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无移位型Lisfranc损伤的手术治疗与非手术治疗:一项双中心随机临床试验

Operative versus non-operative treatment for non-displaced Lisfranc injuries: A two-center randomized clinical trial.

作者信息

Ponkilainen Ville, Mäenpää Heikki, Laine Heikki-Jussi, Partio Nikke, Väistö Olli, Jousmäki Janne, Mattila Ville M, Haapasalo Heidi

机构信息

Department of Orthopaedics and Traumatology Tampere University Hospital Tampere Finland.

Faculty of Medicine and Life Sciences University of Tampere Tampere Finland.

出版信息

Scand J Surg. 2025 Jun;114(2):153-161. doi: 10.1177/14574969241295585. Epub 2024 Nov 25.

Abstract

BACKGROUND AND AIMS

There is no consensus on which Lisfranc injuries can be treated non-operatively. The aim of the study was to compare non-operative treatment and open reduction and internal fixation (ORIF) in the treatment of non-displaced Lisfranc injuries.

MATERIALS AND METHODS

This study was a multicenter randomized controlled trial (RCT) conducted at two hospitals in Finland between 19 March 2012, and 20 December 2022, with a target sample size of 60 patients. The primary outcome was Visual Analogue Scale Foot and Ankle (VAS-FA) at 2 years. The secondary outcomes included VAS-FA pain, function, and other complaints subscales and the American Orthopedic Foot & Ankle Society (AOFAS) Midfoot Scale. All outcomes were measured at 6 months, 1 and 2 years.

RESULTS

Altogether 27 patients with computed tomography (CT)-confirmed non-displaced Lisfranc injuries were enrolled in this trial resulting in an underpowered trial. In patients with non-displaced Lisfranc injuries, the mean VAS-FA overall score in the non-operative group was 96.1 [confidence interval (CI): 91.5-100] and 91.8 [86.9-96.7] in the ORIF group at 2 years with no statistically significant difference between the groups (mean between-group difference (MD) 4.3 [CI, -2.4 to 11], Cohen's d = 0.706) in this underpowered RCT.

CONCLUSION

There was no difference in VAS-FA between non-operative and ORIF in patients with non-displaced Lisfranc injuries, but the trial is underpowered to draw robust conclusions.

摘要

背景与目的

对于哪些利氏损伤可以采用非手术治疗,目前尚无共识。本研究的目的是比较非手术治疗与切开复位内固定术(ORIF)在治疗无移位利氏损伤中的效果。

材料与方法

本研究是一项多中心随机对照试验(RCT),于2012年3月19日至2022年12月20日在芬兰的两家医院进行,目标样本量为60例患者。主要结局指标是2年时的视觉模拟量表足踝(VAS-FA)评分。次要结局指标包括VAS-FA疼痛、功能和其他主诉子量表以及美国矫形足踝协会(AOFAS)中足量表。所有结局指标均在6个月、1年和2年时进行测量。

结果

共有27例经计算机断层扫描(CT)确诊为无移位利氏损伤的患者纳入本试验,导致试验效能不足。在无移位利氏损伤患者中,非手术组2年时VAS-FA总体平均评分为96.1[置信区间(CI):91.5-100],ORIF组为91.8[8,69-96.7],在这项效能不足的RCT中,两组之间无统计学显著差异(组间平均差异(MD)4.3[CI,-2.4至11],科恩d=0.706)。

结论

在无移位利氏损伤患者中,非手术治疗与ORIF治疗在VAS-FA评分上无差异,但该试验效能不足,无法得出有力结论。

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