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Massachusetts General Hospital Evaluation of DePuy ASR Hip System

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ClinicalTrials.gov Identifier: NCT01611233
Recruitment Status : Active, not recruiting
First Posted : June 4, 2012
Last Update Posted : January 7, 2021
Sponsor:
Collaborator:
Depuy, Inc.
Information provided by (Responsible Party):
Orhun Muratoglu, Massachusetts General Hospital

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.

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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

Resource links provided by the National Library of Medicine


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



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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611233


Locations
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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
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Principal Investigator: Orhun Muratoglu, PhD Massachusetts General Hospital
Publications:

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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    Key Record Dates
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:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases