Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty

NYU Langone Health

Status and phase: Withdrawn; Phase 4

Conditions: Arthrofibrosis of Knee

Treatments: Drug: Losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT06333522

23-00979

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Losartan cohort

Experimental group

Description:

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.

Treatment:

Drug: Losartan

Control cohort

No Intervention group

Description:

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.