Massachusetts General Hospital Evaluation of DePuy ASR Hip System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Follow-up of ASR Patients Post-Recall

Conditions
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Osteoarthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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. Exclusion Criteria 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DePuy ASR THA<br>Adults having received a Depuy ASR metal on metal hip system which is subject to a voluntary recall. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metal on metal, hip replacement, ASR, DePuy