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.
■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。