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临床试验/NCT05893875
NCT05893875招募中不适用

Exploring the Changes of Inflammatory Factors in Joint Fluid of Patients With Sports Injury for 1-year Postoperative Rehabilitation and Clinical Treatment

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月31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
200
试验地点
1
主要终点
Tegner sacle

研究概览

简要总结

This study intends to use a prospective study design method to continuously collect immune cell and inflammatory factor data of 5ml peripheral blood and 10ml joint fluid from 200 patients who met the inclusion and exclusion criteria in our department from January 2020 to January 2022. The aim is to analyze the impact of changes in inflammatory factors before and after surgery on postoperative recovery.

详细描述

This study intends to use a retrospective study design method to continuously collect immune cell and inflammatory factor data of 5ml peripheral blood and 10ml joint fluid from 200 patients who met the inclusion and exclusion criteria in our department starting from January 2021. The aim is to analyze the impact of changes in inflammatory factors before and after surgery on postoperative recovery. The indicators of postoperative rehabilitation for patients were objectively evaluated using three scales: Lysholm scale, VAS scale, and Tegner scale. Among them, the Lysholm scale mainly evaluates the postoperative recovery of knee joint function in patients, with values ranging from 0 to 100. The higher the value, the better the recovery; The VAS scale mainly evaluates the postoperative pain score of patients, with values ranging from 0 to 10. The higher the value, the more severe the pain; The Tegner scale is also mainly used to evaluate the postoperative recovery of knee joint function in patients, with values ranging from 0 to 10. The higher the value, the better the recovery.

研究设计

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

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Those with healthy diet and regular exercise habits;
  • Sports injury patients(Satisfy one of the following conditions): Anterior cruciate ligament injury or meniscus injury

排除标准

  • Existence of underlying diseases related to the immune system;
  • Trauma leading to knee joint fracture;
  • Blood pressure, heart rate, vital capacity, muscle tension and other indicators are obviously abnormal;
  • Significant abnormalities in blood routine, infection indicators, heart, lung, liver, and kidney function tests, insufficient compensatory function of important organs, or severe systemic diseases;
  • Patients with neurological or psychiatric disorders, pregnant women, or a history of related illnesses combined with severe organic diseases

结局指标

主要结局

Tegner sacle

时间窗: Change from 6 months and 1 Year after ACLR operation

The Tegner scale is also mainly used to evaluate the postoperative recovery of knee joint function in patients, with values ranging from 0 to 10. The higher the value, the better the recovery

Visual Analog Score for pain (VAS)

时间窗: Change from 2 weeks, 1 month, 3 months, 6 months, and 1 Year after ACLR operation

The VAS scale mainly evaluates the postoperative pain score of patients, with values ranging from 0 to 10. The higher the value, the more severe the pain;

Lysholm score

时间窗: Change from 6 months and 1 Year after ACLR operation

The Lysholm scale mainly evaluates the postoperative recovery of knee joint function in patients, with values ranging from 0 to 100. The higher the value, the better the recovery;

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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