Operative Versus Non-operative Treatment of Achilles Tendon Rupture: A Multicentre, Prospective Randomized Study.
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
- 否
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
Sharon Griffin
Research Coordinator
Fowler Kennedy Sport Medicine Clinic
