Rheumatoid ArthritisPhase 4NCT00872794
A Single Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
A Phase 4 study testing DePuy ASR™ Hip System in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International at 1 site in South Africa.
Trial summary
The purpose of this study is to monitor the performance and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Africa
- Study dates
- Nov 2003to May 2010
- 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
- Male or female subjects, aged between 18 and 65 years inclusive.
- Subjects with current indications for standard MoM hip resurfacing arthroplasty suitable for cementless fixation in the acetabulum. These include pain, deformity, and loss of function, which are not responsive to medical treatment.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects, who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Who cannot join
- 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 proven significant osteoporosis and poor bone quality.
- Subjects with compromised renal function.
- Subjects with proven metal sensitivity.
- Subjects with infectious, highly communicable diseases, which may limit follow-up i.e. Active tuberculosis, hepatitis, immuno-compromised conditions, etc.
- Women who are pregnant.
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- 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.
- Additional Exclusion Criteria for Subjects Undergoing Blood Analysis
- Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium, titanium alloy.
- Subjects who, in the opinion of the investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Single-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of the DePuy ASR™ Hip in Subjects With Suitable Indications for a Primary Resurfacing Hip Arthroplasty
The purpose of this study is to monitor the performance and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined and undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored.
DePuy decided to close this Study in 4Q 2009. The Study was terminated with effect from November 2010 to allow for the completion of the 5 year follow up assessments.
Please note that subsequent 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/CON079157 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
- Keywords
- Hip, Conservative, Metal on Metal, Resurfacing
- 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
A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| DePuy ASR Hip System | Other | A metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty. Receives: Device: DePuy ASR™ Hip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kaplan-Meier survivorship at two years
Measured: 2 years
Secondary outcomes (8)
UCLA Activity Score
Measured: Annually
WOMAC Score
Measured: Annually
Activity Assessment.
Measured: Annually
Kaplan-Meier survivorship calculation
Measured: Annually
Harris Hip Score
Measured: pre-discharge, 3mths, 1yr, 2yrs, 5yrs,10yrs and 15yrs post-surgery
Radiographic analysis
Measured: pre-discharge, 3mths, 1yr, 2yrs, 5yrs,10yrs and 15yrs post-surgery
Metal ion analysis in whole blood
Measured: 3mths, 6mths, 1yr, 2yrs and 5 yrs post-surgery
Bone mineral density (DEXA)
Measured: 3mths, 1yr, 2yrs and 5 yrs 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 startNov 2003
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: DePuy discontinued this product in 4Q 2009.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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT00872794
- Sponsor's protocol ID
- CT03/29
- Status last verified
- Jun 2017
- First submitted
- 19 Mar 2009
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of the DePuy ASR™ Hip in Subjects With Suitable Indications for a Primary Resurfacing Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00872794
- Acronym / sponsor ID
- CT03/29
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Nonunion of Femoral Fractures
- Keywords
- Hip, Conservative, Metal on Metal, Resurfacing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DePuy discontinued this product in 4Q 2009.At the time of this decision DePuy reviewed all clinical studies for this product and decided to close this Study.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (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 and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined and undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored.
DePuy decided to close this Study in 4Q 2009. The Study was terminated with effect from November 2010 to allow for the completion of the 5 year follow up assessments.
Please note that subsequent 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/CON079157 and http://www.depuy.com/countries_list.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DePuy ASR Hip System | Other | Device: DePuy ASR™ Hip SystemA metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects, aged between 18 and 65 years inclusive.
- Subjects with current indications for standard MoM hip resurfacing arthroplasty suitable for cementless fixation in the acetabulum. These include pain, deformity, and loss of function, which are not responsive to medical treatment.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects, who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Key exclusion criteria (13 listed)
- 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 proven significant osteoporosis and poor bone quality.
- Subjects with compromised renal function.
- Subjects with proven metal sensitivity.
- Subjects with infectious, highly communicable diseases, which may limit follow-up i.e. Active tuberculosis, hepatitis, immuno-compromised conditions, etc.
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 SystemA metal-on-metal bearing surface replacement system for use in resurfacing hip arthroplasty. | Device | DePuy ASR Hip System |
Primary outcome
Kaplan-Meier survivorship at two years
Time frame: 2 years
8 secondary outcomes
UCLA Activity Score
Time frame: Annually
WOMAC Score
Time frame: Annually
Activity Assessment.
Time frame: Annually
Kaplan-Meier survivorship calculation
Time frame: Annually
Harris Hip Score
Time frame: pre-discharge, 3mths, 1yr, 2yrs, 5yrs,10yrs and 15yrs post-surgery
Radiographic analysis
Time frame: pre-discharge, 3mths, 1yr, 2yrs, 5yrs,10yrs and 15yrs post-surgery
Metal ion analysis in whole blood
Time frame: 3mths, 6mths, 1yr, 2yrs and 5 yrs post-surgery
Bone mineral density (DEXA)
Time frame: 3mths, 1yr, 2yrs and 5 yrs post-surgery
Results and safety
The study was stopped early (reason given: DePuy discontinued this product in 4Q 2009.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 26 Jun 2017.
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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.
1 site in 1 country: 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 in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International at 1 site in South Africa.
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 13 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 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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 4Q 2009.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 at two years (time frame: 2 years). 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 26 Jun 2017.