Clinical trial
Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06019832
Active, not recruitingNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age40 Years to 99 Years
SexFemale
Healthy volunteersNot accepted
ConditionObesity, Aseptic Loosening, Varus Collapse
Full registry criteria
Inclusion criteria: * Female adult patients with severe osteoarthritis scheduled to have primary total knee arthroplasty * Age 40 or older * 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
Treatments and study arms
Total Knee Arthroplasty (TKA)
Procedure
Both study arms will undergo TKA
Stemmed Tibial Implant
Device
A stemmed tibial implant.
Non-stemmed tibial implant
Device
A non-stemmed tibial implant.
Primary outcomes
Varus Collapseup to 5 years post surgery
The investigators will track rate of varus collapse.
Aseptic looseningup to 5 years post surgery
The investigators will track rates of aseptic loosening.
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Iowa Health Care Medical Center North Liberty🇺🇸 North Liberty, Iowa, United States