The purpose of this study is to evaluate the efficacy of Losartan use post-operatively for reducing or preventing the development of arthrofibrosis and the associated adverse impacts on clinical outcomes.
This is a double-blind, randomized, placebo-controlled clinical trial proposed to evaluate the efficacy and safety of Losartan for reducing or preventing arthrofibrosis and improving patient-reported outcomes after total knee arthroplasty (TKA). Fibrosis will be evaluated over time after TKA using measures of knee range of motion and capsular thickening. 120 patients scheduled to undergo total knee arthroplasty will be recruited from the clinical practice of the Principal Clinical Investigator or his designee at The Steadman Clinic (TSC) and randomized into one of two arms (1:1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
12.5 mg oral Losartan taken for 28 days total (4 week postoperative).
Losartan appearance-matched Prosolv EasyTab SP placebo. 12.5 mg oral tablet taken for 28 days total (4 week postoperative).
The Steadman Clinic
Vail, Colorado, United States
RECRUITINGQuantitative Ultrasound Measurement of Capsular Thickness at Lateral Retinaculum
Thickness of knee joint capsule will be measured using quantitative ultrasound. The thickness will be measured using the distance between the two bright echoes seen on the ultrasound image that correspond to the superficial and deep edges of the capsule.
Time frame: Baseline, 6 weeks post-op, and 3 months post-op
Knee Range of Motion
Reported as degree of knee Flexion/Extension
Time frame: Baseline, 6 weeks post-op, and 3 months post-op
Incidence of Treatment-Emergent Adverse Events
Occurrence of adverse events
Time frame: From date of study drug dosing until the end of the study, an average of 3.5 months
TGF-ß multiplex immunoassay assessment of peripheral blood plasma/serum
Biomarkers assessed will include quantifying secreted proteins related to inflammation, fibrosis, and senescence in the non-cellular fraction of the blood (e.g., serum and/or plasma) using commercially available immunocapture assays.
Time frame: Baseline, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
Flow cytometry immunosenescent phenotyping assessment of peripheral blood mononuclear cells
Cell types measured via flow cytometry and analyzed via immunophenotype and senescent panels.
Time frame: Baseline, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
Knee Extensor Isometric Strength Assessment
Assessed via handheld dynamometer and inclinometer containing a load cell that will digitally record the knee extension force.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, and 3 months post-op
Patient Reported Outcomes Questionnaire-Numeric Rating Scale for Knee Pain
Scale from 1-10. Higher score represents greater knee pain.
Time frame: Baseline, day of surgery, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
Patient Reported Outcomes Questionnaire-Western Ontario and McMaster Universities
Scale from 0-96. Higher score represents worse knee health.
Time frame: Baseline, and 3 months post-op
Patient Reported Outcomes Questionnaire-Veteran's Rand 12-Item Health Survey
Includes two subscales to calculate the total score. Higher score represents greater health. Scale standardized to a US Population mean of 50 and standard deviation of 10 points.
Time frame: Baseline, and 3 months post-op