OsteoarthritisNCT00757354
A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty
A study testing Metal on Metal cementless hip in people with Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 1 site in United Kingdom.
Trial summary
A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip articulating surfaces in cementless total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Traumatic Arthritis
- What is being tested?
- Metal on Metal cementless hip
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Mar 2014
- 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
- Subjects selected for this Evaluation will be grouped by initial diagnosis into one of the following diagnostic groups:
- Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis.
- Rheumatoid arthritis.
- Selection of subjects for this Evaluation should include the following considerations:
- Patients under 70 years of age.
- Willing to return for follow-up evaluations.
- No bias to sex.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip articulating surfaces in cementless total hip arthroplasty.
Read the detailed description
This evaluation is being conducted to investigate the extent of metal ion release and its incorporation into the surrounding tissue resulting from metal on metal articulating surfaces in cementless total hip arthroplasty.
The amount of metallic ions released post operatively will be assessed by the concentration of Cobalt, Chromium and Molybdenum present in urine and analysed by I.C.P.M.S. (Inductive Coupled Plasma Mass Spectroscopy). The amounts of metallic ions released will be related to the hip function and range of motion measured pre-operatively and post-operatively. Secondary performance of the metal-on-metal articulation will be determined by radiographic evaluation and incidence of complications / revision rates.
- Being tested
- Metal on Metal cementless hip
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metal on Metal cementless hipProcedure or surgery
Also called metal on metal hip arthroplasty
Metal on Metal hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Metal on Metal cementless hip | Experimental | Metal on Metal cementless hip arthroplasty Receives: Procedure: Metal on Metal cementless hip |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of Cobalt, Chromium and Molybdenum ions in urine
Measured: various follow-up visits
Secondary outcomes (1)
harris Hip Score, oxford hip, WOMAC and SF-12
Measured: various follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionMar 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomet U.K. Ltd.
- Responsible party
- Sponsor
- Investigators
- Evert J Smith, FRCS, Principal investigator, Avon Orthopaedic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757354
- Sponsor's protocol ID
- BMETEU.CR.EU46
- Status last verified
- Jun 2017
- First submitted
- 22 Sep 2008
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00757354
- Acronym / sponsor ID
- BMETEU.CR.EU46
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Biomet U.K. Ltd.
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 Sep 2008 (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.
A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip articulating surfaces in cementless total hip arthroplasty.
Detailed description
This evaluation is being conducted to investigate the extent of metal ion release and its incorporation into the surrounding tissue resulting from metal on metal articulating surfaces in cementless total hip arthroplasty.
The amount of metallic ions released post operatively will be assessed by the concentration of Cobalt, Chromium and Molybdenum present in urine and analysed by I.C.P.M.S. (Inductive Coupled Plasma Mass Spectroscopy). The amounts of metallic ions released will be related to the hip function and range of motion measured pre-operatively and post-operatively. Secondary performance of the metal-on-metal articulation will be determined by radiographic evaluation and incidence of complications / revision rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metal on Metal cementless hip | Experimental | Procedure: Metal on Metal cementless hipMetal on Metal cementless hip arthroplasty |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects selected for this Evaluation will be grouped by initial diagnosis into one of the following diagnostic groups:
- Selection of subjects for this Evaluation should include the following considerations:
Key exclusion criteria (0 listed)
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 Metal cementless hipAlso: metal on metal hip arthroplastyMetal on Metal hip arthroplasty | Procedure or surgery | Metal on Metal cementless hip |
Primary outcome
concentration of Cobalt, Chromium and Molybdenum ions in urine
Time frame: various follow-up visits
1 secondary outcome
harris Hip Score, oxford hip, WOMAC and SF-12
Time frame: various follow-up visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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.
Evert J Smith, FRCS principal investigator
Avon Orthopaedic Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metal on Metal cementless hip in people with Osteoarthritis and Avascular Necrosis, run by Zimmer Biomet at 1 site in United Kingdom.
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 0 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 19 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 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
concentration of Cobalt, Chromium and Molybdenum ions in urine (time frame: various follow-up visits). 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 19 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.