Two-layer Suturing of Achilles Tendon Ruptures - an Ambidirectional Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Tendon length
研究概览
简要总结
The purpose of the present study is to measure whether a new technique of double row suturing of a ruptured Achilles tendon will result in a normalization of the length of the Soleus part (primary outcome) and of the superficial Gastrocnemius part of the tendon (secondary outcome) one-week post-operative. Results will be compared to that of a participants group that underwent the same operation but with a standard operative technique and the same rehabilitation regime recently completed (NCT04263493).
The investigators hypothesize that the new suturing technique will result in an elongation of the Soleus part of the Achilles tendon (primary outcome) by 8.9 mm or less relative to the uninjured contralateral side one week (primary endpoint) after surgery compared to retrospective data from a recently completed randomized controlled trial
详细描述
This study is an ambidirectional cohort study with a retrospective part based on a recently completed trial (NCT04263493) and this prospective registered trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 rupture
- •Manages transportation to/from the hospital on their own
- •Presented within 14 days from injury
- •Adult (18 to 60 years)
- •Understands Danish
排除标准
- •Other injuries affecting their lower limb functions
- •Prior Achilles contralateral tendon rupture
- •Contraindications for MRI
- •Re-rupture
- •Systemic diseases influencing tendon healing
- •Anticoagulation treatment
- •Inability to follow rehabilitation or complete follow-ups
- •Immunosuppressive treatment including systemic corticosteroid treatment.
结局指标
主要结局
Tendon length
时间窗: One week after surgery.
The distance between the distal muscle fibers of the Soleus muscle and the posterior most superior part of the calcaneus.
次要结局
- Muscle cross sectional area(6 months.)
- Patient perception(12 months)
- Vascularisation(6 months.)
- Muscle architecture fascicle length(6 months.)
- Muscle architecture pennation angle(6 months.)
- Tendon length Soleus(One week after surgery.)
- Tendon length Triceps Surae(6 months.)
- Plantar flexion function(6 and 12 months.)
研究者
Anne-Sofie Agergaard
Project administrator
Bispebjerg Hospital