Using Losartan to Reduce Knee Scarring After Surgery

Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan

This study is testing if the medication Losartan can help people recover better from knee surgery by reducing scarring and improving movement.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Steadman Philippon Research Institute (other)
• Locations: 1 site (Vail, Colorado)
• Trial ID: NCT06108063 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Losartan in preventing arthrofibrosis following total knee arthroplasty (TKA). It is a double-blind, randomized, placebo-controlled study involving 120 patients who will be monitored for changes in knee range of motion and capsular thickening post-surgery. Participants will be randomly assigned to receive either Losartan or a placebo to assess the drug's impact on recovery outcomes. The study aims to provide insights into improving patient-reported outcomes after knee surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older scheduled for primary total knee arthroplasty.

Not a fit: Patients with inflammatory arthritis, previous knee surgeries, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery and reduced complications for patients undergoing total knee arthroplasty.

How similar studies have performed: While the use of Losartan in this context is novel, other studies have explored similar approaches to mitigate post-surgical complications with varying degrees of success.

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.

Where this trial is running

Vail, Colorado

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

Study contacts

• Principal investigator: Johnny Huard, PhD — Steadman Philippon Research Institute
• Study coordinator: Suzanne L Page, JD

Conditions: Knee Arthroplasty, Total, TKA Losartan Arthrofibrosis