Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.
Department of Surgery, Amsterdam University Medical Center, Amsterdam, the Netherlands.
J Bone Joint Surg Am. 2020 Sep 16;102(18):1588-1599. doi: 10.2106/JBJS.19.01381.
The clinical consequences of routine follow-up radiographs for patients with ankle fracture are unclear, and their usefulness is disputed. The purpose of the present study was to determine if routine radiographs made at weeks 6 and 12 can be omitted without compromising clinical outcomes.
This multicenter randomized controlled trial with a noninferiority design included 246 patients with an ankle fracture, 153 (62%) of whom received operative treatment. At 6 and 12 weeks of follow-up, patients in the routine-care group (n = 128) received routine radiographs whereas patients in the reduced-imaging group (n = 118) did not. The primary outcome was the Olerud-Molander Ankle Score (OMAS). Secondary outcomes were the American Academy of Orthopaedic Surgeons (AAOS) foot and ankle questionnaire, health-related quality of life (HRQoL) as measured with the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) and Short Form-36 (SF-36), complications, pain, health perception, self-perceived recovery, the number of radiographs, and the indications for radiographs to be made. The outcomes were assessed at baseline and at 6, 12, 26, and 52 weeks of follow-up. Data were analyzed with use of mixed models.
Reduced imaging was noninferior compared with routine care in terms of OMAS scores (difference [β], -0.9; 95% confidence interval [CI], -6.2 to 4.4). AAOS scores, HRQoL, pain, health perception, and self-perceived recovery did not differ between groups. Patients in the reduced-imaging group received a median of 4 radiographs, whereas those in the routine-care group received a median of 5 radiographs (p < 0.05). The rates of complications were similar (27.1% [32 of 118] in the reduced-imaging group, compared with 22.7% [29 of 128] in the routine-care group, p = 0.42). The types of complications were also similar.
Implementation of a reduced-imaging protocol following an ankle fracture has no measurable negative effects on functional outcome, pain, and complication rates during the first year of follow-up. The number of follow-up radiographs can be reduced by implementing this protocol.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
目前尚不清楚常规随访 X 光检查对踝关节骨折患者的临床后果，其是否有用也存在争议。本研究旨在确定在不影响临床结果的情况下，是否可以省略第 6 周和第 12 周的常规 X 光检查。
这是一项多中心、随机对照、非劣效性试验，纳入了 246 例踝关节骨折患者，其中 153 例（62%）接受了手术治疗。在 6 周和 12 周的随访时，常规护理组（n = 128）的患者接受了常规 X 光检查，而减少影像学组（n = 118）的患者则未接受。主要结局是 Olerud-Molander 踝关节评分（OMAS）。次要结局是美国矫形外科医师学会（AAOS）足部和踝关节问卷、健康相关生活质量（HRQoL），采用 EuroQol-5 维度-3 水平（EQ-5D-3L）和简明 36 健康调查量表（SF-36）进行评估、并发症、疼痛、健康感知、自我感知恢复、X 光片数量以及进行 X 光片的指征。在基线、6 周、12 周、26 周和 52 周随访时评估结局。采用混合模型进行数据分析。
在 OMAS 评分方面，减少影像学检查与常规护理相比是非劣效的（差异[β]，-0.9；95%置信区间[CI]，-6.2 至 4.4）。AAOS 评分、HRQoL、疼痛、健康感知和自我感知恢复在两组间无差异。减少影像学组的患者接受了中位数为 4 次 X 光检查，而常规护理组的患者接受了中位数为 5 次 X 光检查（p < 0.05）。并发症发生率相似（减少影像学组为 27.1%[32/118]，常规护理组为 22.7%[29/128]，p = 0.42）。并发症类型也相似。
踝关节骨折后实施减少影像学检查方案在第 1 年随访期间对功能结果、疼痛和并发症发生率没有可测量的负面影响。通过实施该方案，可以减少随访 X 光片的数量。
治疗性 I 级。有关证据水平的完整描述，请参阅作者说明。
