Massachusetts General Hospital Evaluation of DePuy ASR Hip System

• ClinicalTrials.gov Identifier: NCT01611233
• Recruitment Status: Unknown
• First Posted: June 4, 2012
• Last Update Posted: January 7, 2021
• Sponsor: Massachusetts General Hospital
• Collaborator: Depuy, Inc.
• Information provided by (Responsible Party): Orhun Muratoglu, Massachusetts General Hospital

Study Description

Brief Summary:

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:

• 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.

Condition or disease
Osteoarthritis

Detailed Description:

Description of the Subject Population:

• 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1950 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Follow-up of ASR Patients Post-Recall
• Actual Study Start Date: September 2012
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: December 2022

Groups and Cohorts

Group/Cohort
DePuy ASR THA; Adults having received a Depuy ASR metal on metal hip system which is subject to a voluntary recall.

Outcome Measures

Primary Outcome Measures :

1. Implant survival rate after hip arthroplasty using DePuy ASR/ASR-XL implants [ Time Frame: 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. ]
   To quantify implant failure rates following voluntary recall of the ASR implant

Secondary Outcome Measures :

1. Incidence of adverse local tissue reaction [ Time Frame: On the date of revision surgery, not later than the last, 5 year study follow-up visit (<= 6.5 years after enrollment) ]
   To quantify incidence of adverse local tissue reaction due to metal debris released from the metal-on-metal ASR implant
2. Cobalt and Chromium ion levels in serum [ Time Frame: 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) ]
   To quantify the levels of cobalt and chromium ions in blood serum for patients with the ASR metal-on-metal implant
3. Plain radiographic, ultrasound and/or MRI evaluation [ Time Frame: 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) ]
   To measure component positioning and implant stability in patients with the ASR metal-on-metal implant
4. Patient reported outcome scores: UCLA, Harris Hip, Case Mix Indicator and EQ-5D [ Time Frame: 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) ]
   To quantify patient reported variables such as pain, activity, and function using validated questionnaires

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with DePuy ASR or ASR-XL hip implants

Criteria

Inclusion Criteria

1. Any patient with on-label use of the ASR-XL or ASR component system currently implanted.
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

1. Any patient with off-label use indications for the ASR-XL or ASR component system.
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.

Contacts and Locations

Locations

United States, Illinois

Northshore University HealthSystem, Glenbrook Hospital

Glenview, Illinois, United States, 60201

United States, Minnesota

Summit Orthopedics

Woodbury, Minnesota, United States, 55125

United States, New York

Syracuse Orthopedic Specialists

Syracuse, New York, United States, 13214

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

United States, Texas

Texas Hip and Knee Center

Fort Worth, Texas, United States, 76104

Australia, South Australia

Sportsmed Sa

Stepney, South Australia, Australia, 5069

Italy

Istituti Ospedalieri Bresciani S.p.A.

Brescia, Italy, 25127

South Africa

Morningside Medi-Clinic

Bryanston, South Africa, 2021

Cape Hip and Knee Practice

Cape Town, South Africa, 7708

Westville Hospital

Durban, South Africa, 3629

United Kingdom

Royal Berkshire Hospital

Reading, Berkshire, United Kingdom, RG1 5AN

Rotherham NHS Foundation Trust, Rotherham Hospital

Rotherham, United Kingdom, S60 2UD

Sheffield Teaching Hospitals Foundation Trust

Sheffield, United Kingdom, S10 2SE

Sponsors and Collaborators

Massachusetts General Hospital

Depuy, Inc.

Investigators

• Principal Investigator: Orhun Muratoglu, PhD; Massachusetts General Hospital

More Information

Publications:

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.

• Responsible Party: Orhun Muratoglu, Co-Director, Harris Orthopedics Laboratory, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01611233
• Other Study ID Numbers: 2012P000554
• First Posted: June 4, 2012
• Last Update Posted: January 7, 2021
• Last Verified: January 2021

Keywords provided by Orhun Muratoglu, Massachusetts General Hospital:

metal on metal; hip replacement; ASR; DePuy

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases