Investigation of Systemic Metal Ion Concentration Following a Ceramic-on-metal Total Hip Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Northwell Health
- Locations
- 1
- Primary Endpoint
- metal ion concentration in urine
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
metal ion concentration in urine
Time Frame: 1 year post-op
Secondary Outcomes
- metal ion concentration in blood(1 year post-op)
Investigators
Daniel Grande
director:orthopaedic research
Northwell Health