Clinical Trials Logo

Clinical Trial 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 influence of stemmed tibial components versus non-stemmed tibial components on varus collapse and aseptic loosening, a consequence of implant micromotion.


Clinical Trial 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 the degree of influence of stemmed tibial components versus non-stemmed tibial components on varus collapse and aseptic loosening, a consequence of implant micromotion. Female patients with BMI of 35 kg/m2 and above will be randomized into two groups: the non-stem tibial component (control group) and the stem tibial component (treatment group). Previous studies done in the past in normal weight patients showed that there is little or no advantage in using the stem tibial implants over the non-stem ones. Theoretically, biomechanical studies have suggested that there may be improved fixation and load distribution with the use of stem tibial implants. Thus, it is necessary to see if there is any difference between both implant options among female patients who have the highest incidence of varus collapse. In terms of design, the stem tibial implants are slightly longer than the non-stem ones. They are designed to extends deeper into the tibia to enhance fixation and improve load distribution. The use of either stem tibial implants is usually based on patients' characteristics and surgeons' preference. Following informed consent, standard perioperative patient-reported metrics will be collected (Knee Injury and Osteoarthritis Outcome Score for Joint Replacement [KOOS-JR], American Knee Society score, and Patient-Reported Outcome Measurement Information System 10 [PROMIS-10]) before surgery and after surgery (6 weeks, 12 weeks, 1 year, 2 years, 3 years, and 5 years). After surgery, study participants will receive routine surgical care which includes two knee radiographs at 12 weeks and one year. In addition to this, the study participants will be evaluated at 2 years, 3 years, and 5 years postoperative periods where they will complete routine PROMs as listed above and have knee radiographs during each visit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06019832
Study type Interventional
Source University of Iowa
Contact Jacob Elkins, MD, PHD
Phone +1 319 335 7529
Email jacob-elkins@uiowa.edu
Status Recruiting
Phase N/A
Start date September 8, 2023
Completion date July 19, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2
Completed NCT05040971 - Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes Phase 3