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临床试验/NCT06379308
NCT06379308招募中不适用

Anterior Cruciate Ligament (ACL) Revision Surgery: French National Study

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年1月1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
300
试验地点
1
主要终点
Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI)

研究概览

简要总结

This is a national multicentric study led by the French Arthroscopy Society (SFA) evaluating clinical practice in anterior cruciate ligament (ACL) revision surgery (epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication rates).

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with an anterior cruciate ligament (ACL) revision, defined as "all surgical procedures involving replacement of the anterior cruciate ligament (ACL) graft with a new graft".

排除标准

  • multil-igament injuries
  • any procedure where the ACL was not revised and where any additional graft was inserted
  • Patients who had already undergone their first revision anterior cruciate ligament (ACL) procedure

结局指标

主要结局

Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI)

时间窗: Months: 0, 6, 12 and 24

Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI) will be analyzed. questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI) has 12 questions (min = 0, max = 100). Greater psychological preparation is indicated by higher scores.

Results of Functional score questionary Tegner Activity Scale (TAS)

时间窗: Months: 0, 6, 12 and 24

Results of Functional score questionary Tegner Activity Scale (TAS) will be analyzed. The Tegner Activity Scale (TAS) is a scale of sporting and professional physical activities: from 0 (professional disability due to knee) to 10 (competitive sport such as soccer or rugby at national or international level).

Results of Functional score questionary Simple Knee Value (SKV)

时间窗: Months: 0, 6, 12 and 24

Results of Functional score questionary Simple Knee Value (SKV) will be analyzed. Scale from 0 to 100 to evaluate the knee function in daily life (0 is no function and 100 is normal function)

Results of Functional score questionary International Knee Documentation Commitee (IKDC)

时间窗: Months: 0, 6, 12 and 24

Results of Functional score questionary Knee Documentation Commitee (IKDC) will be analyzed. Subjective evaluation of the knee function (from 0 to 100%, 0 is no function and 100 is normal function)

次要结局

  • Surgical complications(From surgery to 2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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