Serum Metal Ion Concentrations Following Primary Hip Arthroplasty

Completed

Conditions studied: Healthy

In brief

The objective of this study is to compare serum chromium and cobalt levels of patients who have undergone metal on metal total hip arthroplasty. It is unknown if the presence of bilateral well-functioning large-head metal-on-metal (MOM) total hip arthroplasties (THAs) leads to higher serum metal ion concentrations than unilateral MOM THA. Elevated levels (chromium, 17 μg/L; cobalt, 19 μg/L) have been associated with poorly functioning MOM THA with metallosis. Fourteen patients having undergone bilateral and 25 patients having undergone unilateral large-head primary MOM THA were compared. Harris Hip Scores, University of California Los Angeles activity scores, radiographs, serum creatinine, and serum cobalt and chromium levels were obtained.

Key facts

Study ID

NCT00714610

Run by

University of Utah

People needed

39

Starts

2007-08-01

Expected to finish

2013-06-01

Last updated by the study team

2014-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• undergone unilateral large-head (≥38 mm) primary MOM THA
• undergone bilateral large-head primary MOM THA
• 18 years old or older
• at least one year out from their index procedure
• had well-positioned components

You may not qualify if…

• other metal implants
• renal insufficiency (estimated creatinine clearance b30 mL/min)
• component malpositioning (cup inclination angle N55°)
• evidence of osteolysis on radiographs
• a poorly functioning hip (Harris Hip Score [HHS] b70)

Where it is running

• University of Utah Orthopaedic Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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