Rheumatoid ArthritisPhase 4NCT00208364
A Two Centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Metal-on-Metal Bearing in Primary Total Hip Replacement
A Phase 4 study testing Pinnacle Acetabular Cup System in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International at 2 sites in 2 countries.
Trial summary
The purpose of this study is to monitor the performance and determine the metal ion release of the Pinnacle™ Cup with a metal-on-metal bearing combination in the treatment of patients with hip joint disease requiring a total hip replacement. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis
- What is being tested?
- Pinnacle Acetabular Cup System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2004to Sep 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged between 18 and 70 years inclusive.
- 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.
- Subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.
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 undergoing revision hip replacement.
- Women who are pregnant.
- 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 12 months.
- Subjects who are currently involved in any injury litigation claims.
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- Additional Exclusion Criteria for Subjects Having Blood Analysis:
- Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy.
- Subjects with an occupational exposure to cobalt or chromium.
- Subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months.
- Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
- Subjects who are undergoing a simultaneous bilateral total hip replacement.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup Prosthesis With a Metal on Metal Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement
The purpose of this study is to monitor the performance and determine the metal ion release of the Pinnacle™ Cup with a metal-on-metal bearing combination in the treatment of patients with hip joint disease requiring 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. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures
- Being tested
- Pinnacle Acetabular Cup System
- Keywords
- Hip, Cementless, Metal-on-Metal
- 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.
Pinnacle Acetabular Cup SystemDevice
A cementless acetabular cup with metal liner for use in total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| Pinnacle Acetabular Cup System | Other | A cementless acetabular cup with metal liner for use in total hip replacement Receives: Device: Pinnacle 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 5 year time point.
Measured: 5 years
Secondary outcomes (5)
Annual Kaplan-Meier survivorship calculationsMetal ion analysis in whole blood
Measured: Annually
Harris Hip score
Measured: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Oxford Hip score
Measured: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Radiological analysis
Measured: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Metal ion analysis in whole blood
Measured: pre-discharge, 6mths, 1yr, 2 yrs and 5yrs post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionOct 2014
- Study completionSep 2016
Why it stopped: Study terminated early due to business reasons
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
- 163 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
- NCT00208364
- Sponsor's protocol ID
- CT01/11
- Status last verified
- Sep 2016
- First submitted
- 13 Sep 2005
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup Prosthesis With a Metal on Metal Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement
- ClinicalTrials.gov ID
- NCT00208364
- Acronym / sponsor ID
- CT01/11
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures
- Keywords
- Hip, Cementless, Metal-on-Metal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early due to business reasons
- Enrolment
- 163 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Oct 2014 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Sep 2005 (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 Pinnacle™ Cup with a metal-on-metal bearing combination in the treatment of patients with hip joint disease requiring 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. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pinnacle Acetabular Cup System | Other | Device: Pinnacle Acetabular Cup SystemA cementless acetabular cup with metal liner for use in total hip replacement |
Who may qualify
- Ages
- 18 to 70 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 70 years inclusive.
- 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.
- Subjects undergoing primary total hip replacement who are suitable for cementless acetabular components.
Key exclusion criteria (12 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 undergoing revision hip replacement.
- Women who are pregnant.
- 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 12 months.
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 |
|---|---|---|
| Pinnacle Acetabular Cup SystemA cementless acetabular cup with metal liner for use in total hip replacement | Device | Pinnacle Acetabular Cup System |
Primary outcome
Kaplan-Meier survivorship calculated at the 5 year time point.
Time frame: 5 years
5 secondary outcomes
Annual Kaplan-Meier survivorship calculationsMetal ion analysis in whole blood
Time frame: Annually
Harris Hip score
Time frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Oxford Hip score
Time frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Radiological analysis
Time frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery
Metal ion analysis in whole blood
Time frame: pre-discharge, 6mths, 1yr, 2 yrs and 5yrs post-surgery
Results and safety
The study was stopped early (reason given: Study terminated early due to business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pinnacle Acetabular Cup System in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International at 2 sites in 2 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 12 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 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, United Kingdom. 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: Study terminated early due to business reasons). 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 5 year time point. (time frame: 5 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 7 Oct 2016; AzTrials last refreshed its copy on 27 Oct 2026.