Status:

COMPLETED

Serum Metal Ion Concentrations Following Primary Hip Arthroplasty

Lead Sponsor:

University of Utah

Conditions:

Healthy

Eligibility:

All Genders

18+ years

Brief Summary

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-functio...

Detailed Description

The objective of this study is to compare serum chromium and cobalt levels of patients who have undergone metal on metal total hip arthroplasty. The effect of the presence of bilateral large-head MOM...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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)

Key Trial Info

Start Date :

August 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2013

Estimated Enrollment :

39 Patients enrolled

Trial Details

Trial ID

NCT00714610

Start Date

August 1 2007

End Date

June 1 2013

Last Update

February 4 2014

Active Locations (1)

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1

University of Utah Orthopaedic Center

Salt Lake City, Utah, United States, 84108