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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757354
• Other study ID #: BMETEU.CR.EU46
• Status: Completed
• Phase: N/A
• First received: September 22, 2008
• Last updated: June 16, 2017
• Start date: June 2012
• Est. completion date: March 2014

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip articulating surfaces in cementless total hip arthroplasty.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis

Intervention

Procedure:
• Metal on Metal cementless hip
Metal on Metal hip arthroplasty

Locations

Country	Name	City	State
United Kingdom	Avon Orthopaedic Centre	Bristol

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer Biomet	Biomet U.K. Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of Cobalt, Chromium and Molybdenum ions in urine		various follow-up visits
Secondary	harris Hip Score, oxford hip, WOMAC and SF-12		various follow-up visits