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临床试验/NCT04037540
NCT04037540已完成不适用

Comparison of Conservative and Operative Treatment of Jones Fracture

University Hospital Ostrava2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2006年1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
发起方
入组人数
27
试验地点
2
主要终点
The American Orthopaedic Foot & Ankle Society (AOFAS) score - 6 weeks

研究概览

简要总结

The study deals with the topic of treatment of Jones fracture, comparing surgical and conservative approach. The fracture occurs especially in highly active individuals.

详细描述

The study deals with the topic of treatment of Jones fracture, comparing surgical and conservative approach. The fracture occurs especially in highly active individuals.

The study proposes a supposition of recommending the active operational approach, which shortens the period of healing by 6 weeks, limitation of physical activity by 4 weeks, and sick leave by 2 months. It also completely eliminates the need to perform a rigid fixation of the extremity for 8-12 weeks.

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

盲法说明

No masking was used in the study

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Jones fracture

排除标准

  • combined injury
  • recurring injury
  • diabetes mellitus
  • chronic renal insufficiency
  • osteopathy

研究组 & 干预措施

Operational approach

Experimental

The patients enrolled in this arm underwent surgical treatment of the Jones fracture.

干预措施: Operational approach (Procedure)

Conservative approach

Experimental

The patients enrolled in this arm were treated conservatively, using fixation of the injured extremity.

干预措施: Conservative approach (Procedure)

结局指标

主要结局

The American Orthopaedic Foot & Ankle Society (AOFAS) score - 6 weeks

时间窗: 6 weeks

The improvement in The American Orthopaedic Foot \& Ankle Society (AOFAS) score from the baseline was observed at 6 weeks after injury on a scale of 0-100.

AOFAS score - 12 months

时间窗: 12 months

The improvement in The American Orthopaedic Foot \& Ankle Society (AOFAS) score from the baseline was observed at 12 months after injury on a scale of 0-100.

次要结局

  • Signs of healing on X-ray at 6 weeks(6 weeks)
  • Signs of healing on X-ray at 12 months(6 weeks)
  • Extremity loading(6 weeks)

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (2)

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