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临床试验/NCT07188363
NCT07188363招募中不适用

Prospective Follow-up Study of Patients Undergoing Ankle Ligament Surgery

Chirurgie Du Sport1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
1
主要终点
Recurrence of a ligament tear

研究概览

简要总结

This 20-year cohort study foolows patients after ankle ligament reconstruction surgery to evaluate re-rupture rates, long term functional outcomes, return to sport rates ans complications? The goal is to provide insights into the procedure's durability and effectiveness to enhance patient care.

详细描述

This study is a long term cohort analysis involving patient who have undergone ankle ligament reconstruction surgery (ligamentoplasty). The goal is to follow these patients over 20 year period to assess several important outcomes. Specifically, the study aims to evaluate the rate of re-ruptures, the rates and quality of return to sport, long term functional outcomes using validated scoring systems and the incidence of complications related to the procedure.

By collecting detailed and consistent data over two decades, the research seeks to provide valuable insights into the durability and effectiveness of ankle ligament reconstruction surgery, contributing to a better understanding and improved care for patients

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

入选标准

  • Retensioning, ankle ligament reconstruction or syndesmosis repair surgery

排除标准

  • Patient refusal

结局指标

主要结局

Recurrence of a ligament tear

时间窗: From the surgery to the end of the study (20years of follow-up for each patient)

次要结局

  • Return to sport(From the surgey to the end of follow up (20 years))
  • Visual Analogue Scale(From the surgery to the and of the follow-up (20 years for each patient))
  • Ankle Ligament Reconstruction - Return to Sport Injury score(From the surgery to the end of foolow-up (20 years for each patient))
  • Foot and Ankle outcome score(From the surgey to the end of follow-up (20 years of follow-up for each patient))
  • Cumberland Ankle Instability Tool (CAIT)(From the surgery to the end of the follow-up (20 years for each patient))
  • Foot an Ankle Ability Measure(From the surgery to the end of follow-up (20 years for each patient))
  • Complications(From the surgery to the end of follow-up (20 years for each patient))

研究者

发起方
Chirurgie Du Sport
申办方类型
Other
责任方
Principal Investigator
主要研究者

HARDY Alexandre

Surgeon

Chirurgie Du Sport

研究点 (1)

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