Massachusetts General Hospital Evaluation of DePuy ASR Hip System
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|ClinicalTrials.gov Identifier: NCT01611233|
Recruitment Status : Unknown
Verified January 2021 by Orhun Muratoglu, Massachusetts General Hospital.
Recruitment status was: Active, not recruiting
First Posted : June 4, 2012
Last Update Posted : January 7, 2021
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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.
|Condition or disease|
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|
|Actual Enrollment :||1950 participants|
|Official Title:||Clinical Follow-up of ASR Patients Post-Recall|
|Actual Study Start Date :||September 2012|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||December 2022|
DePuy ASR THA
Adults having received a Depuy ASR metal on metal hip system which is subject to a voluntary recall.
- 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
- 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
- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611233
|United States, Illinois|
|Northshore University HealthSystem, Glenbrook Hospital|
|Glenview, Illinois, United States, 60201|
|United States, Minnesota|
|Woodbury, Minnesota, United States, 55125|
|United States, New York|
|Syracuse Orthopedic Specialists|
|Syracuse, New York, United States, 13214|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|Texas Hip and Knee Center|
|Fort Worth, Texas, United States, 76104|
|Australia, South Australia|
|Stepney, South Australia, Australia, 5069|
|Istituti Ospedalieri Bresciani S.p.A.|
|Brescia, Italy, 25127|
|Bryanston, South Africa, 2021|
|Cape Hip and Knee Practice|
|Cape Town, South Africa, 7708|
|Durban, South Africa, 3629|
|Royal Berkshire Hospital|
|Reading, Berkshire, United Kingdom, RG1 5AN|
|Rotherham NHS Foundation Trust, Rotherham Hospital|
|Rotherham, United Kingdom, S60 2UD|
|Sheffield Teaching Hospitals Foundation Trust|
|Sheffield, United Kingdom, S10 2SE|
|Principal Investigator:||Orhun Muratoglu, PhD||Massachusetts General Hospital|
|Responsible Party:||Orhun Muratoglu, Co-Director, Harris Orthopedics Laboratory, Massachusetts General Hospital|
|Other Study ID Numbers:||
|First Posted:||June 4, 2012 Key Record Dates|
|Last Update Posted:||January 7, 2021|
|Last Verified:||January 2021|
metal on metal