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Sponsored by: |
Biomet, Inc. |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00757354 |
A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip articulating surfaces in cementless total hip arthroplasty.
Condition | Intervention |
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Osteoarthritis Avascular Necrosis Traumatic Arthritis Rheumatoid Arthritis |
Procedure: metal on metal hip arthroplasty |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty |
Estimated Enrollment: | 500 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | March 2020 |
Estimated Primary Completion Date: | March 2020 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Metal on Metal cementless hip arthroplasty
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Procedure: metal on metal hip arthroplasty
metal on metal hip arthroplasty
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Exclusion Criteria:
Contact: Evert J Smith, FRCS | +44(0)1179595207 |
United Kingdom | |
Avon Orthopaedic Centre | Recruiting |
Bristol, United Kingdom | |
Contact: Evert J Smith, FRCS +44(0)1179595207 |
Principal Investigator: | Evert J Smith, FRCS | Avon Orthopaedic Centre |
Responsible Party: | Biomet UK ( David Stephenson ) |
Study ID Numbers: | BMET UK 02 |
Study First Received: | September 22, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00757354 |
Health Authority: | United Kingdom: Research Ethics Committee |
Necrosis Autoimmune Diseases Musculoskeletal Diseases Osteonecrosis Osteoarthritis Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Bone Diseases |
Pathologic Processes Immune System Diseases |