Rheumatoid ArthritisPhase 4NCT00872547
Multi-Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Resurfacing and Primary Total Hip Replacement
A Phase 4 study testing DePuy ASR™ Hip System and DePuy ASR™ XL Head / ASR™ Acetabular Cup System in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International at 8 sites in 8 countries.
Trial summary
The purpose of this study is to monitor the performance of a large metal-on-metal bearing from the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery or a total hip replacement. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis
- What is being tested?
- DePuy ASR™ Hip System and DePuy ASR™ XL Head / ASR™ Acetabular Cup System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Sep 2006to Nov 2011
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with primary osteoarthritis indicated for standard MoM hip resurfacing arthroplasty with cementless fixation in the acetabulum.
- Subjects whose bone morphology and bone quality mean that standard MoM hip resurfacing arthroplasty is not indicated, but for whom cementless fixation in the acetabulum and receipt of a large MoM bearing are still possible.
- General Exclusion Criteria:
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Subjects with compromised renal function defined as those whose measured values lie outside the normal range for a particular investigational site.
- Subjects with proven metal sensitivity.
Show all 19Show fewer
- Subjects with infectious, highly communicable diseases, which may limit follow-up i.e. Active tuberculosis, hepatitis, immuno-compromised conditions, etc.
- Women who are pregnant or who intend to become pregnant within 2 years of surgery.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
- Subjects who are currently, or have been in the last 12 months, participating in a clinical study which involves exposure to ionising radiation.
- Subjects who are currently involved in any injury litigation claims.
- Subjects who are undergoing corticosteroid treatment.
- Subjects with active or recent joint sepsis.
- Additional Exclusion Criteria for DePuy ASR™:
- Subjects with proven significant osteoporosis and poor bone quality.
- Subjects with marked atrophy or deformity in the upper femur, skeletal immaturity, or where loss of musculature or neuromuscular disease would render the procedure unjustifiable.
- Subjects whose anatomical CCD angle is below 120°.
- Subjects who have undergone irradiation of the affected hip.
Who cannot join
None listed.
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
Austria1 site
University Clinic for Orthopaedics and Orthopaedic Surgery - LKH
Graz
About this study
Official title: Prospective, International Multi-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of a Large Metal-on-Metal (MoM) Bearing Comprising a DePuy ASR™ Cup in Conjunction With Either a DePuy ASR™ Hip Resurfacing Femoral Component or a DePuy ASR™ XL Head in Subjects With Indications Suitable for Either a Primary Resurfacing Arthroplasty or Primary Total Hip Arthroplasty
The purpose of this study is to monitor the performance of a large metal-on-metal bearing from the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery or a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.
The Study was terminated with effect from 30th November 2011 following the completion of 2 year follow up assessments for those patients remaining in the study.
Please note that prior to this decision DePuy voluntarily recalled the ASR products on 24 August 2010. Additional information regarding this voluntary recall and the follow-up of patients affected by the recall can be found at the following links http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON155761 and http://www.depuy.com/countries_list.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Nonunion of Femoral Fractures
- Being tested
- DePuy ASR™ Hip System, DePuy ASR™ XL Head / ASR™ Acetabular Cup System
- Keywords
- Hip, Resurfacing, Metal-on-Metal, Large Heads, XL Head, ASR - osteoarthritis (primary)
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis, Collagen Diseases, Osteonecrosis, Hip Dislocation, Congenital, Slipped Capital Femoral Epiphyses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DePuy ASR™ Hip SystemDevice
Resurfacing system
DePuy ASR™ XL Head / ASR™ Acetabular Cup SystemDevice
Large Metal-on-Metal Total Hip Replacement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Resurfacing system Receives: Device: DePuy ASR™ Hip System |
| 2 | Active comparator | Large Metal-on-Metal Total Hip Replacement Receives: Device: DePuy ASR™ XL Head / ASR™ Acetabular Cup System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan-Meier survivorship calculated at the five-year time-point
Measured: 5yrs
Secondary outcomes (7)
Annual Kaplan-Meier survivorship calculations
Measured: Annually
Harris Hip Score
Measured: 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery
Radiographic analysis
Measured: 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery
Oxford Hip Score
Measured: 3mths, 6mths and annually post-surgery
UCLA Activity Score
Measured: 3mths, 6mths and annually post-surgery
Hip Outcome Score
Measured: 3mths, 6mths and annually post-surgery
EuroQol EQ-5D
Measured: 3mths, 6mths and annually post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startSep 2006
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: DePuy discontinued this product in 4Q2009. At the time of this decision DePuy reviewed all clinical studies for this product and decided to close this Study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872547
- Sponsor's protocol ID
- CT05/18
- Status last verified
- Jul 2016
- First submitted
- 30 Mar 2009
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, International Multi-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of a Large Metal-on-Metal (MoM) Bearing Comprising a DePuy ASR™ Cup in Conjunction With Either a DePuy ASR™ Hip Resurfacing Femoral Component or a DePuy ASR™ XL Head in Subjects With Indications Suitable for Either a Primary Resurfacing Arthroplasty or Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00872547
- Acronym / sponsor ID
- CT05/18
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Nonunion of Femoral Fractures
- Keywords
- Hip, Resurfacing, Metal-on-Metal, Large Heads, XL Head, ASR - osteoarthritis (primary)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DePuy discontinued this product in 4Q2009. At the time of this decision DePuy reviewed all clinical studies for this product and decided to close this Study
- Enrolment
- 329 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 31 Mar 2009 (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.
The purpose of this study is to monitor the performance of a large metal-on-metal bearing from the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery or a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.
The Study was terminated with effect from 30th November 2011 following the completion of 2 year follow up assessments for those patients remaining in the study.
Please note that prior to this decision DePuy voluntarily recalled the ASR products on 24 August 2010. Additional information regarding this voluntary recall and the follow-up of patients affected by the recall can be found at the following links http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON155761 and http://www.depuy.com/countries_list.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: DePuy ASR™ Hip SystemResurfacing system |
| 2 | Active comparator | Device: DePuy ASR™ XL Head / ASR™ Acetabular Cup SystemLarge Metal-on-Metal Total Hip Replacement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects with primary osteoarthritis indicated for standard MoM hip resurfacing arthroplasty with cementless fixation in the acetabulum.
- Subjects whose bone morphology and bone quality mean that standard MoM hip resurfacing arthroplasty is not indicated, but for whom cementless fixation in the acetabulum and receipt of a large MoM bearing are still possible.
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Subjects with compromised renal function defined as those whose measured values lie outside the normal range for a particular investigational site.
- Subjects with proven metal sensitivity.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DePuy ASR™ Hip SystemResurfacing system | Device | 1 |
| DePuy ASR™ XL Head / ASR™ Acetabular Cup SystemLarge Metal-on-Metal Total Hip Replacement | Device | 2 |
Primary outcome
Kaplan-Meier survivorship calculated at the five-year time-point
Time frame: 5yrs
7 secondary outcomes
Annual Kaplan-Meier survivorship calculations
Time frame: Annually
Harris Hip Score
Time frame: 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery
Radiographic analysis
Time frame: 3mths, 1yr, 2yrs, 5yrs, 10yrs, and 15yrs post-surgery
Oxford Hip Score
Time frame: 3mths, 6mths and annually post-surgery
UCLA Activity Score
Time frame: 3mths, 6mths and annually post-surgery
Hip Outcome Score
Time frame: 3mths, 6mths and annually post-surgery
EuroQol EQ-5D
Time frame: 3mths, 6mths and annually post-surgery
Results and safety
The study was stopped early (reason given: DePuy discontinued this product in 4Q2009. At the time of this decision DePuy reviewed all clinical studies for this product and decided to close this Study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DePuy ASR™ Hip System and DePuy ASR™ XL Head / ASR™ Acetabular Cup System in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International at 8 sites in 8 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 19 inclusion and 0 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: stopped early, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Austria, Czechia, Finland, Germany, Norway and 3 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: DePuy discontinued this product in 4Q2009. At the time of this decision DePuy reviewed all clinical studies for this product and decided to close 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?
Kaplan-Meier survivorship calculated at the five-year time-point (time frame: 5yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2016.