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A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00757354
First Posted: September 23, 2008
Last Update Posted: June 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biomet U.K. Ltd.
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip articulating surfaces in cementless total hip arthroplasty.

Condition Intervention
Osteoarthritis Avascular Necrosis Traumatic Arthritis Rheumatoid Arthritis Procedure: Metal on Metal cementless hip

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • concentration of Cobalt, Chromium and Molybdenum ions in urine [ Time Frame: various follow-up visits ]

Secondary Outcome Measures:
  • harris Hip Score, oxford hip, WOMAC and SF-12 [ Time Frame: various follow-up visits ]

Enrollment: 77
Study Start Date: June 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metal on Metal cementless hip
Metal on Metal cementless hip arthroplasty
Procedure: Metal on Metal cementless hip
Metal on Metal hip arthroplasty
Other Name: metal on metal 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757354


Locations
United Kingdom
Avon Orthopaedic Centre
Bristol, United Kingdom
Sponsors and Collaborators
Zimmer Biomet
Biomet U.K. Ltd.
Investigators
Principal Investigator: Evert J Smith, FRCS Avon Orthopaedic Centre
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00757354     History of Changes
Other Study ID Numbers: BMETEU.CR.EU46
First Submitted: September 22, 2008
First Posted: September 23, 2008
Last Update Posted: June 19, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Necrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes