Conservative vs. Operative Treatment of Achilles Tendon Rupture, Prospective Randomized Controlled Trial
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
- Subjective and objective results in conservative and operative treatment of Achilles tendon rupture.
研究概览
简要总结
The intention is to compare prospectively operative and conservative early functional rehabilitation protocol in treatment of total achilles tendon rupture. To compare these treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of motion between ankles, subjective result, isokinetic calf muscle strength). The investigators also study MRI-imaging for both legs and compare including achilles tendon elongation and muscle volume correlations to Leppilahti-score results between these two treatments. Follow-up time is 18 months.
Hypothesis is that operative treatment offers no benefit in comparison conservative treatment, with identical rehabilitation protocol.
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 (Investigator)
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
- •18-65 years, Clinical diagnosis of total achilles tendon rupture, ultrasonography controlled tendon ends reposition when ankle is in equinus/ plantar flexion.
排除标准
- •earlier achilles tendon disorders, corticosteroid injections in achilles tendon, fluorokinolol-antibiotics in 2 years earlier, systemic corticosteroid medication, diabetes, peripheral arterial disease, more than 7 days old rupture, patient lives abroad or patient refused to participate.
研究组 & 干预措施
Operative treatment
干预措施: End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture (Procedure)
conservative treatment
干预措施: Conservative treatment of achilles tendon rupture (Other)
结局指标
主要结局
Subjective and objective results in conservative and operative treatment of Achilles tendon rupture.
时间窗: 18 months
Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire. Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.
次要结局
- Complications in treatment of achilles tendon rupture.(18 months)
- Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture.(18 months)