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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Biomet U.K. Ltd.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00757354
First received: September 22, 2008
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  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 hip arthroplasty

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

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

Secondary Outcome Measures:
  • harris Hip Score, oxford hip, WOMAC and SF-12 [ Time Frame: various follow-up visits ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: June 2012
Estimated Study Completion Date: September 2015
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Metal on Metal cementless hip
Metal on Metal cementless hip arthroplasty
 Procedure: metal on metal hip arthroplasty
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757354

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

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00757354     History of Changes
Other Study ID Numbers: EU 46
Study First Received: September 22, 2008
Last Updated: July 12, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013