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Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound

2021年6月19日 更新者:ahmed m. samy、Tanta University

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

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

研究概览

详细说明

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

研究类型

观察性的

注册 (实际的)

91

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 50年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

a prospective randomized control study

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
percutaneous repair with an intraoperative assissted ultrasound
a radiologist did an intraoperative ultrasound before the repair for identification the course of sural nerve and outline the medial and lateral edges of torn tendon.
Under general or regional anesthesia, the patient laid in prone position In group A, an intraoperative ultrasound was done by a radiologist before the repair .
percutaneous repair without an intraoperative assissted ultrasound
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
For patients in group B, the course of the sural nerve was determined according to the technique described by Blackmon et al.The medial and lateral borders of both stumps were outlined by palpation with identification of the gap in-between. We used the technique described byMaffulli et al with six stab incisions, one cm each. Four incisions were on medial and lateral edge of the proximal stump and the other two were around distal stump.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
American Orthopedic Foot and An¬kle Society score
大体时间:4 years
score from 0 to 100 with highest score is better
4 years
single leg rising
大体时间:3 years
ability to stand on one leg
3 years
magnetic resonance image
大体时间:one year
assessment of healing of torn tendon
one year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年5月1日

初级完成 (实际的)

2020年3月1日

研究完成 (实际的)

2020年12月1日

研究注册日期

首次提交

2021年5月27日

首先提交符合 QC 标准的

2021年6月19日

首次发布 (实际的)

2021年6月22日

研究记录更新

最后更新发布 (实际的)

2021年6月22日

上次提交的符合 QC 标准的更新

2021年6月19日

最后验证

2021年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Tanta H

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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