Losartan to Improve Outcomes After Multi-ligament Knee Injury

Conditions

• Multi-ligament Knee Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - 40 Years

Healthy Volunteers

Not accepted

Interventions

• losartan 25 mg — DRUG
  Losartan is an angiotensin-II inhibitor that modulates the renin-angiotensin system by blocking the activation of angiotensin type 1 receptors, thus preventing binding with angiotensin-II and decreasing blood pressure. Losartan has a broader therapeutic potential for muscle healing and treatment for diseases ranging from rheumatoid arthritis, osteoarthritis, chronic kidney disease, Marfan syndrome, and fatty liver. TGF-β plays an active role in fibrosis leading to the formation of adhesions and scar tissue. By limiting the formation of adhesions and scar tissue, losartan may reduce pain, myofibroblast activity, synovitis, fibrosis, and cartilage degeneration.
• Placebo capsule — OTHER
  The placebo capsule will look identical to the active study drug, but will not have any active ingredient and will be filled with corn starch

Study Details

Multi-ligament knee injuries (MLKIs) can occur during military training, sports injuries, or traumatic events such as motor vehicle accidents and can be devastating events. These complex injuries involving disruption of 2 or more ligaments often coincide with injuries to arteries, nerves, tendons, menisci, and/or fractures and can be devastating events. MLKIs often require complex treatments nearly 2 in 5 patients suffer complications after surgery. Loss of knee range of motion is the most common complication and is associated with military separation. There are also long-term effects of motion loss, as the need for motion-restoring surgery after MLKI is associated with an increased risk of osteoarthritis within 5 years of surgery. A person's ability to perform both activities of daily living and higher demand physical activities is often impaired both in the short and long term. In fact, only 1 in 3 people return to high-level sport after MLKI. The purpose of this translational randomized clinical trial is to determine if a 30-day course of oral Losartan improves a person's ability to return to work or sport, range of motion and strength, and reduce knee inflammation in the first year after surgical treatment of an MLKI.

Key Dates

Start date

Oct 1, 2025

Status verified

Jan 2026

Primary completion

Sep 30, 2029

Completion

Sep 30, 2029

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Losartan
  Participants randomized to the Losartan arm will be asked to take 25 mg of losartan per day for 30 days.
• Placebo Comparator: Placebo
  Participants randomized to the Placebo arm will be asked to take one placebo capsule per day for 30 days.

Primary Outcome Measure

Cincinnati Occupational Rating Scale (CORS) [ Time Frame: Baseline, 1 month, 6 months, and 12 months ]

Central Contacts

• Cale Jacobs, PhD
  508-216-1145
  [email protected]
• Molly Zgoda
  508-216-1145
  [email protected]

Locations (3)

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