NCT00757354

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Osteoarthritis
• Avascular Necrosis
• Traumatic Arthritis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
PROCEDURE	Metal on Metal cementless hip	Metal on Metal hip arthroplasty

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2008-09-23
• Last updated: 2017-06-19

Locations

1 site across 1 country: United Kingdom