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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00883805
• Other study ID #: GCRC 0163
• Secondary ID: IRB# 07-08-105
• Status: Withdrawn
• Phase: N/A
• First received: April 17, 2009
• Last updated: September 16, 2015
• Start date: April 2009

Study information

• Verified date: September 2015
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject is 40 - 80, who has undergone a top hip arthroplasty with either metal on metal or ceramic on metal articulation for a diagnosis of non-inflammatory degenerative joint disease. We will also include subjects who have had bilateral hip arthroplasties or a second arthroplasty performed since the initial surgery.

• Patient must be able to provide consent to participate

Exclusion Criteria:

• Diagnosis other than non-inflammatory degenerative joint disease, chronic renal insufficiency, or any systemic inflammatory condition

• Evidence of active infections

• Patients whose occupations include welding or metal working

• A second arthroplasty performed since the initial will not be exclude, but their data will be analyzed as a subpopulation

• unwillingness to comply with rehabilitation program or inability to return for follow-up visits

• Any systemic steroid therapy within 3 months of surgery

• Subjects who are pregnant

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hip Implant
• Hip Replacement
• Orthopaedic Surgery
• Total Hip Arthroplasty

Intervention

Biological:
• Blood draw
Subjects will give blood for analysis of metal ion concentrations

Radiation:
• X-Ray of Hip
Subject will have x-ray of hip to assessment of osteolysis

Locations

Country	Name	City	State
United States	Feinstein Institute for Medical Research	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metal ion concentration in urine		1 year post-op	Yes
Secondary	metal ion concentration in blood		1 year post-op	Yes