Comparison Between Two Operational Techniques for Total Knee Replacement: A Prospective, Case Control, Double Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- PROMS
研究概览
简要总结
Advance Knee osteoarthritis is treated by Total knee replacement. Since the first TKR in 1973 there has been continuous advance in implant technology as well as operative technique, yet current patient satisfaction after the procedure is accepted to be about 80%.
There are a few operative techniques to perform TKR. Until recently the most common technique is the anterior approach to the knee and then using mechanical instrumentation to make the bone cuts for the femur and tibia. A second popular technique is the anterior approach to the knee and then using a kinematic alignment to make the bone cuts.
The investigators wish to compare short term results of the two operative techniques as evidenced in patient objective functional scores and also by evaluating the gait of the patients by using the REHAGAIT ANALYZER PRO by HASOMED inc. Magdeburg Germany.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The operative technique (Kinematic Vs. Mechanically aligned) is not revealed to the patient, investigator and outcomes assessor.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients after total knee replacement which was performed in our ward.
排除标准
- •Less than 6 months have passed after the procedure
- •Inability to understand and fill out PROMS questionnaires.
- •Inability to walk without aids for at least 20 meters.
研究组 & 干预措施
Mechanically aligned TKR
patients were operated using the standard mechanically aligned technique
干预措施: REHAGAIT ANYLIZER (Diagnostic Test)
Kinematically aligned TKR
patients were operated using the newer mechanically aligned technique
干预措施: REHAGAIT ANYLIZER (Diagnostic Test)
结局指标
主要结局
PROMS
时间窗: At least 6 months post operatively
The patients will fill out functionala and quality of life assessment questionnaires
Gait analysis
时间窗: At least 6 months post operatively
The patients will perform a gait analysis using the REHAGAIT system.
次要结局
未报告次要终点
研究者
Uriel Giwnewer
Principal investigator
HaEmek Medical Center, Israel