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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-08-31

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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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

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ACL Injury ACL Reconstruction Scar Formation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Losartan

The experimental arm (Arm 1) will receive 25mg losartan daily for 3 days followed by 50 mg losartan daily for 25 days.

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

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.

Placebo

The placebo arm (Arm 2) will receive a placebo tablet with the same appearance and frequency to that of the losartan group.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

The placebo capsules will consist of microcrystal cellulose and will come in yellow and blue to appear identical to the losartan capsules.

Interventions

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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.

Intervention Type DRUG

Placebo

The placebo capsules will consist of microcrystal cellulose and will come in yellow and blue to appear identical to the losartan capsules.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Must be undergoing a primary ACLR with or without the following:
* Chondroplasty
* Synovectomy
* Loose body removal
* Removal of hardware
* Meniscal surgery (excluding meniscal allograft transplantation/MAT)
* Lateral extra-articular tenodesis
* Must have skeletal maturity in the distal femur and proximal tibial physes
* Must be age 18 years or older at time of enrollment

Exclusion Criteria

* \<18 years at time of enrollment
* No diagnosis of ACL tear
* ACL repairs
* Revision ACL reconstructions
* Open distal femur or proximal tibia physes
* Major concomitant procedures (such as osteotomy, MAT, or cartilage restoration surgery)
* History of prior proximal or distal femur fracture (including those receiving nonoperative treatment)
* History of prior ipsilateral femur or tibia osteomyelitis
* Medical history
* History of hypotensive disease, including postural orthostatic hypotension syndrome (POTS), autonomic dysreflexia, or Shy-Drager syndrome (aka multiple system atrophy), baseline hypotension \<90 systolic or \<60 diastolic mmHg.
* History of significant hepatic disease (liver transplantation, cirrhosis of any cause, or any liver disease with Child-Pugh classification B or C) due to hepatic metabolism of ARBs.
* Chronic kidney disease
* Rheumatologic disorders on immunologic medications
* Current medications including diuretics (i.e. furosemide), lithium, and spironolactone
* Current hypertension with prescription of an ARB or ACE-I
* Allergy to losartan
* Current pregnancy or breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No