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临床试验/NCT01063465
NCT01063465Unknown不适用

Measurement of Mechanical Properties of the Healing Achilles Tendon With or Without Early Weightbearing in a Clinical Randomized Trial

Linkoeping University2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2009年2月1日最近更新:
适应症

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

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

研究者

发起方
Linkoeping University
申办方类型
Other Gov

研究点 (2)

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