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
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