A Prospective Randomized Controlled Trial of Dual-Mobility Components in Primary THA

Running, not enrolling · Phase 4

Conditions studied: Serum Metal Levels, Specifically Cobalt, Chromium, and Titanium

In brief

The aim of this study is to determine if the use of a modular dual mobility bearing is associated with clinically important increases in serum metal levels.

Key facts

Study ID

NCT03371212

Run by

Rush University Medical Center

People needed

52

Starts

2017-12-15

Expected to finish

2036-12-01

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 and 80 years
• Willingness to undergo serial postoperative venipuncture for serum meal analysis
• BMI < 40
• Patients that are eligible for the requisite implants as deemed by their surgeon

You may not qualify if…

• Clinically significant systemic chronic disease
• Diminished renal function
• Presence of any metal-containing implant outside of the oral cavity
• History of prior hip surgery involving an internal fixation device
• History of hip infection
• Preoperative diagnosis other than osteoarthritis
• Anticipated need for another joint replacement surgery within one year
• Patients taking chromium supplements

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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