Closed Achilles Tendon Rupture Treats by Two Different Suture Methods and the Outcome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blood supply condition
研究概览
简要总结
The purpose of this study is to estimate the effective of two suture methods in the treatment of Achilles rupture.
详细描述
Achilles tendon rupture is one of the most common tendon injuries in the adult population. The incidence of this injury is increasing as aging adults continue their participation in high-demand sports. Although the impact of an Achilles tendon rupture is substantial, often resulting in prolonged disability and rehabilitation. Studies have showed that the operation treatment of acute Achilles tendon ruptures had some advantages. But the rebuild of blood supply was not involved in previous studies. And the epitenon of tendon is the interior layer, closest to the endotenons which contains the vascular supply. Main difference of two suture methods were if the epitenon was repaired and sewed indirectly or unrepaired and sewed directly.
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 (Participant, 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
- •Adult men or women between 18 and 60 years of age.
- •Closed rupture confirmed with ultrasound or magnetic resonance imaging (MRI).
- •Operative within 14 days after injury.
- •Willing and able to comply with and carry out the prescribed rehabilitation protocol.
- •Providing informed consent.
- •No other major trauma.
排除标准
- •Refuse to participate.
- •Refuse to participate.
- •Additional ipsilateral injury.
- •Open injury.
- •Patients not suitable for surgery (i.e., mellitus diabetes, immunocompromised states, obesity (BMI.30), peripheral vascular disease or local/systemic dermatologic disorders) or have other surgical contraindications.
- •Fluoroquinolone-associated rupture (i.e., rupture within 2 weeks after taking this medication).
- •Achilles avulsion from the calcaneus or with bone fracture.
- •Neurological or vascular disease requiring medications recognized to impair tendon healing.
结局指标
主要结局
Blood supply condition
时间窗: six weeks
Blood supply was estimated by ultrasonic contrast at six weeks after surgery.
次要结局
- Calf circumference(six weeks)
- Complications(six months)
研究者
Peifu Tang
Chief, Professor
Chinese PLA General Hospital