Forgotten Joint Score After Reversed Gap Technique vs. Gap Technique
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Forgotten Joint Score 12
研究概览
简要总结
A new operation technique was established ("reversed gap technique" for implantation of total knee arthroplasties. Based on the encouraging results of a pilot study, the clinical outcome shall be evaluated using the conventional "gap technique" as control in a RCT study.
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
- Double (Participant, Outcomes Assessor)
盲法说明
neither the participant nor the outcome assessor know the group. The surgeon of course knows.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indication for implantation a total knee arthroplasty
排除标准
- •indication for a constrained implant
- •secondary type of arthritis (rheumatoid, post traumatic, post infectious)
- •former "open" surgery on the joint using an arthrotomy or HTO (arthroscopy excluded)
研究组 & 干预措施
TKA by reversed gap technique
new operative technique of positioning the femoral and tibial component based on soft tissue tension and femoral 3D geometry.
干预措施: TKA (Procedure)
TKA by gap technique
standard operative technique serving as control. tibia component positioning according to the mechanical axis, femoral component positioning according to the mechanical axis and soft tissue tension in flexion
干预措施: TKA (Procedure)
结局指标
主要结局
Forgotten Joint Score 12
时间窗: one year after operation
clinical score
次要结局
未报告次要终点
研究者
Georg Matziolis
Director of the Orthopaedic Department
University of Jena