Status:
ACTIVE_NOT_RECRUITING
A Prospective Randomized Controlled Trial of Dual-Mobility Components in Primary THA
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Serum Metal Levels, Specifically Cobalt, Chromium, and Titanium
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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.
Detailed Description
Prosthetic dislocation following total hip arthroplasty (THA) remains a significant concern with a reported incidence of 0.2%-7.0% after primary and 10%-25% after revision THA. The risk of dislocation...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2036
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03371212
Start Date
December 15 2017
End Date
December 1 2036
Last Update
January 8 2026
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612