Status:
RECRUITING
Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan
Lead Sponsor:
Steadman Philippon Research Institute
Conditions:
Knee Arthroplasty, Total
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 outco...
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 ...
Eligibility Criteria
Inclusion
- Planned primary total knee arthroplasty of a single knee;
- Male or female ≥ 18 years of age;
- 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
- Breastfeeding, pregnant, or planning to become pregnant during participation in the study;
- Diagnosed with inflammatory or other arthritis caused by autoimmune disease affecting the study knee;
- Previous knee arthroplasty on the study knee;
- Previous infection affecting the study knee;
- Planned total knee arthroplasty of contralateral knee to occur at any point during the study participation period;
- Are hypotensive as confirmed by Principal Clinical Investigator or appropriate designee;
- Planned lower extremity surgery (other than TKA in the study leg) for the duration of study participation;
- Any condition other than knee osteoarthritis that significantly impairs ability to walk or perform other activities of daily living;
- Currently taking: Losartan or other medication in the same drug class; Warfarin or related anticoagulants;
- 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);
- Allergic to any active or inactive ingredient of Losartan;
- Taking medication with known adverse Losartan interaction;
- 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.
Key Trial Info
Start Date :
March 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06108063
Start Date
March 6 2024
End Date
June 30 2027
Last Update
March 12 2024
Active Locations (1)
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1
The Steadman Clinic
Vail, Colorado, United States, 81657