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

Completed

• Conditions: Total Hip Replacement
• Interventions: Other: Metal Ion Levels

• Registration Number: NCT02049892
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-30
• Primary Completion: 2016-01-01
• Study Completion: 2016-02-01
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-01
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metal Ion	Metal Ion Levels	-

Primary Outcome Measures

Name	Time	Method
Metal Ion levels	2 years	We would like to determine a difference in metal ion levels on metal on polyethylene total hip replacement

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States