跳至主要内容
临床试验/NCT04556812
NCT04556812Unknown不适用

Adults Habitual Patellar Dislocation:a Multiple-center Clinical Investigation Regarding Diagnosis and Therapeutic Strategy

Hui Zhang0 个研究点目标入组 120 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
主要终点
quadriceps strength

研究概览

简要总结

Adult habitual dislocation of the patella is a common dislocation of the patella. The range of lesions is wide and the severity is high. Clinical diagnosis and treatment are difficult. In clinical work, misdiagnosis and treatment are not targeted at pathological mechanisms. This leads to irregular diagnosis and treatment, high failure rate and revision rate, and patients undergoing multiple operations. The project team developed a "four-in-one" surgical technique centered on "tibial tuberosity osteotomy and proximal displacement" in the preliminary research, which overcomes the disadvantages of traditional knee extension surgery and is suitable for adults. Early research Shows safe and effective clinical efficacy. The purpose of this application project is to take independent innovation of core surgical technology as the lead, adopt a two-way cohort study method, compare the clinical efficacy of the new "four-in-one" technology and traditional soft tissue surgery in the treatment of adult habitual patellar dislocation, and analyze and formulate adult habituation Comprehensive and systematic solutions for patella dislocation, relying on this scientific research project to conduct multi-center and large-sample clinical case studies, and evaluate the effectiveness and safety of independent innovative technologies through standardized medical research methods to improve the surgical treatment of adult habitual patella dislocation Success rate, reduce recurrence rate and failure rate, improve the level of clinical treatment of the disease, and finally put forward a special clinical diagnosis and treatment system for the disease in the international academic community.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with habitual dislocation of the patella over 14 years old
  • agree to participate in the study

排除标准

  • Combined with other knee ligament injuries
  • recurrent patellar dislocation
  • Skin and soft tissue conditions do not allow surgery

结局指标

主要结局

quadriceps strength

时间窗: 1 year postoperatively

quantify the quadriceps strength using Biodex®

Kujala score

时间窗: 1 year postoperatively

A functional score used to assess the knee function

次要结局

未报告次要终点

研究者

发起方
Hui Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hui Zhang

Doctor of Sports Medicine Service of Beijing Jishuitan hospital

Beijing Jishuitan Hospital

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