A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs/ Dual Mobility Total Hip Replacements

Mayo Clinic1 site in 1 country80 target enrollmentDecember 1, 2013

ConditionsTotal Hip Replacement

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Total Hip Replacement
Sponsor: Mayo Clinic
Enrollment: 80
Locations: 1
Primary Endpoint: Metal Ion levels
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Does having a large diameter metal on polyethylene total hip replacement increase metal ion release. Larger metal heads are thought to have increased torsional forces on the trunion which would like release more metal ions. Increased metal ion levels have been associated with adverse local tissue reactions. Are there any differences comparing these groups to a dual mobility type total hip replacement.

Registry

clinicaltrials.gov

Start Date

December 1, 2013

End Date

February 1, 2016

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Robert T. Trousdale

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•One total hip replacement, either a large metal head (\>40) or a small metal head (\<30) on a polyethylene bearing surface.
•2 to 5 years s/p surgery minimum. No symptoms