A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty
NCT ID: NCT00757354
Last Updated: 2017-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2012-06-30
2014-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Metal on Metal cementless hip
Metal on Metal cementless hip arthroplasty
Metal on Metal cementless hip
Metal on Metal hip arthroplasty
Interventions
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Metal on Metal cementless hip
Metal on Metal hip arthroplasty
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Biomet U.K. Ltd.
INDUSTRY
Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Evert J Smith, FRCS
Role: PRINCIPAL_INVESTIGATOR
Avon Orthopaedic Centre
Locations
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Avon Orthopaedic Centre
Bristol, , United Kingdom
Countries
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Other Identifiers
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BMETEU.CR.EU46
Identifier Type: -
Identifier Source: org_study_id
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