OsteoarthritisPhase 4NCT00873444
A Randomised Study to Compare Metal Ion Release and Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-Metal or a Metal-on-Metal Bearing
A Phase 4 study testing Pinnacle™ Acetabular System in people with Osteoarthritis and Post-traumatic Arthritis, run by DePuy International at 1 site in Germany.
Trial summary
The purpose of this study is to monitor the performance and compare the metal ion release of two bearing combinations, ceramic-on-metal and metal-on-metal in the treatment of patients with hip joint disease requiring a total hip replacement. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders
- 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
- 5 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2006to Nov 2006
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature male or female subjects, aged between 20 and 75 years inclusive at the time of surgery.
- 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 unilateral primary total hip replacement who are suitable for a cementless acetabular component and whose femoral and acetabular bone stock is suitable to receive implants, without the requirement for a bone graft.
- Subjects with radiographic evidence and primary diagnosis of non-inflammatory degenerative joint disease (NIDJD).
- Subjects with a pre-operative Harris Hip Score of less than or equal to 70 and a pain rating of at least moderate for the operative hip.
Who cannot join
- Subjects who, in the opinion of the Investigator, have an existing condition, such as active infections, highly communicable diseases, neurological or musculoskeletal disorders that might affect weight-bearing and metastatic or neoplastic disease, that would compromise their participation and follow-up in this study.
- Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties, unless known to be titanium alloy only.
- Patients who have received a total hip arthroplasty in the contralateral hip within the previous 12 months unless known to be titanium alloy only.
- Subjects who have undergone previous hip surgery on the operative hip (including previous hip/surface replacements, resection arthroplasty or surgical fusion of the hip).
- Subjects requiring a simultaneous bilateral hip operation.
- Subjects who, in the opinion of the investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
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- Subjects with an acute femoral neck fracture of the operative hip.
- Subjects who have undergone above knee amputation of the contralateral and/or ipsilateral leg.
- Subjects with compromised renal function.
- Subjects with a known allergy to metal (eg, jewellery).
- Subjects with an occupational exposure to cobalt, chromium, molybdenum, titanium or nickel.
- Subjects who have ingested medication or vitamins containing cobalt, chromium, molybdenum, titanium or nickel within the last 12 months, or intend to ingest such substances over the next 2 years.
- Subjects who have undergone systemic steroid therapy, excluding inhalers, in the three months prior to surgery.
- Women who are pregnant.
- Subjects who are prisoners, 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Controlled, Prospective, Multi-Centre, Post Market Surveillance Study Comparing a Ceramic-on-Metal Bearing and a Metal-on-Metal Bearing in Subjects Requiring Primary Total Hip Arthroplasty for Non-Inflammatory Degenerative Joint Disease
The purpose of this study is to monitor the performance and compare the metal ion release of two bearing combinations, ceramic-on-metal and metal-on-metal in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the bearing combinations and will be evaluated at regular intervals using, patient, clinical and x-ray assessments. Patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Congenital Hip Dysplasia, Slipped Capital Femoral Epiphysis
- Being tested
- Pinnacle™ Acetabular System
- Keywords
- Hip, Cementless, Ceramic-on-Metal, Metal-on-Metal
- Medical subject headings
- 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
A cementless acetabular cup with ceramic liner for use in total hip replacement
Pinnacle™ Acetabular SystemDevice
A cementless acetabular cup with metal liner for use in total hip replacement
| Study group | Role | What they receive |
|---|---|---|
| 1) Ceramic-on-Metal Bearing | Active comparator | A cementless acetabular cup with ceramic liner for use in total hip replacement Receives: Device: Pinnacle™ Acetabular System |
| 2) Metal-on-Metal Bearing | Active comparator | A cementless acetabular cup with metal liner for use in total hip replacement Receives: Device: Pinnacle™ Acetabular System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobalt metal ion levels in the blood at 2 years post surgery
Measured: 2 years post-surgery
Secondary outcomes (7)
Kaplan-Meier survivorship calculations
Measured: Annually
Oxford Hip Score
Measured: 6 weeks, 6 months, and Annually
UCLA Score
Measured: 6 weeks, 6 months, and Annually
Pain Visual Analogue Scale
Measured: 6 weeks, 6 months, and Annually
Harris Hip Score
Measured: 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Radiographic analysis
Measured: 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Blood metal ion levels
Measured: pre-discharge, 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startJul 2006
- Primary completionNov 2006
- Study completionNov 2006
Why it stopped: Study progress very slow therefore terminated as other projects underway to investigate the same research question which will deliver results earlier
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT00873444
- Sponsor's protocol ID
- CT00/37
- Status last verified
- Mar 2016
- First submitted
- 19 Mar 2009
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Controlled, Prospective, Multi-Centre, Post Market Surveillance Study Comparing a Ceramic-on-Metal Bearing and a Metal-on-Metal Bearing in Subjects Requiring Primary Total Hip Arthroplasty for Non-Inflammatory Degenerative Joint Disease
- ClinicalTrials.gov ID
- NCT00873444
- Acronym / sponsor ID
- CT00/37
- Conditions
- Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Congenital Hip Dysplasia, Slipped Capital Femoral Epiphysis
- Keywords
- Hip, Cementless, Ceramic-on-Metal, Metal-on-Metal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study progress very slow therefore terminated as other projects underway to investigate the same research question which will deliver results earlier
- Enrolment
- 5 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 1 Apr 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 compare the metal ion release of two bearing combinations, ceramic-on-metal and metal-on-metal in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the bearing combinations and will be evaluated at regular intervals using, patient, clinical and x-ray assessments. 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1) Ceramic-on-Metal Bearing | Active comparator | Device: Pinnacle™ Acetabular SystemA cementless acetabular cup with ceramic liner for use in total hip replacement |
| 2) Metal-on-Metal Bearing | Active comparator | Device: Pinnacle™ Acetabular SystemA cementless acetabular cup with metal liner for use in total hip replacement |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Skeletally mature male or female subjects, aged between 20 and 75 years inclusive at the time of surgery.
- 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 unilateral primary total hip replacement who are suitable for a cementless acetabular component and whose femoral and acetabular bone stock is suitable to receive implants, without the requirement for a bone graft.
- Subjects with radiographic evidence and primary diagnosis of non-inflammatory degenerative joint disease (NIDJD).
Key exclusion criteria (17 listed)
- Subjects who, in the opinion of the Investigator, have an existing condition, such as active infections, highly communicable diseases, neurological or musculoskeletal disorders that might affect weight-bearing and metastatic or neoplastic disease, that would compromise their participation and follow-up in this study.
- Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties, unless known to be titanium alloy only.
- Patients who have received a total hip arthroplasty in the contralateral hip within the previous 12 months unless known to be titanium alloy only.
- Subjects who have undergone previous hip surgery on the operative hip (including previous hip/surface replacements, resection arthroplasty or surgical fusion of the hip).
- Subjects requiring a simultaneous bilateral hip operation.
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 SystemA cementless acetabular cup with ceramic liner for use in total hip replacement | Device | 1) Ceramic-on-Metal Bearing |
| Pinnacle™ Acetabular SystemA cementless acetabular cup with metal liner for use in total hip replacement | Device | 2) Metal-on-Metal Bearing |
Primary outcome
Cobalt metal ion levels in the blood at 2 years post surgery
Time frame: 2 years post-surgery
7 secondary outcomes
Kaplan-Meier survivorship calculations
Time frame: Annually
Oxford Hip Score
Time frame: 6 weeks, 6 months, and Annually
UCLA Score
Time frame: 6 weeks, 6 months, and Annually
Pain Visual Analogue Scale
Time frame: 6 weeks, 6 months, and Annually
Harris Hip Score
Time frame: 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Radiographic analysis
Time frame: 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Blood metal ion levels
Time frame: pre-discharge, 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Results and safety
The study was stopped early (reason given: Study progress very slow therefore terminated as other projects underway to investigate the same research question which will deliver results earlier). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 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.
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 Pinnacle™ Acetabular System in people with Osteoarthritis and Post-traumatic Arthritis, run by DePuy International at 1 site in Germany.
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 6 inclusion and 17 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 11 May 2016. 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 Germany. 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 progress very slow therefore terminated as other projects underway to investigate the same research question which will deliver results earlier). 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?
Cobalt metal ion levels in the blood at 2 years post surgery (time frame: 2 years 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 11 May 2016; AzTrials last refreshed its copy on 30 Oct 2026.