ROCKETS: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques in a Randomized, Multicenter, Preference-tolerant Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- The Forgotten Joint Score (FJS)
研究概览
简要总结
Rationale for conducting the study:
The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events.
Study design:
Multicentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques.
Study population:
Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study.
Number of patients:
400
Inclusion criteria:
Patients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study.
Exclusion criteria:
Patients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons.
Primary outcome variables:
The Forgotten Joint Score (FJS) at 2 years after surgery
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and older.
- •Eligible for TKR according to local guidelines and routines.
- •Willingness to participate in the study.
排除标准
- •Patients with extreme malalignment necessitating special implants or techniques.
- •Patients unfit for surgery due to other medical reasons.
- •Patients who, for other reason such as alcohol or substance abuse, is deemed unsuitable to participate in the study.
- •Patients who, for other reasons can't fulfill the required patient recorded outcome measures
结局指标
主要结局
The Forgotten Joint Score (FJS)
时间窗: 24 months post surgery
The primary outcome measurement will be the Forgotten Joint Score (FJS), measured at 24 months post-surgery. The FJS evaluates the patient's ability to 'forget' the artificial joint in their daily life. This scale ranges from 0 to 100, where 0 represents the maximum joint awareness and 100 represents complete joint unawareness, indicating that the patient does not perceive the joint during daily activities. Higher scores indicate a better outcome, reflecting the success of the knee replacement surgery in restoring natural joint function such that the joint feels like a natural part of the body.
次要结局
- KOOS(preop, 6 weeks, 12 and 24 months post surgery)
- The Forgotten Joint Score (FJS)(6 weeks and 12 months post surgery)
- EQ-5D(6 weeks, 12 and 24 months post surgery)
- ADLS knee instability(6 weeks, 12 and 24 months post-operation.)
- Knee alignment(6 weeks post surgery)
- Adverse events(up to 24 months post surgery)
研究者
Olof Skoldenberg
Professor
Danderyd Hospital