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临床试验/NCT05583630
NCT05583630招募中不适用

Ligament Tension Measurement in Knee Arthroplasty

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
110
试验地点
1
主要终点
Pre-operative knee function

研究概览

简要总结

  1. To develop a new type of knee joint pressure detection device and demonstrate its feasibility
  2. To analyze individual differences of knee ligament tension using the new device and explore the influencing factors of ligament tension
  3. To explore the correlation between knee ligament tension and postoperative knee function

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receiving primary knee arthroplasty

排除标准

  • Patients having had a surgery history of the ipsilateral knee

结局指标

主要结局

Pre-operative knee function

时间窗: 1day before operation

Assess the knee function using AKS (The American knee society, 0\~200, higher scores mean a better outcome) scale before operation

Post-operative knee function

时间窗: The 12th month after operation

Assess the knee function using AKS scale at the 12th month post-operation

Ligament tension

时间窗: During operation

Measure the medial and lateral ligament tension of the operative knee at different flexion angle

次要结局

  • Pre-operative infection test(1day before operation)
  • Post-operative infection test(The 1st day after operation)

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xu Zhihong

Professor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (1)

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