Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty

NYU Langone Health

Status and phase: Withdrawn; Phase 4

Conditions: Arthrofibrosis

Treatments: Drug: Losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT05157464

21-00823

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ 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. 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

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 Group

Experimental group

Treatment:

Drug: Losartan

Control Group

No Intervention group

Description:

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