Arthrofibrosis
Conditions
Keywords
Total Knee Arthroplasty (TKA)
Brief 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.
Interventions
DRUGLosartan
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Operative Range of Motion (ROM) | 90 days post-surgery | ROM will be reported as the degree of knee flexion. |
| Post-Operative Rate of Manipulation under Anesthesia (MUA) | 90 days post-surgery | Rate of MUA will be reported as percentage of participants that require MUA. |
Countries
United States
Outcome results
None listed