NCT07135687

Study to Use Oral Losartan to Decrease the Risk of Postoperative Scarring Following (ACL) Reconstruction

Oral Losartan to Decrease the Risk of Postoperative Arthrofibrosis Following Primary and Revision Anterior Cruciate Ligament Reconstruction

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study to investigate the effect of using losartan (a blood pressure lowering drug with anti-scarring properties) on preventing primary postoperative arthrofibrosis (formation of abnormal scar tissue) in the knees in participants undergoing anterior cruciate ligament (ACL) repair surgery of their knee.

Detailed description

Losartan, an angiotensin-II receptor blocker (ARB), approved by the Food and Drug Administration (FDA) for the treatment of hypertension and diabetic nephropathy, has garnered recent interest in the field of orthopedic surgery as an anti-fibrotic (anti-scarring) agent. Losartan's primary mechanism of action as an anti-hypertensive involves acting as a receptor antagonist for angiotensin II, a peptide produced by the liver which causes vasoconstriction, release of anti-diuretic hormone from the pituitary gland, and release of aldosterone from the adrenal glands, among other functions. Losartan secondary function is to act as a TGF-β1 blocker. TGF-β1 has been implicated in pro-fibrotic pathways in multiple organs systems. Losartan, initially as a treatment for hypertension and diabetic nephropathy, was found to have benefits against fibrosis in the renal system. As a result, the use of losartan has gained interest in several other fields in medicine, including plastic surgery for wound healing and keloid prevention, in ophthalmology to prevent corneal scarring, and orthopedic surgery. The potential use of losartan presents an attractive anti-fibrotic prophylaxis candidate against the formation of postoperative arthrofibrosis following ACLR.

Conditions

• ACL Injury
• ACL Reconstruction
• Scar Formation

Interventions

Type	Name	Description
DRUG	Losartan	Two types of losartan capsules will be compounded by combining a broken-up 25mg or 50mg losartan tablet and microcrystalline cellulose placebo filler to eliminate rattling of the broken tablet inside of the capsule. The 25mg losartan capsules will be yellow and the 50 mg losartan capsules will be blue.
OTHER	Placebo	The placebo capsules will consist of microcrystal cellulose and will come in yellow and blue to appear identical to the losartan capsules.

Timeline

• Start date: 2026-08-01
• Primary completion: 2028-10-01
• Completion: 2028-12-01
• First posted: 2025-08-22
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study