Overview

This trial is active, not recruiting.

Condition total hip replacement
Treatment metal ion levels
Sponsor Mayo Clinic
Start date December 2013
End date May 2017
Trial size 200 participants
Trial identifier NCT02049892, 13-002050

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
metal ion levels

Primary Outcomes

Measure
Metal Ion levels
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 100 years old.

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 Exclusion Criteria: - Any other bearing surface besides metal on poly, no other joint replacements, symptomatic

Additional Information

Official title A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs/ Dual Mobility Total Hip Replacements
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.