Serum Metal Ion Concentrations Following Primary Hip Arthroplasty

NCT00714610 | Completed DMC

• 1 other identifier: 21498
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Healthy

Keywords

Serum metal ion concentration

Outcome Measures

Primary Outcomes (1)

• Serum Metal Ion Concentrations

  1 year

Study Arms (1)

1

Unilateral or bilateral large head metal on metal primary total hip arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Two groups were identified: the first group having undergone unilateral large-head (≥38 mm) primary MOM THA and the second having undergone bilateral large-head primary MOM THA. Patients were at least 18 years old, were at least 1 year out from their index procedure, and had well-positioned components. Patients in both cohorts had cementless modular titanium alloy proximally porous-coated, tapered femoral stems (Biomet Taperloc or Bi-Metric; Biomet, Warsaw, Ind). All surgeries were done between the years of 2003 and 2009.

You may qualify if:

• undergone unilateral large-head (≥38 mm) primary MOM THA
• undergone bilateral large-head primary MOM THA
• 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)

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be drawn for analysis.

Study Officials

• Christopher Peters, MD

  University of Utah Orthopaedic Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 14, 2008
• Study Start: August 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

US (1)