NCT05442242尚未招募不适用
Unicompartmental Knee Arthroplasty vs. High Tibial Osteotomy for Medial Knee Osteoarthritis (UNIKORN): a Study Protocol of a Randomized Controlled Trial
Töölö Hospital0 个研究点目标入组 100 人开始时间: 2022年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- KOOS
研究概览
简要总结
Unicompartmental knee arthroplasty (UKA) and High Tibial Osteotomy are both valid treatment options for isolated medial knee osteoarthritis. Literature to date is lacking high grade evidence of the outcomes between these procedures. This is a study protocol for randomized controlled trial comparing UKA vs HTO in late stage medial knee 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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated KL 3-4 medial knee arthrosis
- •Varus > 3 degrees
- •Age 45-65 years
排除标准
- •Post-traumatic arthrosis
- •Arthrosis in the lateral compartment more than KL grade I in MRI
- •Post- traumatic arthrosis
- •Instability
- •Malignancy Obesity
结局指标
主要结局
KOOS
时间窗: 1- year
次要结局
未报告次要终点
研究者
Juuso Siren
Principal Investigator
Töölö Hospital
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