Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change in range of motion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are candidates for elective primary total knee arthroplasty for a diagnosis of osteoarthritis or inflammatory arthritis.
- •Patients ≥18 years of age
- •Patients have been medically cleared and scheduled for surgery
- •Patients' primary care physician has verified that the patient can safely take the described dose of Losartan for the duration of the study period.
排除标准
- •Patients already taking Losartan will not be included in the prospective study
- •Patients already taking an ARB (angiotensin receptor blockers) or other ACE (Angiotensin-converting-enzyme) inhibitor
- •Low blood pressure
- •Currently taking hypertensive medication
- •Revision surgery
- •Surgery for fracture, infection, or malignancy
- •Patients with a diagnosis of post-traumatic arthritis
- •Bilateral, simultaneous surgery
研究组 & 干预措施
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.
干预措施: Losartan (Drug)
结局指标
主要结局
Change in range of motion
时间窗: Baseline, Day 90
Rate of manipulation under anesthesia (MUA) after elective total knee arthroplasty
时间窗: Day 90
次要结局
未报告次要终点