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临床试验/NCT04556799
NCT04556799Unknown不适用

The Clinical Results of Derotational Osteotomy Based on 3D Osteotomy Template for Treatment of Recurrent Patellar Dislocation Combined With Patellofemoral Maltracking

Beijing Jishuitan Hospital0 个研究点目标入组 50 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
入组人数
50
主要终点
Lysholm score

研究概览

简要总结

For severe recurrent patellar dislocation with poor patellar maltracking, derotation osteotomy is an effective clinical treatment. However, derotation osteotomy requires very high requirements for the surgeon. It is necessary to determine the osteotomy surface, control the axis and complete internal fixation in three dimensions. The deviation of the osteotomy surface may cause deformities such as postoperative knee valgus, knee hyperextension, or restricted extension. The hypothesis of this study is to design a 3D osteotomy template for derotation osteotomy with the aid of computer-assisted simulated surgery. Compared with traditional osteotomy, it can effectively improve the treatment effect of recurrent patellar dislocation due to poor patellar maltracking. The incidence of postoperative knee valgus shortens the operation time and reduces the number of intraoperative fluoroscopy. This study intends to adopt a randomized controlled study, and the selection criteria are adolescent patients with recurrent patellar dislocation, aged >14 years, with a positive J sign. The experimental group used mimics 20.0 software to reconstruct the three-dimensional model of the patient based on the full-length images of the lower limbs in the weight-bearing position and the CT of the hip, knee and ankle before the operation. The osteotomy template was designed and 3D printing technology was used to make the osteotomy template for intraoperative osteotomy. The control group used traditional de-rotation techniques. The knee joint range of motion, patella stability, residual rate of J-sign, knee valgus angle, femoral anteversion angle, gait analysis, etc. were compared between the two groups after surgery, and the differences between the two surgical techniques were evaluated

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
Single (Outcomes Assessor)

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 recurrent patellar dislocation
  • >14 years old
  • positive preoperative J-sign
  • agree to participate the study

排除标准

  • Combined with other ligament injuries of knee joint
  • Skin and soft tissue conditions do not permit surgery

结局指标

主要结局

Lysholm score

时间窗: 1 year postoperatively

A function score to assess the knee function

quadriceps strength

时间窗: 1 year postoperatively

to assess the postoperative quadriceps strength using Biodex®

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hui Zhang

Doctor of Sports Medicine Service of Beijing Jishuitan hospital

Beijing Jishuitan Hospital

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