跳至主要内容
临床试验/NCT03441659
NCT03441659招募中不适用

Anterior Cruciate Ligament Reconstruction: Clinical Outcome at Middle and Long Term Follow-Up

Stefano Zaffagnini1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2020年12月17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
Knee Laxity Assessment

研究概览

简要总结

The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1, 2 and 5 years after the intervention through a clinical visit or telephone interview. Such assessments will include the administration of questionnaires to determine the patient's functional symptoms and the objective examination of the knee during a medical examination to quantify its stability.

详细描述

The literature presents a number of studies on the reconstruction of the anterior cruciate ligament, as well as numerous registers, but the identification of factors and parameters determining the clinical outcomes remains largely debated. The study aims to offer new elements to analyze this treatment and potentially identify the factors responsible for the outcomes and the factors useful to optimize the clinical outcome in the future. In fact, in addition to collect patient data in terms of features and clinical-functional status, objective data will be documented and correlated. In particular the quantification of knee laxity will be performed using an innovative device based on the use of inertial sensors (a methodology recently developed and already validated at the Istituto Ortopedico Rizzoli). The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). These patients will be followed and evaluated preoperatively, at 6 months and at 1, 2 and 5 years after surgery during a clinical visit or a telephone interview. Such evaluations will include the submission of questionnaires to determine the patient's functional symptoms and also knee joint assessment during a medical examination to quantify the knee joint stability.

Moreover, the following clinical scores will be adopted: IKDC-subjective, IKDC-objective, SF12, Marxs, Koos, Tegner, VAS for pain assessment, EQ-VAS for overall health status assessment. Also it will be recorded the lapse of time for returning to work and sports, the degree of patient satisfaction,the adverse events, the failures and any new treatments on the same site.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have provided informed written written consent;
  • Patients aged between 18 and 60;
  • Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)

排除标准

  • Patients unable to understand and to want;
  • Patients who have not signed informed consent;

结局指标

主要结局

Knee Laxity Assessment

时间窗: 5 years

Laxity Evaluation with KiRA device

次要结局

  • VAS Score(5 years)
  • SF12 Score(5 years)
  • Marx Activity Rating Score(5 years)
  • IKDC Score(5 years)
  • KOOS Score(5 years)

研究者

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

Stefano Zaffagnini

Prof

Istituto Ortopedico Rizzoli

研究点 (1)

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