Status:
NOT_YET_RECRUITING
Study to Use Oral Losartan to Decrease the Risk of Postoperative Scarring Following (ACL) Reconstruction
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
Arthroscopy Association of North America (AANA)
Conditions:
ACL Injury
ACL Reconstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ab...
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 f...
Eligibility Criteria
Inclusion
- 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
- \<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
Key Trial Info
Start Date :
August 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT07135687
Start Date
August 1 2026
End Date
December 1 2028
Last Update
December 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rush University Medical Center
Chicago, Illinois, United States, 60612