Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty

Conditions
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Arthrofibrosis

Intervention / Treatment
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* Drug: Losartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Losartan Group<br> | Drug: Losartan<br>* 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.<br>|
| No Intervention: Control Group<br>No additional steps in management are required for the control arm of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty (TKA)