Kinematics Following Total Knee Arthroplasty Performed With Different Surgical Alignment Techniques
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Knee motion, as determined by 6 degree freedom of movement kinematics and associated joint proximity during the knee bend task.
研究概览
简要总结
The purpose of this study is to evaluate and compare implant kinematics of conventional mechanically aligned and anatomically aligned total knee arthroplasties (TKA) at 1 year post-operatively.
详细描述
Participants will be randomized to receive a primary TKA using either an anatomic alignment or a conventional mechanical alignment technique.
Participants will undergo a kinematic analysis of a deep knee bend using single-plane fluoroscopy at 1 year post-operatively. The primary outcome will be based on the 6 degree of freedom kinematics and associated joint component proximity during the knee bend task. Secondary outcomes include the Knee Society Score, the Knee Injury and Osteoarthritis Outcome Score, and the Forgotten Knee Score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •Primary arthroplasty for treatment of osteoarthritis
- •Age between 40 and 80 years old
- •Willingness to provide written consent for study participation
排除标准
- •Revision arthroplasty
- •Pre-operative knee flexion lower than 90 degrees
- •Varus knee deformity greater than 15 degrees
- •Pre-operative valgus knee deformity
- •Presence of infections, highly communicable diseases or metastatic disease
- •Significant neurological or musculoskeletal disorders or disease that may interfere with normal gait or weight bearing
- •Congenital, developmental, or other bone disease or previous hip surgery that may, in the surgeon's judgment, interfere with total knee prosthesis survival or success
- •Presence of previous prosthetic knee or hip replacement device
- •BMI > 40
- •Pregnant women
研究组 & 干预措施
Anatomic alignment
The aim of anatomic alignment is to recreate an individual's pre-operative alignment using the DePuy ATTUNE total knee arthroplasty system.
干预措施: DePuy ATTUNE total knee arthroplasty system (Device)
Mechanical alignment
The aim of mechanical alignment is to achieve a neutral mechanical alignment regardless of pre-operative status, using the DePuy ATTUNE total knee arthroplasty system.
干预措施: DePuy ATTUNE total knee arthroplasty system (Device)
结局指标
主要结局
Knee motion, as determined by 6 degree freedom of movement kinematics and associated joint proximity during the knee bend task.
时间窗: 1 year post surgery
次要结局
- Knee joint and ambulatory function based on physical exam, as determined by the Knee Society Score (KSS)(1 year post surgery)
- Participants perception of knee function, as determined by the Knee injury Osteoarthritis Outcome Score (KOOS)(1 year post surgery)
- Participant's awareness of the joint implant, as determined by the Forgotten Joint Score (FJS-12)(1 year post surgery)
研究者
Kristin Zhao, PhD
Principal Investigator
Mayo Clinic