Massachusetts General Hospital Evaluation of DePuy ASR Hip System

Osteoarthritis Clinical Trial

Official title:

Clinical Follow-up of ASR Patients Post-Recall

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01611233
• Other study ID #: 2012P000554
• Status: Active, not recruiting
• Start date: September 2012
• Est. completion date: December 2022

Study information

• Verified date: January 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1950
• Est. completion date: December 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
Australia	Sportsmed Sa	Stepney	South Australia
Italy	Istituti Ospedalieri Bresciani S.p.A.	Brescia
South Africa	Morningside Medi-Clinic	Bryanston
South Africa	Cape Hip and Knee Practice	Cape Town
South Africa	Westville Hospital	Durban
United Kingdom	Royal Berkshire Hospital	Reading	Berkshire
United Kingdom	Rotherham NHS Foundation Trust, Rotherham Hospital	Rotherham
United Kingdom	Sheffield Teaching Hospitals Foundation Trust	Sheffield
United States	Duke University Medical Center	Durham	North Carolina
United States	Texas Hip and Knee Center	Fort Worth	Texas
United States	Northshore University HealthSystem, Glenbrook Hospital	Glenview	Illinois
United States	Syracuse Orthopedic Specialists	Syracuse	New York
United States	Summit Orthopedics	Woodbury	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Depuy, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Italy,  South Africa,  United Kingdom, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of adverse local tissue reaction	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)
Secondary	Cobalt and Chromium ion levels in serum	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)
Secondary	Plain radiographic, ultrasound and/or MRI evaluation	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)
Secondary	Patient reported outcome scores: UCLA, Harris Hip, Case Mix Indicator and EQ-5D	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)