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

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.

Study Overview

• Status: Withdrawn
• Conditions: Orthopaedic Surgery; Total Hip Arthroplasty; Hip Replacement; Hip Implant
• Intervention / Treatment: Biological: Blood draw; Radiation: X-Ray of Hip

Detailed 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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • Feinstein Institute for Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects enrolled will have already undergone a total hip arthroplasty with either a metal-on-metal articulation, or a ceramic-on-metal articulation.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Metal-on-Metal Articulations; Subjects will be people who have had metal-on-metal total hip arthroplasties	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
Ceramic-on-Metal Articulations; Subjects will be people who have had ceramic-on-metal total hip arthroplasties	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
metal ion concentration in urine	1 year post-op

Secondary Outcome Measures

Outcome Measure	Time Frame
metal ion concentration in blood	1 year post-op

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Daniel Grande, Ph.D., Feinstein Institute for Medical Research

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 17, 2009
• First Submitted That Met QC Criteria: April 17, 2009
• First Posted (Estimate): April 20, 2009

Study Record Updates

• Last Update Posted (Estimate): September 17, 2015
• Last Update Submitted That Met QC Criteria: September 16, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Metal Ion Concentration; Osteolysis
• Other Study ID Numbers: GCRC 0163; IRB# 07-08-105