Status:

ENROLLING_BY_INVITATION

Analysis of Stem and Non-Stem Tibial Component

Lead Sponsor:

Jacob M. Elkins

Conditions:

Obesity

Aseptic Loosening

Eligibility:

FEMALE

50-99 years

Phase:

NA

Brief Summary

The purpose of this study is to compare rates of varus collapse, aseptic loosening, and implant failure in female obese patients undergoing total knee arthroplasty (TKA) and will review the degree of ...

Detailed Description

The purpose of this study is to identify varus collapse, aseptic loosening, and implant failure in female obese patients undergoing total knee arthroplasty (TKA). In addition, this study will review t...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Female adult patients with severe osteoarthritis scheduled to have primary total knee arthroplasty
  • 35 kg/m2 and above
  • Only patients from the PI's clinic will be included.
  • Women who are still menstruating and are currently on contraceptives and women who are in menopause.
  • Exclusion Criteria:
  • Patients who have some active local or widespread infection (including secondary or inflammatory osteoarthritis)
  • medical conditions that put them at risk of complications or death during and after the study would not be eligible for surgery
  • Patients with previous knee surgery on arthroplasty site will be excluded
  • Pregnant patients and women who are capable of getting pregnant

Exclusion

    Key Trial Info

    Start Date :

    August 14 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 31 2032

    Estimated Enrollment :

    54 Patients enrolled

    Trial Details

    Trial ID

    NCT06019832

    Start Date

    August 14 2023

    End Date

    December 31 2032

    Last Update

    December 17 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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    University of Iowa Hospitals and Clinics

    Iowa City, Iowa, United States, 52242