跳至主要内容
临床试验/NCT05243134
NCT05243134招募中不适用

The Influence of Anatomic Deformities on the Clinical Efficacy in the Patients With Patellar Dislocation

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
International Knee Documentation Committee(IKDC) score

研究概览

简要总结

All the data of patients with patellar dislocation will be collected to evaluate the anatomic deformities. The data includes X-ray, CT, MRI examinations, medical records, and physical examination information. Finally, we correlate the anatomic deformities with clinical efficacy. To search for the risk factors that lead to patellar dislocation and influence the therapeutic effect.

研究设计

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

入排标准

年龄范围
14 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with patellar dislocation.

排除标准

  • Patients with significant ligamentous knee injury.
  • Previous fracture or surgery of the lower limb.
  • Patellar dislocation caused by car accidents or other high-energy force directly on the patella.

结局指标

主要结局

International Knee Documentation Committee(IKDC) score

时间窗: Three years after surgery

The entire IKDC form, which includes a demographic form, current health assessment form, subjective knee evaluation form, knee history form, surgical documentation form, and knee examination form, may be used as separate forms. The knee history form and surgical documentation form are provided for convenience. All researchers are required to complete the subjective knee evaluation and knee examination form. Instructions for scoring the subjective knee evaluation form and the knee examination form are provided on the back of the forms. Total score 100, ≥75 being considered excellent.

Number of participants with redislocation of their patella after surgery as confirmed by clinical physical examination

时间窗: Three years after surgery

We can determine patellar redislocation by physical examination. In participants with redislocation of their patella, the patella (kneecap) slips out of its normal position. Often the knee is partly bent, painful and swollen.The patella is also often felt and seen out of place. We recored the number of participants with redislocation of their patella after surgery.

Magnatic Resonance Imaging evaluation

时间窗: Three years after surgery

All patients undergoing anterior cruciate ligament reconstruction underwent MRI imaging evaluation of both knees. Use International Cartilage Repair Society(ICRS) score to evaluate, total score is 12, classified into four grades,grade Ⅰ: normal (12), grade Ⅱ: nearly normal (8-11), grade Ⅲ: abnormal (4-7), grade Ⅳ: severely abnormal (1-3).

次要结局

  • Skeletal force line and various angles by X-ray evaluation(Preoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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