Active — Not RecruitingPhase 4

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

United States52 participantsStarted 2017-12-15

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Serum chromium levels, measures chromium level in the serum in ug/L

Timeframe: up to 5 years

Serum cobalt levels, measures cobalt level in the serum in ug/L

Timeframe: up to 5 years

Serum titanium levels, measures titanium level in the serum in ug/L

Timeframe: up to 5 years

Trial details

NCT IDNCT03371212

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2035-12-01

View on ClinicalTrials.gov More Serum Metal Levels, Specifically Cobalt, Chromium, and Titanium trials