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

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 13-002050
    NCT ID: NCT02049892
    Sponsor Protocol Number: 13-002050

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Trousdale, M.D.

Closed for enrollment

Contact information:

Jennifer Krogman

(507)538-3562

Krogman.Jennifer@mayo.edu

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CLS-20119093

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