Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty

Phase 4

Withdrawn

• Conditions: Arthrofibrosis
• Interventions: Drug: Losartan

• Registration Number: NCT05157464
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-15
• Study Start: 2023-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Losartan Group	Losartan	-

Primary Outcome Measures

Name	Time	Method
Post-Operative Range of Motion (ROM)	90 days post-surgery	ROM will be reported as the degree of knee flexion.
Post-Operative Rate of Manipulation under Anesthesia (MUA)	90 days post-surgery	Rate of MUA will be reported as percentage of participants that require MUA.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States