Osteoarthritis
Conditions
Keywords
metal on metal, hip replacement, ASR, DePuy
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.
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.
Interventions
None listed
Sponsors
Depuy, Inc.
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival rate after hip arthroplasty using DePuy ASR/ASR-XL implants | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | To quantify incidence of adverse local tissue reaction due to metal debris released from the metal-on-metal ASR implant |
| 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) | To quantify the levels of cobalt and chromium ions in blood serum for patients with the ASR metal-on-metal implant |
| 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) | To measure component positioning and implant stability in patients with the ASR metal-on-metal implant |
| 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) | To quantify patient reported variables such as pain, activity, and function using validated questionnaires |
Countries
Australia, Italy, South Africa, United Kingdom, United States
Outcome results
None listed