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

Sponsored by:	Biomet, Inc.
Information provided by:	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

MedlinePlus related topics: Osteoarthritis Osteonecrosis Rheumatoid Arthritis

U.S. FDA Resources

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

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 ]

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
1: Experimental Metal on Metal cementless hip arthroplasty	Procedure: metal on metal hip arthroplasty 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

Contacts

Contact: Evert J Smith, FRCS

+44(0)1179595207

Locations

United Kingdom
Avon Orthopaedic Centre	Recruiting
Bristol, United Kingdom
Contact: Evert J Smith, FRCS +44(0)1179595207

Sponsors and Collaborators

Biomet, Inc.

Investigators

Principal Investigator:

Evert J Smith, FRCS

Avon Orthopaedic Centre

More Information

No publications provided

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 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Necrosis
Autoimmune Diseases
Musculoskeletal Diseases
Osteonecrosis
Osteoarthritis
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Bone Diseases

Additional relevant MeSH terms:

Autoimmune Diseases
Osteonecrosis
Immune System Diseases
Osteoarthritis
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Bone Diseases
Necrosis
Pathologic Processes
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 07, 2009