OsteoarthritisNCT00754520
A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty
A study testing Ceramic On Metal and Metal on Metal in people with Osteoarthritis, run by Zimmer Biomet at 3 sites in 2 countries.
Trial summary
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Ceramic On Metal and Metal on Metal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2009to Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with osteoarthritis and suitable for primary Total Hip Replacement
- Patients preoperative Harris Hip Score <= 70 points
- Patients aged over 18 and under 75
- Patients with limited co-morbidity - ASA I-III
- Patients with normal urea and electrolyte levels and creatinine levels
- Patients must be able to understand instructions and be willing to return for follow-up
- Patients willing to provide blood and urine samples for metal ion analysis at follow up
Who cannot join
- Patients preoperative Harris Hip Score > 70 points
- Previous prosthetic hip surgery
- Patients with significant co-morbidity - ASA IV - V
- Dementia and inability to understand and follow instructions
- Neurological conditions affecting movement
- Existing metal implant or fixation device
- Pregnancy
- Presence of symptomatic arthritis in other lower limb joints
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Finland2 sites
Central Finland Central Hospital
Jyväskylä
Kymenlaakso Central Hospital
Kotka
About this study
Official title: A Multi-center Prospective Randomized Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic-on-metal and Metal-on-metal as Used in Cementless Primary Hip Arthroplasty
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup.
Read the detailed description
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate, as defined in the protocol, at 2 year postoperative.
- Conditions
- Osteoarthritis
- Being tested
- Ceramic On Metal, Metal on Metal
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceramic On MetalDevice
Ceramic on Metal articulation using M2a-38™ mm cup
Metal on MetalDevice
Metal on Metal articulation using M2a-38™ mm cup
| Study group | Role | What they receive |
|---|---|---|
| Ceramic On Metal | Experimental | This arm utilizes the ceramic on metal articulation using the M2a-38™ mm cup. Receives: Device: Ceramic On Metal |
| Metal on Metal | Active comparator | This arm utilizes the metal on metal articulation using M2a-38™ mm cup. Receives: Device: Metal on Metal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Clinical Success (CCS) Rate as Defined in the Protocol
CCS is defined as:
- Total Harris Hip Score > 80 points, and b. No acetabular or femoral revision or removal, and c. No pending acetabular or femoral revision or removal as defined in radiographic evaluation by: i. An acetabular radiographic assessment with all of the following:
- Migration < 4 mm, and
- Change in angle of inclination < 4o, and
- Absence of osteolysis, and ii. A femoral radiographic assessment with all of the following:
- Subsidence < 5 mm, and 2. Absence of osteolysis.
The HHS including a series of questions answered by the patient and physical examinations recorded by a qualified health care professional covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70
Measured: 2 years post-operatively
Secondary outcomes (4)
Oxford Hip Score
The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27.
Measured: pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively
Womac Score
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score) is a standardised patient reported outcome measure consisting of 24 items divided into 3 sub-sections: Pain (5 items), stiffness (2 items) and physical function or "Activities of Daily Living; ADL" (17 items). A higher score indicates a worse clinical outcome. The maximum score for each subsection is Pain: 20 - 0; Stiffness: 8 - 0; ADL: 68 - 0.
Measured: pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively
Metal Ion Concentrations in Blood
Chromium and Cobalt concentrations in blood are measured in measurement unit nmol/L. The change from baseline analysis is presented.
Measured: 6 months post-operatively, 1, 2, 3 and 5 years post-operatively
Survivorship
Survival of the implant based on the removal or intended removal of the device. The percentage of patients that still have the implant 10 years post-operative is presented here.
Measured: 10 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startMay 2009
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- G. Stranks, FRCS, Principal investigator, North Hampshire HospitalM Pesola, Principal investigator, Central Finland Hospital DistrictH Kauppinen, Principal investigator, Kymenlaakso Central Hospital Kotka Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754520
- Sponsor's protocol ID
- BMETEU.CR.EU11
- Status last verified
- Jul 2024
- First submitted
- 16 Sep 2008
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Higgins JE, Conn KS, Britton JM, Pesola M, Manninen M, Stranks GJ. Early Results of Our International, Multicenter, Multisurgeon, Double-Blinded, Prospective, Randomized, Controlled Trial Comparing Metal-on-Metal With Ceramic-on-Metal in Total Hip Arthroplasty. J Arthroplasty. 2020 Jan;35(1):193-197.e2. doi: 10.1016/j.arth.2019.08.002. Epub 2019 Aug 22.
PubMed 31540737
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Randomized Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic-on-metal and Metal-on-metal as Used in Cementless Primary Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00754520
- Acronym / sponsor ID
- BMETEU.CR.EU11
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Posted 2 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup.
Detailed description
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate, as defined in the protocol, at 2 year postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceramic On Metal | Experimental | Device: Ceramic On MetalThis arm utilizes the ceramic on metal articulation using the M2a-38™ mm cup. |
| Metal on Metal | Active comparator | Device: Metal on MetalThis arm utilizes the metal on metal articulation using M2a-38™ mm cup. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients presenting with osteoarthritis and suitable for primary Total Hip Replacement
- Patients preoperative Harris Hip Score <= 70 points
- Patients aged over 18 and under 75
- Patients with limited co-morbidity - ASA I-III
- Patients with normal urea and electrolyte levels and creatinine levels
Key exclusion criteria (8 listed)
- Patients preoperative Harris Hip Score > 70 points
- Previous prosthetic hip surgery
- Patients with significant co-morbidity - ASA IV - V
- Dementia and inability to understand and follow instructions
- Neurological conditions affecting movement
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 |
|---|---|---|
| Ceramic On MetalCeramic on Metal articulation using M2a-38™ mm cup | Device | Ceramic On Metal |
| Metal on MetalMetal on Metal articulation using M2a-38™ mm cup | Device | Metal on Metal |
Primary outcome
Composite Clinical Success (CCS) Rate as Defined in the Protocol
Time frame: 2 years post-operatively
CCS is defined as: a. Total Harris Hip Score > 80 points, and b. No acetabular or femoral revision or removal, and c. No pending acetabular or femoral revision or removal as defined in radiographic evaluation by: i. An acetabular radiographic assessment with all of the following: 1. Migration < 4 mm, and 2. Change in angle of inclination < 4o, and 3. Absence of osteolysis, and ii. A femoral radiographic assessment with all of the following: 1. Subsidence < 5 mm, and 2. Absence of osteolysis. The HHS including a series of questions answered by the patient and physical examinations recorded by a qualified health care professional covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70
4 secondary outcomes
Oxford Hip Score
Time frame: pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively
Womac Score
Time frame: pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively
Metal Ion Concentrations in Blood
Time frame: 6 months post-operatively, 1, 2, 3 and 5 years post-operatively
Survivorship
Time frame: 10 years post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31540737Higgins JE, Conn KS, Britton JM, Pesola M, Manninen M, Stranks GJ. Early Results of Our International, Multicenter, Multisurgeon, Double-Blinded, Prospective, Randomized, Controlled Trial Comparing Metal-on-Metal With Ceramic-on-Metal in Total Hip Arthroplasty. J Arthroplasty. 2020 Jan;35(1):193-197.e2. doi: 10.1016/j.arth.2019.08.002. Epub 2019 Aug 22.
- Individual participant dataSharing planned: Undecided
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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.
G. Stranks, FRCS principal investigator
North Hampshire Hospital
M Pesola principal investigator
Central Finland Hospital District
H Kauppinen principal investigator
Kymenlaakso Central Hospital Kotka Finland
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ceramic On Metal and Metal on Metal in people with Osteoarthritis, run by Zimmer Biomet at 3 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 7 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: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland, 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite Clinical Success (CCS) Rate as Defined in the Protocol (time frame: 2 years post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00754520, which also lists 1 linked publication.
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 2 Oct 2024.