NCT03385759进行中（未招募）不适用
A Prospective Randomized Trial of Unicompartmental Versus Total Knee Arthroplasty for the Treatment of Medial Compartment Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 4
- 主要终点
- Knee Society Score
研究概览
简要总结
This study is a prospective, randomized trial to compare patient outcomes of unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) for the treatment of medial compartment osteoarthritis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medial compartment osteoarthritis of the knee
- •knee flexion greater than greater than 90 degrees
- •flexion contracture of less than 10 degrees
- •varus deformity < 20 degrees
- •grade IV degeneration of the medial compartment
排除标准
- •lateral compartment degenerative changes
- •previous lateral meniscectomy
- •anterior cruciate ligament deficiency
- •body mass index > 40
- •inflammatory arthritis
- •history of septic arthritis
- •hemoglobin A1c > 8.0
- •chronic liver disease
- •stage 3A or greater chronic renal disease
- •active IV drug abuse
- •patients requiring thromboembolic prophylaxis
结局指标
主要结局
Knee Society Score
时间窗: 2 years
Functional knee outcome questionnaire ranging from 0-100, with 100 being best
次要结局
- Revision(2 years)
研究者
Nancy Parks
Sr. Project Director
Anderson Orthopaedic Research Institute
研究点 (4)
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