Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Depuy, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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 of the Subject Population:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DePuy ASR THA | Adults having received a Depuy ASR metal on metal hip system which is subject to a voluntary recall. |
Not provided
| 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. |
| 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 |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Adult patients with DePuy ASR or ASR-XL hip implants
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Orhun Muratoglu, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northshore University HealthSystem, Glenbrook Hospital | Glenview | Illinois | 60201 | United States | ||
| Summit Orthopedics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27121872 | Background | 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. | |
| 26310677 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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) |
| Woodbury |
| Minnesota |
| 55125 |
| United States |
| Syracuse Orthopedic Specialists | Syracuse | New York | 13214 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Texas Hip and Knee Center | Fort Worth | Texas | 76104 | United States |
| Sportsmed Sa | Stepney | South Australia | 5069 | Australia |
| Istituti Ospedalieri Bresciani S.p.A. | Brescia | 25127 | Italy |
| Morningside Medi-Clinic | Bryanston | 2021 | South Africa |
| Cape Hip and Knee Practice | Cape Town | 7708 | South Africa |
| Westville Hospital | Durban | 3629 | South Africa |
| Royal Berkshire Hospital | Reading | Berkshire | RG1 5AN | United Kingdom |
| Rotherham NHS Foundation Trust, Rotherham Hospital | Rotherham | S60 2UD | United Kingdom |
| Sheffield Teaching Hospitals Foundation Trust | Sheffield | S10 2SE | United Kingdom |
| 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. |
| 28947371 | Background | 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. |
| 27178012 | Background | 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. |
| 28363892 | Background | 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. |
| 28574125 | Background | 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. |
| 27852907 | Background | 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. |
| 26055146 | Background | 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. |
| 27459602 | Background | 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. |