Mechanical Properties in Conservative Treated Achilles Tendon Ruptures With or Without Early Controlled Loading
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 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 the tendon after conservative treated Achilles tendon ruptures with or without early controlled loading. This is done in a randomized trial and the mechanical properties are measured using roentgen stereometric analysis (RSA).
The hypothesis is that early weightbearing improves mechanical properties of conservative treated Achilles tendon ruptures without causing elongation of the tendon.
详细描述
Treatment of Achilles tendon ruptures includes surgical repair or immobilization in an orthosis, followed by prolonged rehabilitation. Improved rehabilitation regimens still display imperfect recovery, with deficits such as persistent end-range muscle weakness, tendon elongation and incomplete return to pre-injury activity level. The underlying mechanisms are unknown, but are likely to involve molecular and cellular aspects of the early healing processes. Animal experiments have shown that short episodes of vigorous loading during tendon healing create a stronger tendon, and lead to less elongation than continuous loading. Early controlled training has also been shown to improve the material properties of surgically repaired tendons. However, more and more clinics now turn away from surgery and towards conservative treatment, while studies on rehabilitation mainly concern sutured tendons. It is therefore also important to understand how to best rehabilitate conservatively treated patients. The aim is to investigate the effect of early controlled loading on conservatively treated Achilles tendon ruptures.
The patients (age 18-60 years of age) are treated conservatively by receiving a removable foam walker boot at the emergency department. The patients are thereafter called by the principal investigator and are asked if they want to participate in the study. Patients who are interested in participating in the study receive oral and in written information about the study of the principal investigator of the study (Pernilla Eliasson).
After 2 weeks, the rupture is localized by ultrasound and 4 tantalum beads are implanted percutaneously in the proximal and distal part of the tendon. These beads are used for measurements of the mechanical properties of the tendon by using RSA.
The patients are thereafter randomized to early controlled loading or control.
All patients wear the foam walker boot for 7 weeks. Full weight-bearing is allowed as tolerated from the beginning. Both groups perform motion exercises outside the boot with 20 repetitions, 3 times per day as of 14 days after rupture.
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 (Outcomes Assessor)
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
- •Complete Achilles tendon rupture placed in the mid-substance of the Achilles tendon
- •Presented within 14 days from injury
- •18-60 years old
排除标准
- •Inability to understand swedish
- •previous injured tendon
- •Diabetes mellitus
- •History of Rheumatoid disease
- •Treatment with steroids
结局指标
主要结局
Modulus of Elasticity
时间窗: 19 weeks
Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.
次要结局
- Heel-rise(19 and 52 weeks after rupture)
- Modulus of Elasticity(7 and 52 weeks after rupture)
- Plastic deformation of the tendon(7 weeks after rupture)
- Tendon elongation(2, 7, 19 and 52 weeks after rupture)
- Achilles tendon total rupture score (ATRS)(19 and 52 weeks after rupture)
- Maximal range of motion(19 and 52 weeks after rupture)
- Calf muscle circumference(19 and 52 weeks)
研究者
Pernilla Eliasson
Postdoc
Linkoeping University