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NCT02049892 Clinical Trial

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

Total Hip Replacement Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02049892
Other study ID # 13-002050
Secondary ID
Status Completed
Phase N/A
First received January 22, 2014
Last updated December 1, 2017
Start date December 1, 2013
Est. completion date February 1, 2016

Study information
Verified date December 2017
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date February 1, 2016
Est. primary completion date January 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Metal Ion Levels

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Metal Ion levels We would like to determine a difference in metal ion levels on metal on polyethylene total hip replacement 2 years
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