Losartan to help recovery after multi-ligament knee injury
Official title: Losartan to Improve Outcomes After Multi-ligament Knee Injury
Run by Brigham and Women's Hospital · NCT06933706 · Data updated 2026-11-12
This study tests whether a 30-day course of losartan helps people who have surgery for multi-ligament knee injuries regain motion, strength, and return to duty or sport within a year.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 3 sites (Lexington, Kentucky and 2 other locations) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | September 30, 2029 |
| Study ends | September 30, 2029 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT06933706 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with a complete grade III injury of two or more knee ligaments who undergo surgical reconstruction or repair and can comply with study visits and rehabilitation.
✕Probably not a fit
People with prior ligament surgery on the involved knee, those undergoing staged procedures, pregnant women or those at increased risk for losartan-related side effects (severe renal or hepatic disease, hypotension, hyperkalemia) are unlikely to be eligible or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The LION trial is a double-blind, randomized controlled Phase 2 study that will enroll 90 patients with complete grade III injuries to two or more knee ligaments who undergo surgical reconstruction or repair. Participants are randomized to receive either losartan 25 mg daily or matching placebo for 30 days after surgery, with follow-up visits and outcomes collected through 12 months. The primary outcome is the Cincinnati Occupational Rating Scale score at 12 months, and secondary outcomes include knee range of motion, strength, imaging markers of synovitis and capsular thickening, and return-to-duty or sport rates. The trial is conducted across multiple centers including Brigham and Women's Hospital, University of Kentucky, and Walter Reed National Military Medical Center.
Why it matters
Potential benefit: If successful, a short course of losartan could reduce loss of knee motion and related complications after multi-ligament knee injury, improving functional recovery and return-to-duty or sport rates.
How similar studies have gone: Losartan has shown anti-fibrotic benefits in preclinical work and some clinical contexts, but using it specifically to improve recovery after multi-ligament knee injury is a novel, translational approach with limited prior clinical evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Allergic to any active or inactive ingredient of losartan * Pregnant, planning to become pregnant, or sexually active females choosing not to use effective means of contraception during the 30-day course of losartan * Those at increased risk of losartan related side effects including those with severe renal insufficiency, hepatic disease, hypotension, and/or hyperkalemia * Have a history of prior knee ligament surgery of the involved knee * Undergoing staged surgical procedures in the treatment of MLKI * Have a traumatic brain injury that limits their ability to participate in their postoperative care or any condition that would preclude the ability to comply with postoperative rehabilitation * Have a concomitant injury or underwent a surgical procedure that will preclude the ability to perform range of motion exercises (i.e. surgery for extensor mechanism rupture or avulsion, vascular graft surgery)
Where it's running
-
Mass General Brigham
Foxborough, Massachusetts, United States Recruiting -
University of Kentucky
Lexington, Kentucky, United States Not yet recruiting -
Walter Reed National Military Medical Center
Bethesda, Maryland, United States Not yet recruiting
Study contacts
- Principal investigator: Cale Jacobs, PhD — Brigham and Women's Hospital
- Study coordinator: Cale Jacobs, PhD
- Email: cjacobs@bwh.harvard.edu
- Phone: 508-216-1145
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.