Clinical trial NCT00883805: Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty
Official title: Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hip Replacement
Hip Implant
Total Hip Arthroplasty
Orthopaedic Surgery
Keywords: Metal Ion Concentration
Osteolysis
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2009-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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

Primary outcomes:
measure: metal ion concentration in urine
timeFrame: 1 year post-op
Secondary outcomes:
measure: metal ion concentration in blood
timeFrame: 1 year post-op
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
Study officials:
affiliation: Feinstein Institute for Medical Research
name: Daniel Grande, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: