Achilles Tendon Elongation and Gait Pattern After Rupture: A Three Armed Randomized Controlled Trial Comparing an Individualized Treatment Algorithm vs. Operative or Non-operative Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Three-Dimensional Gait Analysis: Ankle peak power during push-off.
研究概览
简要总结
The objective of this study is to determine if Achilles tendon elongation and gait pattern differ between patients treated using an individualized treatment algorithm and patients treated as usual (two control groups; patients treated operatively and non-operatively).
The individualized treatment algorithm is based on ultrasonographic status of tendon overlap and Copenhagen Achilles Length Measure (1). Patients are allocated for operative treatment if there the tendon overlap is less than 25 % or the tendon is elongated with 7% or more compared to the healthy, contralateral achilles tendon.
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)
盲法说明
The posterior site of the achilles tendon region is covered by dark tape during the functional assesments.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Appointment in the Outpatients Department within 4 days of injury.
- •Total Achilles tendon rupture.
- •Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury.
- •The patient must be expected to be able to attend rehabilitation and postexamination.
- •The patient must be able to speak and understand Danish.
- •The patient must be able to give informed consent.
排除标准
- •Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
- •Previous rupture of the Achilles tendon in any of the two legs.
- •Treated with fluoroquinolones or corticosteroids within the last 6 months.
- •In medical treatment of diabetes.
- •Suffers from rheumatic disease.
- •Other conditions prior to the injury resulting in reduced function of any of the two legs.
- •Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg.
- •Inability to lie in prone position on the operating table.
- •Terminal illness or severe medical illness: American Society of Anaesthesiologists physical status classification score higher than or equal to 3.
结局指标
主要结局
Three-Dimensional Gait Analysis: Ankle peak power during push-off.
时间窗: 12 months after started treatment.
Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.
次要结局
- Balance measurement(6 and 12 months after started treatment.)
- Three-Dimensional Gait Analysis: stiffness of the plantar flexor musculo-tendinous complex during dorsiflexion.(6 and 12 months after started treatment.)
- Three-Dimensional Gait Analysis: time of heel-lift(6 and 12 months after started treatment.)
- Three-Dimensional Gait Analysis: Ankle peak power during push-off(6 months after started treatment.)
- Copenhagen Achilles Length Measure(6 and 12 months after started treatment.)
- Three-Dimensional Gait Analysis: Maximal dorsiflexion in the stance phase.(6 and 12 months after started treatment.)
- Three-Dimensional Gait Analysis: jumping up and down(6 and 12 months after started treatment.)
研究者
Maria Swennergren Hansen
Principal Investigator
Hvidovre University Hospital