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临床试验/NCT04742868
NCT04742868已完成不适用

Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.

Universidad de Granada4 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2020年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
4
主要终点
change of Isokinetic strenght test

研究概览

简要总结

The purpose of this CRT study is to compare clinical and functional outcomes of three graft types ( Quadriceps tendon with bone versus Hamstring tendon versus Quadriceps tendon without bone) for reconstration of anterior cruciate ligament among football players.

详细描述

In the previous studies patellar tendon and hamstring tendon were the most investigated graft types. While quadriceps tendon has been investigated a fewer times. And to our knowledge there is no control study that compare quadriceps tendon-patellar bone autograft with Quadriceps Autograft and Hamstring Autograft as control randomized study.

All of the patients will be examined before of the surgery and 3, 6, 12, 24 months after the surgery to compare the outcome of differnt graft types. While a secand aim of this study is to examen the effect of rehabilitation protocol on the short and long term within all of the clinical and the functional outcomes.

The rehabilitation protocol will contain one phase before the surgery and four phases after the surgery.The goal of the first phase will be pain and inflammation control, increase ROM and muscle strength will be during the second and the third phases.In the last phase all of the players have to achieve maximum muscle strength and neuromuscular control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

the researcher will evaluate each patient without knowing the type of grafting that will be applied

入排标准

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

入选标准

  • Patients with ACL injury susceptible to receive a surgical reconstruction.
  • Autograft with Hamstring tendon ,quadriceps tendon or quadriceps tendon with patellar bone.
  • Soccer player for more than 3 years.
  • Between 16 and 40 years old.

排除标准

  • Patient with previous joint injury.
  • Patient with previous surgery on the affected knee.
  • patient with previous musculoskeletal injury (4 weeks)
  • Patient with untreated chronic injury.

结局指标

主要结局

change of Isokinetic strenght test

时间窗: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery

the assessment will be made with GENU 3 dynamometer (GENU 3, Easytech, Firenze, Italy), using isokinetic parameters at angular velocities of 60°/sec (3 repetitions), 180°/sec (5 repetitions) and 300°/sec (15 repetitions) with 30 seconds of rest among these. To determine the height of the chair, the lateral femoral condyle was aligned with the rotational axis of the dynamometer. The peak torque, average torque and flexor-extensor torque rate value. Patients will be warm up in a cycle ergometer previously (5 min) and them performing mobilization exercises and stretching in lower limbs (5 min).

次要结局

  • MUSCLE ARQUITECTURE(Patients will be examined before , after 3 , 6 12 and 24 month of the surgery)
  • Single-legged hop test(Patients will be examined before , after 3 , 6 12 and 24 month of the surgery)
  • Pressure Pain Thresholds(Patients will be examined before , after 3 , 6 12 and 24 month of the surgery)
  • Visual Analogical Scale(Patients will be examined before , after 3 , 6 12 and 24 month of the surgery)
  • ANTEROPOSTERIOR LAXITY(Patients will be examined before , after 3 , 6 12 and 24 month of the surgery)
  • Tegner questionnaire(Patients will be examined before , after 3 , 6 12 and 24 month of the surgery)

研究者

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

Carolina Fernández Lao

Principal Investigator

Universidad de Granada

研究点 (4)

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