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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Daniel Grande, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00883805
First received: April 17, 2009
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Hip Replacement
Hip Implant
Total Hip Arthroplasty
Orthopaedic Surgery
 Biological: Blood draw
Radiation: X-Ray of Hip

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: X-Rays
U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • metal ion concentration in urine [ Time Frame: 1 year post-op ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • metal ion concentration in blood [ Time Frame: 1 year post-op ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883805

Locations
United States, New York
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Daniel Grande, Ph.D. Feinstein Institute for Medical Research
  More Information

No publications provided

Responsible Party: Daniel Grande, director:orthopaedic research, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00883805     History of Changes
Other Study ID Numbers: GCRC 0163, IRB# 07-08-105
Study First Received: April 17, 2009
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Metal Ion Concentration
Osteolysis

ClinicalTrials.gov processed this record on May 19, 2013