Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Knee Arthroplasty, Total

In brief

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.

Key facts

Study ID

NCT06108063

Run by

Steadman Philippon Research Institute

People needed

120

Starts

2024-03-06

Expected to finish

2027-06-30

Last updated by the study team

2024-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Steadman Clinic — Vail, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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