OsteoarthritisMagnumCRCTNCT01247038
A Multicentre Trial to Compare Two Articulating Bearing Surfaces as Used in Cementless Primary Hip Arthroplasty
A study testing Metal on ceramic articulation and Metal-on-Metal in people with Osteoarthritis, run by Zimmer Biomet at 2 sites in 2 countries.
Trial summary
The aim of this study is to demonstrate the non-inferiority of the ceramic-on-metal articulation using large diameter bearings (38mm to 60mm) compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate at 2 years postoperatively (delta = 10% minimum clinically… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Metal on ceramic articulation and Metal-on-Metal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2011to 10 Jul 2015
- Phase
- Interventional
- 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
- Primary total hip replacement
- Patient with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of osteoarthritis,avascular necrosis, legg perthes, rheumatoid arthritis, diastrophic variant, fracture of the pelvis, fused hip, slipped capital epiphysis, subcapital fractures, traumatic arthritis
- Patients preoperative Harris hip score < 80 points
- 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
- Patient preoperative Harris hip score > 80 points
- Pre-existing metal implants
- Patients with significant co-morbidity - ASSA IV - V
- Dementia and inability to understand and follow instructions
- Neurological conditions affecting movement
- Women younger than 45 years old
Show all 9Show fewer
- Presence of symptomatic arthritis in other lower limb joints
- Patients requiring smaller than 38mm and larger than 60mm diameter femoral heads
- Patients taking NSAIDs and / all drugs that will affect bone metabolism
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Bosnia and Herzegovina1 site
Orthopaedic Hospital & Rehabilitation Clinic of "Dr Miroslav Zotovic"
Banja Luka
About this study
Official title: A Multicentre Prospective Randomised Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic on Metal and Metal on Metal Large Diameter Femoral Heads, 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 large diameter bearings (38mm to 60mm) compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate at 2 years postoperatively (delta = 10% minimum clinically significant difference in rates).
Read the detailed description
This multicentre randomised controlled trial will compare the clinical outcome of the ceramic-on-metal articulation against a metal-on-metal articulation using the same Recap Acetabular cup.
The metal ion release will be evaluated at predetermined postoperative intervals during the first 36 months. A trial will be conducted as a clinical trial in accordance with the Medical Devices Directive 93/42/EEC (2002).
A total of 150 patients have to be recruited from the South African centre (2 groups)
The initial study assessment period will be 48 months; 24 months recruitment and 24 months follow-up. The follow-up reviews will be at 6 weeks, 6 months, 1 year, 2 years and 3 years. A 5 year and 10 year clinical review will also be carried out with all patients.
An assessment of incidences of adverse events and metal ion release concentrations will be made when all patients are at 6 months postoperatively.
- Conditions
- Osteoarthritis
- Being tested
- Metal on ceramic articulation, 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.
Metal on ceramic articulationDevice
Also called MagnumC
Metal on ceramic articulation against metal-on-metal articulation using the same Recap Acetabular cup
Metal-on-MetalDevice
Also called Magnum
Metal on Metal articulation
| Study group | Role | What they receive |
|---|---|---|
| Metal on ceramic articulation | Experimental | The arm consists of patients with Ceramic femoral heads articulating with metal acetabular cups Receives: Device: Metal on ceramic articulation |
| Metal-on-metal | Active comparator | The arm consists of patients with Metal femoral heads articulating with metal acetabular cups Receives: Device: Metal-on-Metal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metal ion concentration in blood and urine
Metal ion concentration will be determined from patients blood and urine at prescribed intervals
Measured: 2 years post operatively
Secondary outcomes (1)
Composite Clinical Score (CCS) rate at 2 years post operative
Measured: 2 years post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startJan 2011
- Primary completion10 Jul 2015
- Study completion10 Jul 2015
Why it stopped: Biomet's focus has changed and we no longer expect further developments
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247038
- Sponsor's protocol ID
- BMETEU.CR.EU33
- Other IDs
- Biomet UK Healthcare Ltd
- Acronym
- MagnumCRCT
- Status last verified
- Jun 2017
- First submitted
- 22 Nov 2010
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Prospective Randomised Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic on Metal and Metal on Metal Large Diameter Femoral Heads, as Used in Cementless Primary Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01247038
- Acronym / sponsor ID
- MagnumCRCT / BMETEU.CR.EU33
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Biomet's focus has changed and we no longer expect further developments
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- 10 Jul 2015 (actual)
- Study completion
- 10 Jul 2015 (actual)
- First posted
- 24 Nov 2010 (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 aim of this study is to demonstrate the non-inferiority of the ceramic-on-metal articulation using large diameter bearings (38mm to 60mm) compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate at 2 years postoperatively (delta = 10% minimum clinically significant difference in rates).
Detailed description
This multicentre randomised controlled trial will compare the clinical outcome of the ceramic-on-metal articulation against a metal-on-metal articulation using the same Recap Acetabular cup.
The metal ion release will be evaluated at predetermined postoperative intervals during the first 36 months. A trial will be conducted as a clinical trial in accordance with the Medical Devices Directive 93/42/EEC (2002).
A total of 150 patients have to be recruited from the South African centre (2 groups)
The initial study assessment period will be 48 months; 24 months recruitment and 24 months follow-up. The follow-up reviews will be at 6 weeks, 6 months, 1 year, 2 years and 3 years. A 5 year and 10 year clinical review will also be carried out with all patients.
An assessment of incidences of adverse events and metal ion release concentrations will be made when all patients are at 6 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal on ceramic articulation | Experimental | Device: Metal on ceramic articulationThe arm consists of patients with Ceramic femoral heads articulating with metal acetabular cups |
| Metal-on-metal | Active comparator | Device: Metal-on-MetalThe arm consists of patients with Metal femoral heads articulating with metal acetabular cups |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary total hip replacement
- Patient with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of osteoarthritis,avascular necrosis, legg perthes, rheumatoid arthritis, diastrophic variant, fracture of the pelvis, fused hip, slipped capital epiphysis, subcapital fractures, traumatic arthritis
- Patients preoperative Harris hip score < 80 points
- Patients with limited co-morbidity - ASA I - III
- Patients with normal urea and electrolyte levels and creatinine levels
Key exclusion criteria (9 listed)
- Patient preoperative Harris hip score > 80 points
- Pre-existing metal implants
- Patients with significant co-morbidity - ASSA 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 |
|---|---|---|
| Metal on ceramic articulationAlso: MagnumCMetal on ceramic articulation against metal-on-metal articulation using the same Recap Acetabular cup | Device | Metal on ceramic articulation |
| Metal-on-MetalAlso: MagnumMetal on Metal articulation | Device | Metal-on-metal |
Primary outcome
Metal ion concentration in blood and urine
Time frame: 2 years post operatively
Metal ion concentration will be determined from patients blood and urine at prescribed intervals
1 secondary outcome
Composite Clinical Score (CCS) rate at 2 years post operative
Time frame: 2 years post operatively
Results and safety
The study was stopped early (reason given: Biomet's focus has changed and we no longer expect further developments). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Individual participant dataSharing planned: No
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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 study testing Metal on ceramic articulation and Metal-on-Metal in people with Osteoarthritis, run by Zimmer Biomet 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 7 inclusion and 9 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 21 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 2 sites in Bosnia and Herzegovina, 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.
Are results available for this study?
The study was stopped early (reason given: Biomet's focus has changed and we no longer expect further developments). 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?
Metal ion concentration in blood and urine (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?
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 21 Jun 2017.