Losartan to help recovery after multi-ligament knee injury
Losartan to Improve Outcomes After Multi-ligament Knee Injury
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 |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 3 sites (Lexington, Kentucky and 2 other locations) |
| Trial ID | NCT06933706 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lexington, Kentucky and 2 other locations
- University of Kentucky — Lexington, Kentucky, United States (Not_yet_recruiting)
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Not_yet_recruiting)
- Mass General Brigham — Foxborough, Massachusetts, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.