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

Withdrawn before enrolling

Conditions studied: Hip Replacement, Hip Implant, Total Hip Arthroplasty, Orthopaedic Surgery

In brief

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.

Key facts

Study ID

NCT00883805

Run by

Northwell Health

People needed

0

Starts

2009-04-01

Last updated by the study team

2015-09-17

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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