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前瞻性随机临床试验比较急性跟腱断裂的开放性手术、微创手术与保守治疗。

Prospective randomized clinical trial of open operative, minimally invasive and conservative treatments of acute Achilles tendon tear.

机构信息

Department of Foot and Ankle Surgery, Berufsgenossenschaftliche Unfallklinik Frankfurt am Main, Friedberger Landstr. 430, 60389, Frankfurt am Main, Germany.

Department of Trauma and Orthopaedic Surgery, Evangelical Hospital Bethel Bielefeld, Bielefeld, Germany.

出版信息

Arch Orthop Trauma Surg. 2021 May;141(5):751-760. doi: 10.1007/s00402-020-03461-z. Epub 2020 May 4.

DOI:10.1007/s00402-020-03461-z
PMID:32367375
Abstract

INTRODUCTION

The acute Achilles tendon rupture (AATR) is a common injury of great importance in an increasingly active society. When early functional treatment is established, recent literature shows comparable rates of re-rupture in conservative and surgical treatments of AATR. However, there is no study comparing the outcome using a dynamometer. The aim of this study is to evaluate the results of patients with AATR treated conservatively and surgically using a dynamometer. In addition, the data are compared to evaluation of the Achilles tendon with ultrasound.

MATERIALS AND METHODS

Between 2012 and 2015, 90 patients (mean age 41 years, male-to-female ratio 81:9) with AATR were enrolled in a prospective, randomized, and monocentric study. Thirty patients were assigned to each of the three different treatment groups. Group OPEN received a conventional open suture of the Achilles tendon, group MIN received a minimally invasive suture and patients in group CONS were treated conservatively. Follow-up treatment was the same for all patients regardless of the group they were assigned to. Plantar flexion force was assessed using a dynamometer (Biodex® System 3 Pro, Biodex Medical Systems). Further evaluation included a physical test and ultrasound of the Achilles tendon.

RESULTS

Sixty-nine patients were available for a 24-month follow-up. In each of the OPEN and MIN groups, there was one re-rupture. In the CONS group, there were two re-ruptures. A positive correlation between the Biodex® dynamometer measurement and the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score (AOFAS-AH) could be found in all groups. Nevertheless, there were no significant differences between the treatment groups after 2 years. On sonography, all patients showed isolated structure loosening and a significantly thickened cross-sectional area compared with the non-injured opposite side, without differences between the groups. There was no correlation between the Biodex® measurement and sonographic outcome.

CONCLUSION

At 24-month follow-up, no significant difference can be found in patients with AATR treated operatively or conservatively. It is, therefore, important to inform patients with AATR regarding the respective advantages and disadvantages of the individual treatment strategies.

LEVEL OF EVIDENCE

Randomized controlled trial; level 1.

摘要

简介

急性跟腱断裂(AATR)是一种常见的损伤,在日益活跃的社会中具有重要意义。当确立早期功能治疗时,最近的文献显示保守治疗和手术治疗 AATR 的再断裂率相当。然而,目前尚无使用测力计比较结果的研究。本研究旨在使用测力计评估保守和手术治疗 AATR 的患者的结果。此外,将数据与超声评估跟腱进行比较。

材料和方法

2012 年至 2015 年,90 名(平均年龄 41 岁,男女比例 81:9)急性跟腱断裂患者参与了一项前瞻性、随机、单中心研究。将 30 名患者分配到三个不同的治疗组中的每组。开放性组(OPEN)接受传统的跟腱开放性缝合,微创组(MIN)接受微创缝合,保守治疗组(CONS)患者接受保守治疗。无论他们被分配到哪个组,所有患者的后续治疗都是相同的。使用测力计(Biodex® System 3 Pro,Biodex Medical Systems)评估跖屈力。进一步的评估包括物理测试和跟腱的超声检查。

结果

69 名患者可进行 24 个月的随访。开放性组和微创组各有 1 例再断裂,保守组有 2 例再断裂。在所有组中,Biodex®测力计测量值与美国矫形足踝协会踝关节-后足评分(AOFAS-AH)之间存在正相关。然而,2 年后各组之间没有显著差异。在超声检查中,所有患者均显示出孤立的结构松动和横截面积明显增厚,与未受伤的对侧相比,各组之间没有差异。Biodex®测量值与超声结果之间没有相关性。

结论

在 24 个月的随访中,手术或保守治疗的 AATR 患者之间没有发现显著差异。因此,告知 AATR 患者各自治疗策略的优缺点非常重要。

证据水平

随机对照试验;一级。

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