Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty

NCT05157464 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 21-00823
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Recent research has focused on methods to mitigate scar tissue formation and arthrofibrosis following surgery in hopes that patients may attain maximal range of motion goals, avoid manipulation and secondary surgery (i.e. revision arthroplasty), and improve their function. The synovial fluid milieu has also highlighted the role of local biochemical markers that may be implicated in the development of arthrofibrosis. Losartan is an angiotensin receptor blocker with inhibitory effects on transforming growth factor beta (TGF-b), largely implicated in tissue repair and fibrosis by way of SMAD protein signaling suppression, and has been used in orthopaedic sports medicine to prevent stiffness following hip arthroscopy. To date, this has not commonly been used at NYU Langone in orthopedic surgery. The purpose of this study is to evaluate the efficacy of losartan use pre- and post-operatively on range of motion and the incidence of manipulation under anesthesia following total knee arthroplasty.

Conditions

Arthrofibrosis

Keywords

Total Knee Arthroplasty (TKA)

Outcome Measures

Primary Outcomes (2)

• Post-Operative Range of Motion (ROM)

  ROM will be reported as the degree of knee flexion.

  90 days post-surgery

• Post-Operative Rate of Manipulation under Anesthesia (MUA)

  Rate of MUA will be reported as percentage of participants that require MUA.

  90 days post-surgery

Study Arms (2)

Losartan Group

EXPERIMENTAL

Drug: Losartan

Control Group

NO INTERVENTION

No additional steps in management are required for the control arm of the study.

Interventions

Losartan DRUG

Patients in this group will receive Losartan 12.5mg orally twice daily beginning 2 weeks preoperatively and continuing for 4 weeks postoperatively. Losartan is an Angiotensin II Receptor Blocker currently used in the treatment of hypertension.

Losartan Group

Eligibility Criteria

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

You may qualify if:

• Patients are candidates for elective primary total knee arthroplasty for a diagnosis of osteoarthritis or inflammatory arthritis.
• Patients ≥18 years of age
• Patients have been medically cleared and scheduled for surgery
• Patients' primary care physician has verified that the patient can safely take the described dose of Losartan for the duration of the study period.

You may not qualify if:

• Any contraindications to Losartan
• Revision surgery
• Surgery for fracture, infection, or malignancy
• Patients with a diagnosis of post-traumatic arthritis
• Bilateral, simultaneous surgery
• Patients already taking an ACE-inhibitor or Angiotensin receptor blocker for hypertension

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Losartan

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

• Joshua Rozell, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, controlled, open label, parallel two-arm design, single-center study to compare the use of losartan in the prevention of stiffness following total knee arthroplasty.

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: September 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access upon reasonable request. Requests should be directed to daniel.waren@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)