Measurement of Mechanical Properties of the Healing Achilles Tendon With or Without Early Weightbearing in a Clinical Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Modulus of Elasticity
研究概览
简要总结
The purpose of this study is to measure the mechanical properties of healing Achilles tendons in humans after early controlled weightbearing, compared with a control group in a randomized, single-blinded trial. The mechanical properties are measured using radiostereophotogrammetic x-rays (RSA).
Hypothesis: Early weightbearing improves mechanical properties of the healing Achilles tendon.
详细描述
Patient with an acute Achilles tendon rupture coming to the local emergency room are asked to participate in our study. Patients have to be between 18 and 60 years and they must not have any contraindications for surgical treatment.
Patients who are interested in participating in the study receive oral and in written information about the study of the main investigator of the study (Thorsten Schepull). Patients who then agree to participate in the study are registered for surgery. All patients are operated the same way in local anaesthesia within 5 days after injury. We are going to use a conventional open technique with a dorso-medial approach. Tendon ends are going to be adapted with a resorbable suture and we are going to implant 2 Tantalum beads (size 0.8 mm) in the distal part of the tendon and 2 Tantalum beads with the same size in the proximal part. A short leg cast is going to be applied with the foot in the equinus position.
Randomization to early weightbearing or control group is done postoperatively
Group 1 (control group):
The short leg cast that is going to be applied during operation with the foot in the equinus position is removed after 3.5 weeks and a new cast is applied with the ankle in a neutral position for another 3.5 weeks. The new cast is removed after 3.5 weeks (cast treatment in total 7 weeks). Physiotherapy starts after cast removal, following our previous hospital routines. Full activity, including sports, is allowed after approximately 5 months.
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
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Achilles Tendon rupture
- •Age between 18 and 60 years
排除标准
- •Previous rupture of either Achilles tendon
- •Diabetes mellitus
- •History of cancer
- •History of Rheumatoid disease
- •Treatment with steroids
- •Any counterindication for surgical treatment
结局指标
主要结局
Modulus of Elasticity
时间窗: 7 weeks
次要结局
未报告次要终点
