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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06019832
Other study ID # 202303366
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 8, 2023
Est. completion date July 19, 2025

Study information

Verified date September 2023
Source University of Iowa
Contact Jacob Elkins, MD, PHD
Phone +1 319 335 7529
Email jacob-elkins@uiowa.edu
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Total Knee Arthroplasty (TKA)
Both study arms will undergo TKA
Device:
Stemmed Tibial Implant
A stemmed tibial implant
Non-stemmed tibial implant
non-stemmed tibial implants

Locations

Country Name City State
United States University of Iowa Hospitals and Clinics Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
Jacob M. Elkins

Country where clinical trial is conducted

United States, 

Outcome

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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