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临床试验/NCT02974205
NCT02974205招募中不适用

Kneelaxity and Self-reported Knee Function After Rehabilitation With the Use of Dynamic Kneeorthosis for Patients With Acute Isolated Posterior Cruciate Ligament Injury: A Randomized Controlled Trial

Oslo University Hospital4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016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
发起方
入组人数
80
试验地点
4
主要终点
PCL stress-radiograph

研究概览

简要总结

The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are varying. The purpose of the study is to explore if one rehabilitation option is preferable to one other for patients with acute PCL injury, by examining whether there will be differences in laxity in the knee joints and patient-reported knee function by three different rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be followed up 3 and 12 months after injury. The groups will be compared using kneelaxity (stress - X) and subjective knee function (KOOS, IKDC-2000)

详细描述

The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are varying. The purpose of the study is to explore if one rehabilitation option is preferable to one other for patients with acute PCL injury, by examining whether there will be differences in laxity in the knee joints and patient-reported knee function by three different rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be followed up 3 and 12 months after injury. The groups will be compared using kneelaxity (stress - X) and subjective knee function (KOOS, IKDC-2000) to indicate whether one rehabilitation alternative is preferable in terms of less knee joint laxity and improve knee function. Participants considered included in the study if he or she agrees to participate in the study by signing the informed consent. Inclusion criteria will be whether the patient has an acute isolated PCL injury. Exclusion is additional injuries of ligaments, cartilage and meniscus of the knee. Randomization to groups is done continuously.

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
None

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Acute isolated PCL injury : 0- 3 weeks ( maximum 21 days) from the initial injury
  • Isolated PCL rupture (grade I, II and III)
  • Patient age should be between 16-60 years ( with closed epiphyseal plate )
  • Understood and accepted written consent

排除标准

  • Injury to the ACL or other ligaments in the knee
  • Extensive injury to the cartilage or meniscus , requiring repairs
  • Unfit to understand or to sign consent
  • History of alcohol or drug abuse in the past three years
  • Current serious illness or injury that makes rehabilitation difficult.

结局指标

主要结局

PCL stress-radiograph

时间窗: 12 month

次要结局

  • KOOS (Knee Injury and Osteoarthritis Outcome score)(12 month)
  • IKDC-2000 (Subjective Knee Evaluation Form)(12 month)
  • One leg hop (in meters)(12 month)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ingrid Trøan

PT, MSc

Oslo University Hospital

研究点 (4)

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