A Prospective Randomized Clinical Trial (RCT) Comparing Functional and Radiographic Outcomes of Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 152
- 试验地点
- 6
- 主要终点
- Radiographic Parameters
研究概览
简要总结
This study will explore if there are any difference in functional outcomes between two different surgical procedures for total knee replacement: robot-assisted versus manually-executed total knee arthroplasty.
详细描述
Although total knee arthroplasty (TKA) is an effective treatment for end-stage knee arthritis, improvements in surgical technique remain a necessity. Contemporary designs have bolstered durability, but longer life expectancies have placed an even greater emphasis on survivorship. Additionally, patient satisfaction remains an issue.
A prospective randomized clinical trial (RCT) is proposed to compare robotically-assisted versus manually executed primary (TKAs). This study is designed to address the major short-term clinically important issues between the two types of procedures with special emphasis on functional outcome. Patients will be randomized to receive either a robotically-assisted or a manually-executed primary 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
- None
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Include all patients who are surgical candidates for primary TKA with unilateral osteoarthritis
- •All eligible male or female patients between the ages of 20 years to 100 years old
- •All included study participants must be able to give an informed consent.
排除标准
- •Significant femoral or tibial deformity due to congenital or traumatic etiologies, inflammatory arthritis, post-septic arthritis, osteomyelitis, prior infection of knee joint, osteoporosis, dislocated or fragmented patella
- •The presence of infections, highly communicable diseases (e.g. AIDS), active tuberculosis, venereal disease, hepatitis.
- •Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
- •Presence of previous prosthetic knee replacement devices (of any type)
- •Metastatic disease
- •Psychiatric illness
- •Drug or alcohol abuse
- •Body mass index (BMI) > 40 kg/m2
结局指标
主要结局
Radiographic Parameters
时间窗: 1 year
Knee radiographs including an anteroposterior (AP) view and true lateral view, plus a patellar view
次要结局
未报告次要终点
研究者
Matthew P. Abdel, M.D.
Associat Professor of Orthopedics, College of Medicine
Mayo Clinic