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Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty

NCT ID: NCT05157464

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-12-31

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.

Detailed Description

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Conditions

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Arthrofibrosis

Keywords

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Total Knee Arthroplasty (TKA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Losartan Group

Group Type EXPERIMENTAL

Losartan

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Losartan

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua Rozell, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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21-00823

Identifier Type: -

Identifier Source: org_study_id