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临床试验/NCT00284648
NCT00284648已完成不适用

Operative Versus Non-operative Treatment of Achilles Tendon Rupture: A Multicentre, Prospective Randomized Study.

Fowler Kennedy Sport Medicine Clinic2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2000年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Re-rupture rate

研究概览

简要总结

This study is intended to determine whether the optimal treatment of acute Achilles tendon ruptures is surgical repair or functional bracing.

Our hypotheses are surgical repair will: 1) Result in a clinically relevant decrease in re-rupture rate and 2) Result in a clinically relevant improvement in disease specific quality of life and 3) A clinically relevant improvement in functional outcome measures

详细描述

Methodology This study is a multi-centre prospective randomized controlled clinical trial. This study will be conducted at five tertiary care centres by orthopaedic surgeons with an interest in soft tissue trauma. All subjects will be recruited over a one year period. Subjects who meet the following inclusion and exclusion criteria and who consent to involvement in the study will be randomized to either operative or non-operative arms of the study. All patients who enter the study will receive a pre-treatment ultrasound to document that the tear is complete and to document the location of the tear. Prior to obtaining consent for the study the risks and benefits of each treatment option will be clearly explained along with the current state of knowledge concerning treatment of Achilles tendon ruptures. It will be explained to each study participant that involvement in the study is voluntary and that they are free to discontinue their involvement at any point in their treatment .

Inclusion Criteria

  • Complete Achilles Tendon Rupture
  • Less than 7 days from date of injury
  • Age 18-70 years of age
  • Ability to follow rehab protocol

Exclusion Criteria

  • Inability to Speak English
  • Significant ipsilateral injury
  • Open injury to Achilles tendon
  • Neurological disease (ie stroke, cerebral palsy)
  • Collagen Disease (ie Ehlers Danlos disease)
  • Pregnancy
  • Fluoroquinolone associated rupture (rupture within 2 weeks of taking medication)
  • Unfit for surgery
  • Diabetes
  • Peripheral Vascular disease
  • Avulsion of Achilles tendon from calcaneus

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
Single

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

  • Complete Achilles Tendon Rupture Less than 7 days from date of injury Age 18-70 years of age Ability to follow rehab protocol

排除标准

  • Inability to Speak English Significant ipsilateral injury Open injury to Achilles tendon Neurological disease (ie stroke, cerebral palsy) Collagen Disease (ie Ehlers Danlos disease) Pregnancy Fluoroquinolone associated rupture (rupture within 2 weeks of taking medication) Unfit for surgery Diabetes Peripheral Vascular disease Avulsion of Achilles tendon from calcaneus

结局指标

主要结局

Re-rupture rate

次要结局

  • Minor complications
  • Strength Testing
  • Range of Motion, Strength and Calf Circumference
  • Major Complications
  • Disease Specific Quality of Life

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sharon Griffin

Research Coordinator

Fowler Kennedy Sport Medicine Clinic

研究点 (2)

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