Clinical trial NCT01611233: Massachusetts General Hospital Evaluation of DePuy ASR Hip System
Official title: Clinical Follow-up of ASR Patients Post-Recall
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Keywords: metal on metal
hip replacement
ASR
DePuy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Depuy, Inc.
First posted: 2012-06-04
Enrollment: 1950
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with DePuy ASR or ASR-XL hip implants

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implant survival rate after hip arthroplasty using DePuy ASR/ASR-XL implants
timeFrame: 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 outcomes:
measure: Incidence of adverse local tissue reaction
timeFrame: On the date of revision surgery, not later than the last, 5 year study follow-up visit (<= 6.5 years after enrollment)
measure: Cobalt and Chromium ion levels in serum
timeFrame: 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)
measure: Plain radiographic, ultrasound and/or MRI evaluation
timeFrame: 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)
measure: Patient reported outcome scores: UCLA, Harris Hip, Case Mix Indicator and EQ-5D
timeFrame: 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)
Other outcomes:
Locations:
city: Glenview
country: United States
facility: Northshore University HealthSystem, Glenbrook Hospital
state: Illinois
city: Woodbury
country: United States
facility: Summit Orthopedics
state: Minnesota
city: Syracuse
country: United States
facility: Syracuse Orthopedic Specialists
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Fort Worth
country: United States
facility: Texas Hip and Knee Center
state: Texas
city: Stepney
country: Australia
facility: Sportsmed Sa
state: South Australia
city: Brescia
country: Italy
facility: Istituti Ospedalieri Bresciani S.p.A.
city: Bryanston
country: South Africa
facility: Morningside Medi-Clinic
city: Cape Town
country: South Africa
facility: Cape Hip and Knee Practice
city: Durban
country: South Africa
facility: Westville Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire Hospital
state: Berkshire
city: Rotherham
country: United Kingdom
facility: Rotherham NHS Foundation Trust, Rotherham Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals Foundation Trust
Study officials:
affiliation: Massachusetts General Hospital
name: Orhun Muratoglu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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. doi: 10.2106/JBJS.15.00685.
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.
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.