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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01611233




Registration number
NCT01611233
Ethics application status
Date submitted
24/05/2012
Date registered
4/06/2012
Date last updated
7/01/2021

Titles & IDs
Public title
Massachusetts General Hospital Evaluation of DePuy ASR Hip System
Scientific title
Clinical Follow-up of ASR Patients Post-Recall
Secondary ID [1] 0 0
2012P000554
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
DePuy ASR THA - Adults having received a Depuy ASR metal on metal hip system which is subject to a voluntary recall.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Implant survival rate after hip arthroplasty using DePuy ASR/ASR-XL implants
Timepoint [1] 0 0
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 [1] 0 0
Incidence of adverse local tissue reaction
Timepoint [1] 0 0
On the date of revision surgery, not later than the last, 5 year study follow-up visit (<= 6.5 years after enrollment)
Secondary outcome [2] 0 0
Cobalt and Chromium ion levels in serum
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Plain radiographic, ultrasound and/or MRI evaluation
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Patient reported outcome scores: UCLA, Harris Hip, Case Mix Indicator and EQ-5D
Timepoint [4] 0 0
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)

Eligibility
Key inclusion 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.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
Accrual to date
Final
1950
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Sportsmed Sa - Stepney
Recruitment postcode(s) [1] 0 0
5069 - Stepney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Italy
State/province [6] 0 0
Brescia
Country [7] 0 0
South Africa
State/province [7] 0 0
Bryanston
Country [8] 0 0
South Africa
State/province [8] 0 0
Cape Town
Country [9] 0 0
South Africa
State/province [9] 0 0
Durban
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Berkshire
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Rotherham
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Other
Name
Massachusetts General Hospital
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Depuy, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01611233
Trial related presentations / publications
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.
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.
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.
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.
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Orhun Muratoglu, PhD
Address 0 0
Massachusetts General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01611233