NCT01611233

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,950

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
5 countries

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

9.6 years

First QC Date

May 24, 2012

Last Update Submit

January 5, 2021

Conditions

Osteoarthritis

Keywords

metal on metalhip replacementASRDePuy

Outcome Measures

Primary Outcomes (1)

  • Implant survival rate after hip arthroplasty using DePuy ASR/ASR-XL implants

    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 Outcomes (4)

  • Incidence of adverse local tissue reaction

    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

    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

    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

    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)

Study Arms (1)

DePuy ASR THA

Adults having received a Depuy ASR metal on metal hip system which is subject to a voluntary recall.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with DePuy ASR or ASR-XL hip implants

You may qualify if:

  • Any patient with on-label use of the ASR-XL or ASR component system currently implanted.
  • Able to provide informed consent previously approved by institution's Institutional Review board (IRB) or ethics committee (EC).
  • Able to return for follow-up.
  • Able to complete the required patient reported outcome measures.

You may not qualify if:

  • Any patient with off-label use indications for the ASR-XL or ASR component system.
  • Any patient who received the ASR-XL implant as a result of a hip resurfacing conversion or a revision THA.
  • Subjects with difficulty in comprehending the Informed Consent Form for any reason.
  • The subject refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, or the medical office staff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Northshore University HealthSystem, Glenbrook Hospital

Glenview, Illinois, 60201, United States

Location

Summit Orthopedics

Woodbury, Minnesota, 55125, United States

Location

Syracuse Orthopedic Specialists

Syracuse, New York, 13214, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Texas Hip and Knee Center

Fort Worth, Texas, 76104, United States

Location

Sportsmed Sa

Stepney, South Australia, 5069, Australia

Location

Istituti Ospedalieri Bresciani S.p.A.

Brescia, 25127, Italy

Location

Morningside Medi-Clinic

Bryanston, 2021, South Africa

Location

Cape Hip and Knee Practice

Cape Town, 7708, South Africa

Location

Westville Hospital

Durban, 3629, South Africa

Location

Royal Berkshire Hospital

Reading, Berkshire, RG1 5AN, United Kingdom

Location

Rotherham NHS Foundation Trust, Rotherham Hospital

Rotherham, S60 2UD, United Kingdom

Location

Sheffield Teaching Hospitals Foundation Trust

Sheffield, S10 2SE, United Kingdom

Location

Related Publications (9)

  • 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: 27121872BACKGROUND

  • 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: 26310677BACKGROUND

  • 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: 28947371BACKGROUND

  • 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: 27178012BACKGROUND

  • 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: 28363892BACKGROUND

  • 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: 28574125BACKGROUND

  • 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: 27852907BACKGROUND

  • 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: 26055146BACKGROUND

  • 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.

    PMID: 27459602BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Orhun Muratoglu, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director, Harris Orthopedics Laboratory

Study Record Dates

First Submitted

May 24, 2012

First Posted

June 4, 2012

Study Start

September 1, 2012

Primary Completion

April 1, 2022

Study Completion

December 1, 2022

Last Updated

January 7, 2021

Record last verified: 2021-01

Locations

GB(3)AU(1)IT(1)ZA(3)US(5)