Synovitis Clinical Trials

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Losartan to Improve Outcomes After Multi-ligament Knee Injury

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• Multi-ligament knee injury defined as a complete grade III injury of 2 or more ligaments

• At least one ligament surgically reconstructed or repaired

• Willingness to comply with the study protocol and assessments

Locations
United States
Kentucky
University of Kentucky
NOT_YET_RECRUITING
Lexington
Massachusetts
Mass General Brigham
RECRUITING
Foxborough
Maryland
Walter Reed National Military Medical Center
NOT_YET_RECRUITING
Bethesda
Contact Information
Primary
Cale Jacobs, PhD
cjacobs@bwh.harvard.edu
508-216-1145
Backup
Molly Zgoda
mzgoda@mgb.org
508-216-1145
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 90
Treatments
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.
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: University of Kentucky, Walter Reed National Military Medical Center

This content was sourced from clinicaltrials.gov