Rheumatoid ArthritisPhase 4NCT00208429
A Multi-centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Polyethylene-on-metal Bearing in Primary Total Hip Replacement
A Phase 4 study testing Pinnacle Acetabular System in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International.
Trial summary
The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a polyethylene-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 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2004to 1 Jul 2019
- 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 a cementless acetabular component and a metal on polyethylene bearing.
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.
- Subjects undergoing simultaneous bilateral hip operation.
- Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.
- 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.
About this study
Official title: Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup System With a Metal on Enduron Polyethylene Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement
The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a polyethylene-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.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures
- Being tested
- Pinnacle Acetabular System
- Keywords
- Hip, Cementless
- 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 SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Pinnacle Acetabular System | Other | Not described Receives: Device: Pinnacle Acetabular 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: 5 yrs post surgery
Secondary outcomes (3)
Change in Baseline to post-operative assessment in clinical outcome using the Harris Hip Score
Measured: 6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
Change in Baseline to post-operative assessment in clinical outcome using the Oxford Hip Score
Measured: Annually up to 15 yrs post-surgery
Kaplan-Meier survivorship
Measured: Annually up to 15 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 posted21 Sep 2005 (estimated)
- Study start1 Jul 2004
- Primary completion1 Jul 2009 (estimated)
- Study completion1 Jul 2019 (estimated)
Why it stopped: Site Principal Investigator became seriously ill, so study abandoned before the start of recruitment
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
- 0 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
- NCT00208429
- Sponsor's protocol ID
- CT03/40
- Status last verified
- Jun 2017
- First submitted
- 13 Sep 2005
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. 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 System With a Metal on Enduron Polyethylene Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement
- ClinicalTrials.gov ID
- NCT00208429
- Acronym / sponsor ID
- CT03/40
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures
- Keywords
- Hip, Cementless
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Site Principal Investigator became seriously ill, so study abandoned before the start of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2004 (actual)
- Primary completion
- 1 Jul 2009 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- 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 of the Pinnacle™ Cup with a polyethylene-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.
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 System | Other | Device: Pinnacle Acetabular System |
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 a cementless acetabular component and a metal on polyethylene bearing.
Key exclusion criteria (8 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.
- Subjects undergoing simultaneous bilateral hip operation.
- Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.
- Women who are pregnant.
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 System | Device | Pinnacle Acetabular System |
Primary outcome
Kaplan-Meier survivorship calculated at the five-year time-point.
Time frame: 5 yrs post surgery
3 secondary outcomes
Change in Baseline to post-operative assessment in clinical outcome using the Harris Hip Score
Time frame: 6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
Change in Baseline to post-operative assessment in clinical outcome using the Oxford Hip Score
Time frame: Annually up to 15 yrs post-surgery
Kaplan-Meier survivorship
Time frame: Annually up to 15 yrs post-surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pinnacle Acetabular System in people with Rheumatoid Arthritis and Osteoarthritis, run by DePuy International.
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 8 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: withdrawn, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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: 5 yrs post surgery). 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 28 Jun 2017.