Individualized Treatment for Acute Achilles Tendon Rupture Based on Barfod's Ultrasonographic Length Measure - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Heel-rise work test
研究概览
简要总结
To asses the functional outcome after individualized treatment of acute achilles tendon rupture. The treatment is individualizes on the basis of ultrasonographic status of tendon overlap and Barfod's Ultrasonographic length measure. 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.
The study includes two control groups of non-operative and operative treatment.
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
- Double (Investigator, 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 post-examinations.
- •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: ASA (American Society of Anesthesiologists) score higher than or equal to 3.
研究组 & 干预措施
Control group 1
For the patients allocated to non-operative treatment the injured leg is placed in a circulated below-the-knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle.
The patient will follow standard functional rehabilitation and the follow-up evaluations.
干预措施: Non-operative treatment (Procedure)
Individualized treatment
The ruptured achilles tendon is examined by ultrasonography. If the overlap of the tendon ends is less than 25 % or the tendon is elongated 7 % or more the patient receives conventional open operative treatment. The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anaesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below-the-knee cast after surgery. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle.
The patient will follow standard functional rehabilitation and the follow-up evaluations.
干预措施: Individualized treatment of Acute Achilles tendon rupture. (Procedure)
Control group 2
The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anaesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below-the-knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle.
The patient will follow standard functional rehabilitation and the follow-up evaluations.
干预措施: Operative treatment (Procedure)
结局指标
主要结局
Heel-rise work test
时间窗: Evaluation method after 12 months of started treatment
An endurance test where the patient stands on one leg and lifts the heel up and down until exhaustion. The number and the height of the heel rises are counted and measured and plotted into a diagram on an X-axis and Y-axis respectively. The results are then compared to the weight of the patient and the total work is estimated as area under the curve. The heel lift distance between the heel and the floor is measured in millimeters. The procedure is performed on the uninjured leg first and subsequently on the injured leg. The patient is barefoot for the heel-rise work test and stands on a flat surface with a 10 degree inclination. For these functional tests a measurement system MuscleLab (Ergotest Technology, Oslo, Norway) will be used at all the centers.
次要结局
- Barfod's ultrasonographic length measure(Evaluation method after 6 and 12 months of started treatment)
- Complications(Evaluation method after 12 months of started treatment)
- Achilles tendon Total Rupture Score (ATRS)(Evaluation method after 6 and 12 months of started treatment)
- Heel-rise Work test(Evaluation method after 6 months of started treatment)
- Indirectly, clinical Achilles tendon length estimate(Evaluation method after 6 and 12 months of started treatment)
研究者
Marianne Toft Vestermark
Head of Orthopaedic Resaerch, MD PhD
Central Jutland Regional Hospital