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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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242