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

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ClinicalTrials.gov Identifier: NCT02049892
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Robert T. Trousdale, 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.

Condition or disease Intervention/treatment
Total Hip Replacement Other: Metal Ion Levels

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Comparison of Large Diameter Metal Heads vs. Small Diameter Metal Heads vs/ Dual Mobility Total Hip Replacements
Study Start Date : December 1, 2013
Actual Primary Completion Date : January 1, 2016
Actual Study Completion Date : February 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Group/Cohort Intervention/treatment
Metal Ion Other: Metal Ion Levels



Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Orthopedic patients with prior hip replacement.
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

Exclusion Criteria:

  • Any other bearing surface besides metal on poly, no other joint replacements, symptomatic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049892


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic

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Responsible Party: Robert T. Trousdale, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02049892     History of Changes
Other Study ID Numbers: 13-002050
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017

Keywords provided by Robert T. Trousdale, Mayo Clinic:
Total Hip Replacement
Metal Ion
2-5 years after surgery
Asymptomatic