Abstract：
UNASSIGNED: There is no consensus whether the primary surgical method should be open reduction and internal fixation (ORIF) or primary arthrodesis (PA) for Lisfranc injuries. The aim of our randomized controlled trial was to compare ORIF and PA for displaced Lisfranc injuries.
UNASSIGNED: This study was a national multicenter randomized controlled trial. Altogether 43 displaced Lisfranc injuries were enrolled in this trial. The primary outcome measure was Visual Analogue Scale Foot and Ankle (VAS-FA) at a 24-months follow-up. The secondary outcome measures were VAS-FA pain, function, and other complaints subscales and the American Orthopaedic Foot & Ankle Society (AOFAS) Midfoot Scale. All outcomes were measured at 6, 12, and 24 months. We were unable to reach the planned sample size of 60 patients; thus, the study remains underpowered.
UNASSIGNED: The mean VAS-FA Overall score in the ORIF group was 86.5 (95% CI 77.9, 95.1) and 80.1 (95% CI 72.0, 88.1) in the PA group at the 24-month follow-up. We did not find eligible evidence of a difference in VAS-FA Overall scores (mean between-group difference 6.5 [95% CI -5.3, 18.2], Cohen d = 0.100).
UNASSIGNED: We did not find evidence of a difference in VAS-FA between ORIF and PA in patients with displaced Lisfranc injuries, and thus both are viable options for the initial surgical method. The trial is underpowered; however, the data may be included in a meta-analysis of similarly designed randomized controlled trials.ClinicalTrials.gov identifier: NCT02953067 24 October 2016.
UNASSIGNED: This study was a national multicenter randomized controlled trial. Altogether 43 displaced Lisfranc injuries were enrolled in this trial. The primary outcome measure was Visual Analogue Scale Foot and Ankle (VAS-FA) at a 24-months follow-up. The secondary outcome measures were VAS-FA pain, function, and other complaints subscales and the American Orthopaedic Foot & Ankle Society (AOFAS) Midfoot Scale. All outcomes were measured at 6, 12, and 24 months. We were unable to reach the planned sample size of 60 patients; thus, the study remains underpowered.
UNASSIGNED: The mean VAS-FA Overall score in the ORIF group was 86.5 (95% CI 77.9, 95.1) and 80.1 (95% CI 72.0, 88.1) in the PA group at the 24-month follow-up. We did not find eligible evidence of a difference in VAS-FA Overall scores (mean between-group difference 6.5 [95% CI -5.3, 18.2], Cohen d = 0.100).
UNASSIGNED: We did not find evidence of a difference in VAS-FA between ORIF and PA in patients with displaced Lisfranc injuries, and thus both are viable options for the initial surgical method. The trial is underpowered; however, the data may be included in a meta-analysis of similarly designed randomized controlled trials.ClinicalTrials.gov identifier: NCT02953067 24 October 2016.
摘要：
■对于Lisfranc损伤，主要手术方法是否应该是切开复位内固定（ORIF）或主要关节固定术（PA）尚无共识。我们的随机对照试验的目的是比较ORIF和PA对流离失所的Lisfranc损伤的影响。
■本研究是一项国家多中心随机对照试验。该试验共纳入43例流离失所的Lisfranc损伤。主要结果指标是24个月随访时的视觉模拟足踝评分（VAS-FA）。次要结局指标为VAS-FA疼痛，函数,和其他投诉分量表和美国骨科足踝协会（AOFAS）中足量表。所有结果均在6、12和24个月进行测量。我们无法达到60名患者的计划样本量；因此，这项研究仍然动力不足。
■在24个月随访时，ORIF组的平均VAS-FA总分为86.5（95％CI77.9，95.1）和PA组为80.1（95％CI72.0，88.1）。我们没有发现VAS-FA总分差异的合格证据(组间平均差异6.5[95%CI-5.3,18.2],Cohend=0.100).
■我们没有发现在Lisfranc移位损伤患者中ORIF和PA之间的VAS-FA差异的证据，因此两者都是初始手术方法的可行选择。审判能力不足；然而，这些数据可能包括在类似设计的随机对照试验的荟萃分析中.ClinicalTrials.gov标识符：NCT029530672016年10月24日。
■本研究是一项国家多中心随机对照试验。该试验共纳入43例流离失所的Lisfranc损伤。主要结果指标是24个月随访时的视觉模拟足踝评分（VAS-FA）。次要结局指标为VAS-FA疼痛，函数,和其他投诉分量表和美国骨科足踝协会（AOFAS）中足量表。所有结果均在6、12和24个月进行测量。我们无法达到60名患者的计划样本量；因此，这项研究仍然动力不足。
■在24个月随访时，ORIF组的平均VAS-FA总分为86.5（95％CI77.9，95.1）和PA组为80.1（95％CI72.0，88.1）。我们没有发现VAS-FA总分差异的合格证据(组间平均差异6.5[95%CI-5.3,18.2],Cohend=0.100).
■我们没有发现在Lisfranc移位损伤患者中ORIF和PA之间的VAS-FA差异的证据，因此两者都是初始手术方法的可行选择。审判能力不足；然而，这些数据可能包括在类似设计的随机对照试验的荟萃分析中.ClinicalTrials.gov标识符：NCT029530672016年10月24日。
