Clinical trial NCT06108063: Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan
Official title: Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Knee Arthroplasty, Total
Keywords: TKA Losartan Arthrofibrosis
Lead sponsor: Steadman Philippon Research Institute
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, double-blind, placebo controlled clinical trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Planned primary total knee arthroplasty of a single knee;
2. Male or female ≥ 18 years of age;
3. Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments.

Exclusion Criteria:

1. Breastfeeding, pregnant, or planning to become pregnant during participation in the study;
2. Diagnosed with inflammatory or other arthritis caused by autoimmune disease affecting the study knee;
3. Previous knee arthroplasty on the study knee;
4. Previous infection affecting the study knee;
5. Planned total knee arthroplasty of contralateral knee to occur at any point during the study participation period;
6. Are hypotensive as confirmed by Principal Clinical Investigator or appropriate designee;
7. Planned lower extremity surgery (other than TKA in the study leg) for the duration of study participation;
8. Any condition other than knee osteoarthritis that significantly impairs ability to walk or perform other activities of daily living;
9. Currently taking: Losartan or other medication in the same drug class; Warfarin or related anticoagulants;
10. Opioid analgesics taken in the past 8 weeks and are not willing to discontinue these medications through the duration of the study (except as prescribed as standard of care in the immediate post-operative period);
11. Allergic to any active or inactive ingredient of Losartan;
12. Taking medication with known adverse Losartan interaction;
13. Subjects that have any medical condition, including malignancies, laboratory findings, and/or findings in the medical history or in the pre-study assessments that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation, or prevent the patient from fully participating in all aspects of the study.

Primary outcomes:
measure: Quantitative Ultrasound Measurement of Capsular Thickness at Lateral Retinaculum
timeFrame: Baseline, 6 weeks post-op, and 3 months post-op
measure: Knee Range of Motion
timeFrame: Baseline, 6 weeks post-op, and 3 months post-op
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: From date of study drug dosing until the end of the study, an average of 3.5 months
measure: TGF-ß multiplex immunoassay assessment of peripheral blood plasma/serum
timeFrame: Baseline, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
measure: Flow cytometry immunosenescent phenotyping assessment of peripheral blood mononuclear cells
timeFrame: Baseline, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
measure: Knee Extensor Isometric Strength Assessment
timeFrame: Baseline, and 3 months post-op
measure: Patient Reported Outcomes Questionnaire-Numeric Rating Scale for Knee Pain
timeFrame: Baseline, day of surgery, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
measure: Patient Reported Outcomes Questionnaire-Western Ontario and McMaster Universities
timeFrame: Baseline, and 3 months post-op
measure: Patient Reported Outcomes Questionnaire-Veteran's Rand 12-Item Health Survey
timeFrame: Baseline, and 3 months post-op
Other outcomes:
Locations:
city: Vail
country: United States
facility: The Steadman Clinic
state: Colorado
Study officials:
affiliation: Steadman Philippon Research Institute
name: Johnny Huard, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Steadman Philippon Research Institute
name: Scott Tashman, PhD
role: PRINCIPAL_INVESTIGATOR
References: