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OpenTrials
Completed

NCT Number: NCT02049892

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metal Ion Levels

Other

Primary outcomes

  1. Metal Ion levels

    Time frame: 2 years

    We would like to determine a difference in metal ion levels on metal on polyethylene total hip replacement

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 30, 2014
Registry last updated
Dec 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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