Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty

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WITHDRAWN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

2024-07-01

Study Completion Date

2026-01-01

Brief Summary

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The purpose of this study is to determine the effect of Losartan, an Angiotensin II Receptor Blocker (ARB), on the formation development of arthrofibrosis in patients who have had a primary total knee arthroplasty. This study aims to assess the post-operative range of motion and the incidence of MUA within three months following the index arthroplasty in the treatment arm (losartan) and the control arm.

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Detailed Description

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Conditions

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Arthrofibrosis of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Losartan cohort

Patients will initiate Losartan treatment 2 weeks pre-operatively and will continue until 4 weeks post-operatively. Range of motion will be measured as part of standard of care at the time of enrollment and at post-op office visits 2-4 weeks, 4-8 weeks and 8-20 weeks post-operatively.

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

Patients will receive Losartan 12.5mg orally twice daily beginning 2 weeks preoperatively and continuing for 4 weeks postoperatively.

Control cohort

No additional steps in management are required for the control arm of the study. Range of motion will be measured as part of standard of care at the time of enrollment and at post-op office visits 2-4 weeks, 4-8 weeks and 8-20 weeks post-operatively.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Losartan

Patients will receive Losartan 12.5mg orally twice daily beginning 2 weeks preoperatively and continuing for 4 weeks postoperatively.

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. Patients already taking Losartan will not be included in the prospective study
2. Patients already taking an ARB (angiotensin receptor blockers) or other ACE (Angiotensin-converting-enzyme) inhibitor
3. Low blood pressure
4. Currently taking hypertensive medication
5. Revision surgery
6. Surgery for fracture, infection, or malignancy
7. Patients with a diagnosis of post-traumatic arthritis
8. Bilateral, simultaneous surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No