跳至主要内容
临床试验/NL-OMON45094
NL-OMON45094已完成不适用

Acute anterior cruciate ligament rupture: RecOnsTruction Or Repair? - ROTOR study

Ziekenhuisgroep Twente0 个研究点目标入组 48 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Sportive, active patient (Tegner score =/>5)
  • - Age above 18 untill 30 years at time of inclusion
  • - Primary rupture of the anterior cruciate ligament, evidence by history (acute trauma, clicking sensation, swelling within a few hours, instability) and physical examination (positive Lachman, anterior drawer test and/or Pivot shift)
  • - Primary rupture indicated by MRI
  • - No associated ligamentuous disorde of the knee, evidenced by history, physical examination, x-ray or MRI)
  • - Time span between anterior cruciate ligament rupture and operation no longer than 21 days
  • - Willingness to comply to advised rehabilitation protocol supervised by NFVS registrated sports physiotherapist

排除标准

  • - Infection
  • - Known hypersensitive response for materials used (Cobalt, chroom, nickel)
  • - Serieus pre-existing malaligment of leg indicated for surgery
  • - Tendency for excessive scar tisseu formation, such as arthrofibrosis
  • - History of previous surgery on leg indicated for surgery
  • - History of removal of tendon on leg indicated for surgery
  • - Muscular, neurological or vascular disorders negatively affecting healing or rehabilitation
  • - Cartilage injury requiring (some kind of) cartilage repair surgery (such as microfracture or cell therapy)
  • - Arthrosis more dan ICRS grade 2 evidenced by x-ray
  • - Long(er) term use of relevant medication, such as prednisolon or cytostatica
  • - Pregnancy
  • - Know osteoporosis

研究者

发起方
Ziekenhuisgroep Twente

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