A New Technique to Produce Anatomical Alignment Results With Less Midflexion Instability in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Measurement of midflexion instability (i.e. tibofemoral gap medially and laterally) in 30° and 60° of flexion
研究概览
简要总结
Beside the current standard of classical mechanical alignment of total knee replacements, increased interest is being shown in anatomical alignment. However, no surgical technique is capable of controlling the stability of the joint in midflexion. The purpose of the present study was to present and evaluate a new surgical technique, which aims to reduce the need for soft-tissue release and optimize stability in midflexion.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients were to undergo surface replacement due to primary osteoarthritis of the knee
排除标准
- •Joints that had undergone open surgery beforehand (e.g. high tibial osteotomy, fracture treatment) were excluded.
研究组 & 干预措施
gap technique (GT)
The patients receive a total knee arthroplasty using the established "gap technique" (gold standard serving as control). The intervention is the implantation of a total knee arthroplasty with this specific technique.
Implantation of TKA using the gap technique is the intervention. Intervention is not a drug but a specific operative technique.
干预措施: Implantation of TKA using the gap technique (Procedure)
anatomical alignment (AA)
The patients receive a total knee arthroplasty using the new "anatomical alignment technique" (experimental). The intervention is the implantation of a total knee arthroplasty with this specific technique.
Implantation of TKA using anatomical alignment Intervention is not a drug but a specific operative technique.
干预措施: Implantation of TKA using anatomical alignment (Procedure)
结局指标
主要结局
Measurement of midflexion instability (i.e. tibofemoral gap medially and laterally) in 30° and 60° of flexion
时间窗: intraoperatively immediately before implantation of definite implants.
The outcome measures are given in mm.
次要结局
- performance of soft tissue release (yes / no) and extend of release if done.(intraoperatively)
研究者
Georg Matziolis
Prof. Dr. med.
University of Jena