Delayed Loading Following Repair of a Ruptured Achilles Tendon - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Heel-rise test
研究概览
简要总结
The purpose of the study is to investigate if delayed loading following surgical treated Achilles tendon rupture influence the clinical outcome and muscle and tendon structure after one year.
The investigators hypothesize that delaying the gradual introduction of loading in the initial 26 weeks may reduce the heel-rise deficit (primary outcome) and thus improve the clinical outcome one year after surgery (primary endpoint).
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)
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
- •Diagnosed with a traumatic, complete mid-substance Achilles tendon
- •No contraindications for MRI
- •Presented within 14 days from injury
- •Adult (18 to 60 years)
- •Understand Danish
- •Manage transport to/from the hospital on their own
排除标准
- •Other injuries affecting their lower limb functions
- •Prior Achilles tendon Rupture
- •Systemic diseases influencing tendon healing
- •Anticoagulation treatment
- •Inability to follow rehabilitation or complete follow-ups
- •Immunosuppressive treatment including systematic corticosteroid treatment
研究组 & 干预措施
Early mobilization (loading)
This constitutes the currently accepted regime and is therefore considered the control group.
Cast/orthopedic boot for 6 weeks No weight bearing: week 0-2 Partiel weightbearing from week 3 Full weightbearing from week 7 ROM exercises 5 times a day from week 3
干预措施: Rehabilitation (physiotheraphy) (Other)
Delayed mobilization (loading)
Loading of the Achilles tendon is delayed for 6 weeks. Cast/orthopedic boot for 12 weeks No weight bearing: week 0-6 Partiel weightbearing from week 7 Full weightbearing from week 13 ROM exercises 5 times a day from week 3
干预措施: Rehabilitation (physiotheraphy) (Other)
结局指标
主要结局
Heel-rise test
时间窗: One-year follow-up
Heel-rise height deficit on the injured side relative to the uninjured side
次要结局
- Tendon length and cross-sectional area(1 week, 3 months, 6 months and 1 year)
- The Achilles tendon rupture score (ATRS)(Recall before injury and 1 year)
- Muscle fascicle length and doppler activity in the tendon(2 weeks, 3 months, 6 months and 1 year)
- Isokinetic plantar flexion muscle strength(1 year)
- Physical activity level(Recall before injury and 1 year)
- Heel-rise work(6 months and 1 year)
- The Achilles tendon resting angle (ATRA)(2 weeks, 3 months, 6 months and 1 year)
研究者
Rikke Høffner
PhD student, MSc, PT
Bispebjerg Hospital