Analysis of Stem and Non-Stem Tibial Component
Launched by JACOB M. ELKINS · Aug 30, 2023
Trial Information
Current as of August 20, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This clinical trial is studying how different types of knee implants affect outcomes for women with obesity who are having total knee replacement surgery. Specifically, it will look at whether using a stemmed tibial component (which is part of the knee implant that goes deeper into the bone) leads to lower rates of complications such as varus collapse (which is when the knee bends inward) and aseptic loosening (when the implant becomes loose without infection). The trial aims to help understand which type of implant might work better for women facing these challenges.
To participate in this study, you need to be a female adult with severe osteoarthritis who is planning to have a total knee replacement and has a body mass index (BMI) of 35 or higher. You can be either pre-menopausal or post-menopausal, but you should not have any recent infections or previous knee surgeries on the same knee. If you join the study, you will contribute to important research that could improve knee surgery outcomes for women like you. The trial is currently recruiting participants from the clinic where the study is being conducted.
Gender
FEMALE
Eligibility criteria
- 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
About Jacob M. Elkins
Jacob M. Elkins is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on transparency, ethics, and collaboration, Mr. Elkins leads initiatives that explore new therapeutic approaches across various disease states. His extensive experience in clinical development and regulatory affairs enables the efficient design and execution of trials, ensuring adherence to the highest standards of scientific integrity and patient safety. By fostering partnerships with research institutions and healthcare professionals, Jacob M. Elkins aims to contribute significantly to the body of medical knowledge and the development of effective treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Iowa City, Iowa, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported