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临床试验/NCT02790346
NCT02790346已完成不适用

Interest of Talonavicular Arthrodesis on Walking Speed at Brain Lesion Patients Who Benefit of a Surgical Treatment of Ankle and Varus Foot : Randomized Study

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2015年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
walking speed at one year

研究概览

简要总结

This study should refine our surgical indications and to establish a decision tree of medical and surgical treatment of this common and troublesome strain functionally which is equino-varus.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Hemiparesis secondary to a lesion of the central nervous system, regardless of the etiology dated within 6 months
  • •Orthopedic equine-varus deformity of the foot and ankle requiring surgery
  • •Patient able to move by walking preoperatively at least 2 meters with or without technical assistance or may earn postoperative walking ability

排除标准

  • •History of foot surgery the side to be operated
  • •Significant deformation set foot and ankle (requiring treatment with triple arthrodesis)
  • •Bilateral surgery
  • •Progressive neurological disease
  • •Dystonic movements or movement disorders
  • •Realization of a botulinum toxin injection in the 6 months preceding gesture
  • •Important cognitive impairment

研究组 & 干预措施

arthrodesis talonavicular

Experimental

arthrodesis talonavicular in addition to tendon gestures

干预措施: arthrodesis talonavicular (Procedure)

arthrodesis talonavicular

Experimental

arthrodesis talonavicular in addition to tendon gestures

干预措施: tendon gestures (Procedure)

tendon gestures

Active Comparator

tendon gestures only

干预措施: tendon gestures (Procedure)

结局指标

主要结局

walking speed at one year

时间窗: 12 months after surgery intervention

次要结局

  • walking speed at 3 and 6 months(3 months and 6 months after surgery intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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