OsteoarthritisNCT01611233
Massachusetts General Hospital Evaluation of DePuy ASR Hip System
An observational study of Osteoarthritis, run by Massachusetts General Hospital at 13 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis
- How many people
- 1,950 participants
- Where
- 13 sitesin 5 countries
- Study dates
- Sep 2012to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with DePuy ASR or ASR-XL hip implants
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
United States5 sites
Duke University Medical Center
Durham, North Carolina, 27710
Texas Hip and Knee Center
Fort Worth, Texas, 76104
Northshore University HealthSystem, Glenbrook Hospital
Glenview, Illinois, 60201
Syracuse Orthopedic Specialists
Syracuse, New York, 13214
Summit Orthopedics
Woodbury, Minnesota, 55125
South Africa3 sites
Morningside Medi-Clinic
Bryanston, 2021
Cape Hip and Knee Practice
Cape Town, 7708
Westville Hospital
Durban, 3629
United Kingdom3 sites
Royal Berkshire Hospital
Reading, Berkshire, RG1 5AN
Rotherham NHS Foundation Trust, Rotherham Hospital
Rotherham, S60 2UD
Sheffield Teaching Hospitals Foundation Trust
Sheffield, S10 2SE
About this study
Official title: Clinical Follow-up of ASR Patients Post-Recall
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.
Read the 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.
- Conditions
- Osteoarthritis
- Keywords
- metal on metal, hip replacement, ASR, DePuy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DePuy ASR THA | Adults having received a Depuy ASR metal on metal hip system which is subject to a voluntary recall. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival rate after hip arthroplasty using DePuy ASR/ASR-XL implants
To quantify implant failure rates following voluntary recall of the ASR implant
Measured: 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 (4)
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
Measured: 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
To quantify the levels of cobalt and chromium ions in blood serum for patients with the ASR metal-on-metal implant
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Depuy, Inc.
- Responsible party
- Principal investigator, Orhun Muratoglu, Massachusetts General Hospital
- Investigators
- Orhun Muratoglu, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611233
- Sponsor's protocol ID
- 2012P000554
- Status last verified
- Jan 2021
- First submitted
- 24 May 2012
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27121872Madanat 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.
PubMed 26310677Laaksonen 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.
PubMed 28947371Madanat 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.
PubMed 27178012Galea 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.
PubMed 28363892Donahue 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.
PubMed 28574125Hussey 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.
PubMed 27852907Madanat 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.
PubMed 26055146Hussey 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.
PubMed 27459602
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Follow-up of ASR Patients Post-Recall
- ClinicalTrials.gov ID
- NCT01611233
- Acronym / sponsor ID
- 2012P000554
- Conditions
- Osteoarthritis
- Keywords
- metal on metal, hip replacement, ASR, DePuy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,950 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Depuy, Inc.
- Study start
- Sep 2012 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DePuy ASR THA | – | –Adults having received a Depuy ASR metal on metal hip system which is subject to a voluntary recall. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with DePuy ASR or ASR-XL hip implants
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Background: PubMed 27121872Donahue 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.
- Background: PubMed 26310677Madanat 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.
- Background: PubMed 28947371Laaksonen 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.
- Background: PubMed 27178012Madanat 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.
- Background: PubMed 28363892Galea 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.
- Background: PubMed 28574125Donahue 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.
- Background: PubMed 27852907Hussey 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.
- Background: PubMed 26055146Madanat 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.
- Background: PubMed 27459602Hussey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orhun Muratoglu, PhD principal investigator
Massachusetts General Hospital
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Massachusetts General Hospital at 13 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, South Africa, United Kingdom, Australia, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01611233, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.