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

NCT07135687 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 24120601
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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 abnormal scar tissue) in the knees in participants undergoing anterior cruciate ligament (ACL) repair surgery of their knee.

Conditions

Scar Formation; ACL Injury; ACL Reconstruction

Keywords

ACL; Postoperative Arthrofibrosis; Losartan

Outcome Measures

Primary Outcomes (1)

• Range of Motion

  Range of motion measured from baseline to 12 months

  12 months

Study Arms (2)

Losartan

EXPERIMENTAL

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

Drug: Losartan

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Losartan 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.

Losartan

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Arthroscopy Association of North America (AANA): collaborator
• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Losartan

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Jorge Chahla, MD, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Andrew Bi, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Chahla, MD, PhD

CONTACT

(312) 432-2452; Jorge.chahla@rushortho.com

Andrew Bi, MD

CONTACT

Andrew.Bi@rushortho.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)