Robotic-Assisted Versus Conventional Total Knee Arthroplasty: A Randomized Controlled Trial With 2-Year Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- IKDC
研究概览
简要总结
To evaluate whether patients undergoing robotic-assisted TKA achieve better clinical-functional, radiological, and satisfaction outcomes compared with those undergoing the conventional technique, and whether operative time and complications do not increase significantly
详细描述
To compare clinical, functional, quality-of-life, and radiological outcomes between robotic-assisted total knee arthroplasty (RA-TKA) and conventional total knee arthroplasty (C-TKA).
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 54 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with knee arthropaty recquiring TKR
排除标准
- •Cognitive disease
- •Deformity greater than 15º of varus or 10º of valgus
- •Postraumatic arthritis
- •Inflamatory disease
- •Other than "Persona PS" implant design
- •Previus surgery
研究组 & 干预措施
Conventional total knee replacement
PAtietns undergoing conventional TKR
干预措施: Conventional total knee replacement (Procedure)
Robotic TKR
PAtietns undergoing robotic TKR
干预措施: Robotic TKR (Procedure)
结局指标
主要结局
IKDC
时间窗: 2 years follow up after surgery
standardized international system for documenting and evaluating knee problems. The IKDC Subjective Knee Form is a patient-reported outcome measure that was developed to assess both surgical and non-surgical outcomes across a wide range of knee conditions and treatment approaches.
次要结局
未报告次要终点
研究者
Javier Alonso
Knee Unit Surgeon
Hospital de Terrassa