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Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty

Total Hip Arthroplasty Clinical Trial

Official title:
Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty

Clinical Trial Summary

This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces.

Clinical Trial Description

This is a pilot study to compare systemic concentrations of cobalt and chromium in patients that have previously undergone total hip arthroplasties with ceramic on metal and metal on metal bearing surfaces. Secondary goals include an assessment of osteolysis on radiographs, potential long term analysis of implant survivability, and cancer rates in the two patient populations.

Increased metal ion production has been documented in metal-on-metal arthroplasty articulations. There are several concerns over metal ion production. First, even though there is a decreased histiocytic response to metallic debris, a dose dependent cytotoxic response with Interleukin 6, Prostaglandin E2, and Tumor Necrosis Factor alpha persists and may cause osteolysis in the long term. Second, increased levels of cobalt, chromium and nickel has been shown to correlate with increased cancer rates in several animal models, and the carcinogenic risk in humans has not been fully elucidated as yet. Third, hypersensitivity reactions to metal ion develop in up to 25% of these patients, and 60% of patients with poorly functioning hip.

Ceramic on metal avoids many of these problems due to the improved wear characteristics. If the level of metal ion production is significantly reduced and the implant survivability is proven in long term studies, this articulation may become the preferred method. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00883805
Study type Observational
Source Northwell Health
Contact
Status Withdrawn
Phase N/A
Start date April 2009
View Details
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