Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty

Arthrofibrosis Clinical Trial

Official title:

Losartan Use to Mitigate Arthrofibrosis Following Total Join Arthroplasty

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05157464
• Other study ID #: 21-00823
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthrofibrosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Operative Range of Motion (ROM)	ROM will be reported as the degree of knee flexion.	90 days post-surgery
Primary	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