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
- 3
- 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
研究组 & 干预措施
Total Knee Robotically-Assisted
The intervention is then performed with a new device and surgical procedure. At first the femur and the tibia are fixed to the operating table with a special clamp and the knee bones are exposed with the standard technique; then the surgeon digitizes the shape of the joint and the computer transfers the planned surgical strategy to a dedicated surgical robot. Resections are performed by the surgeon on a constrained guide held by the robot.
干预措施: Total Knee Robotically-Assisted (Procedure)
Total Knee Manual-Executed by Surgeon
Your orthopaedic surgeon will remove the damaged cartilage and bone, and then position the new metal and plastic implants to restore the alignment and function of your knee.
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