NCT05842538招募中不适用
Robotic Assisted Surgery In Total Knee Replacement Versus Manual Total Knee Arthroplasty: A Randomized Controlled Trial
Sahlgrenska University Hospital, Sweden3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Forgotten Joint Score
研究概览
简要总结
The goal of this clinical trial is to compare robotic arm assisted surgery with manual surgery in patients operated with knee replacement.
The main aim of the study is to compare changes in joint awareness (measured by the Forgotten Joint Score.
Participants who are listed for knee arthroplasty are randomised to either robotic arm assisted surgery or manual surgery.
详细描述
Study Title:
Robotic Assisted Surgery in total knee replacement versus Manual Total Knee Arthroplasty: A randomised controlled trial
Type of study:
CE marked device study
Trial Design:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Listed for elective primary TKR for end stage osteoarthritis
- •Suitable candidate for a cruciate retaining TKR (Triathlon prosthesis)
- •Male or Female, aged 18 years or above (18-80 at the time of listing for surgery).
- •Able to understand and provide written consent.
排除标准
- •Varus deformity of > 20 degrees observed by consultant on examination
- •Patient is unable to comply with the study protocol (incl. refusal for CT scan)
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- •Requires patella resurfacing
- •Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
结局指标
主要结局
Forgotten Joint Score
时间窗: 1 year
Patient-reported outcome
次要结局
- Knee pain(2 years)
- EQ-5D(3, 12, 24 months)
- Knee Society Score(3, 12, 24 months)
- Oxford Knee Score(3, 12, 24 months)
研究者
Maziar Mohaddes Ardebili
Associate Professor
Sahlgrenska University Hospital, Sweden
研究点 (3)
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