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

Sponsor:	Biomet, Inc.
Collaborator:	Biomet U.K. Ltd.
Information provided by (Responsible Party):	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00757354

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:

MedlinePlus related topics: Osteoarthritis Osteonecrosis Rheumatoid Arthritis

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:	86
Study Start Date:	March 2006
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (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:	December 5, 2011
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 February 09, 2012