resurfacing conversion or a revision THA.
3. Subjects with difficulty in comprehending the Informed Consent Form for any reason.
4. The subject refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, or the medical office staff.
21 Years
ALL
No
Sponsors
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Depuy, Inc.
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Orhun Muratoglu
Co-Director, Harris Orthopedics Laboratory
Principal Investigators
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Orhun Muratoglu, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Northshore University HealthSystem, Glenbrook Hospital
Glenview, Illinois, United States
Summit Orthopedics
Woodbury, Minnesota, United States
Syracuse Orthopedic Specialists
Syracuse, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Texas Hip and Knee Center
Fort Worth, Texas, United States
Sportsmed Sa
Stepney, South Australia, Australia
Istituti Ospedalieri Bresciani S.p.A.
Brescia, , Italy
Morningside Medi-Clinic
Bryanston, , South Africa
Cape Hip and Knee Practice
Cape Town, , South Africa
Westville Hospital
Durban, , South Africa
Royal Berkshire Hospital
Reading, Berkshire, United Kingdom
Rotherham NHS Foundation Trust, Rotherham Hospital
Rotherham, , United Kingdom
Sheffield Teaching Hospitals Foundation Trust
Sheffield, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2012P000554
Identifier Type: -
Identifier Source: org_study_id
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