Obesity Clinical Trial
Official title:
Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty
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 influence of stemmed tibial components versus non-stemmed tibial components on varus collapse and aseptic loosening, a consequence of implant micromotion.
Status | Recruiting |
Enrollment | 54 |
Est. completion date | July 19, 2025 |
Est. primary completion date | July 19, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Jacob M. Elkins |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Varus Collapse | The investigators will track rate of varus collapse. | up to 5 years post surgery | |
Primary | Aseptic loosening | The investigators will track rates of aseptic loosening. | up to 5 years post surgery |
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