Massachusetts General Hospital Evaluation of DePuy ASR Hip System

January 5, 2021 updated by: Orhun Muratoglu, Massachusetts General Hospital

Clinical Follow-up of ASR Patients Post-Recall

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Actual)

1950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Stepney, South Australia, Australia, 5069
        • Sportsmed Sa
  • Italy
      • Brescia, Italy, 25127
        • Istituti Ospedalieri Bresciani S.p.A.
  • South Africa
      • Bryanston, South Africa, 2021
        • Morningside Medi-Clinic
      • Cape Town, South Africa, 7708
        • Cape Hip and Knee Practice
      • Durban, South Africa, 3629
        • Westville Hospital
  • United Kingdom
      • Rotherham, United Kingdom, S60 2UD
        • Rotherham NHS Foundation Trust, Rotherham Hospital
      • Sheffield, United Kingdom, S10 2SE
        • Sheffield Teaching Hospitals Foundation Trust
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG1 5AN
        • Royal Berkshire Hospital
  • United States
    • Illinois
      • Glenview, Illinois, United States, 60201
        • Northshore University HealthSystem, Glenbrook Hospital
    • Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Summit Orthopedics
    • New York
      • Syracuse, New York, United States, 13214
        • Syracuse Orthopedic Specialists
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Texas Hip and Knee Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with DePuy ASR or ASR-XL hip implants

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
On the date of revision surgery, not later than the last, 5 year study follow-up visit (<= 6.5 years after enrollment)
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
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)
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
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)
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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Depuy, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

May 24, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (Estimate)

June 4, 2012

Study Record Updates

Last Update Posted (Actual)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012P000554

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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