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临床试验/NCT04935281
NCT04935281已完成不适用

Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound: Does it Improves the Results of Repair?

Tanta University0 个研究点目标入组 91 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
91
主要终点
American Orthopedic Foot and An¬kle Society score

研究概览

简要总结

This is a prospective randomized controlled study carried out between May 2016 and December 2020. It included 98 patients presented with acute rupture of Achilles tendon The patients were randomly distributed by closed envelop technique (49 in each group). Group A included those managed with the assistant of an intra-operative ultrasound. Group B included those done without ultrasound assistant

详细描述

A preoperative prophylactic dose of antibiotic was given intravenously in the form of 2gm of cephalosporin one hour before operation. Under general or regional anesthesia, the patient laid in prone position without a tourniquet and both feet out of the table for easily mobilization of the ankle joint. In group A, an intraoperative ultrasound was done by a radiologist before the repair for identification the course of sural nerve and outline the medial and lateral edges of torn tendon. Then ultrasound was repeated after repair for confirmation of adequate contact of both stumps and satisfactory strength of the repair by visualization of the tendon with passive motion of the ankle. For patients in group B, the course of the sural nerve was determined according to the technique described by Blackmon et al. This technique depends on the leg length for location the point where the nerve crosses the lateral edge of the tendon. The medial and lateral borders of both stumps were outlined by palpation with identification of the gap in-between. The technique of repair was standardized for all patients in both groups. We used the technique described by Maffulli et al

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age between 18 and 50 years
  • acute ( not more than two weeks) closed complete injury
  • injury of Achilles tendon in zone 2 (the area between 3 and 6 cm from the insertion) according to Langergran and Lindholm

排除标准

  • incomplete injury
  • recurrent injury
  • associated fracture ankle or foot
  • previous history of local corticosteroids injection
  • patients with neurovascular problem (e.g. diabetic, autoimmune ...etc), smoking, and alcoholics

结局指标

主要结局

American Orthopedic Foot and An¬kle Society score

时间窗: 4 years

score from 0 to 100 with highest score is better

single leg rising

时间窗: 3 years

ability to stand on one leg

magnetic resonance image

时间窗: one year

assessment of healing of torn tendon

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ahmed m. samy

assisstant professor

Tanta University

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