Background: 

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.

Methods: 

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.

Results: 

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.

Conclusions: 

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.

Level of Evidence: 

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

中文翻译：

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最初的2周随访后，不进行创伤性踝关节骨折的常规X线照相不影响结果：WARRIOR试验：多中心随机对照试验。

背景： 

踝关节骨折患者常规随访X线片的临床后果尚不清楚，其有效性尚有争议。本研究的目的是确定在不影响临床疗效的情况下，是否可以省略第6周和第12周的常规X线照片。

方法： 

这项非劣效设计的多中心随机对照试验包括246例踝关节骨折患者，其中153例（62％）接受了手术治疗。在随访的6周和12周时，常规护理组（n = 128）的患者接受了常规的X光片检查，而影像学降低的组（n = 118）则没有。主要结果是Olerud-Molander踝关节评分（OMAS）。次要结果是美国骨科医师学会（AAOS）足踝问卷，以EuroQol-5 Dimensions-3水平（EQ-5D-3L）和Short-36-测量的健康相关生活质量（HRQoL）（ SF-36），并发症，疼痛，健康感知，自我感觉的恢复，X线照片的数量以及要进行X射线照片的适应症。在基线以及随访的6、12、26和52周评估结果。

结果： 

与OMAS评分相比，影像学检查的降低与常规治疗相比并不差（差异[β]，-0.9； 95％置信区间[CI]，-6.2至4.4）。两组之间的AAOS评分，HRQoL，疼痛，健康知觉和自我感觉的恢复无差异。缩小成像组的患者接受了X射线照相的中位数为4张，而常规护理组的患者接受了X射线照相的中位数为5张（p <0.05）。并发症的发生率相似（影像减少组为27.1％[118分之32]，而常规护理组为22.7％[128分之29]，p = 0.42）。并发症的类型也相似。

结论： 

在随访的第一年中，踝部骨折后实施缩小成像方案对功能结果，疼痛和并发症发生率没有可测量的负面影响。通过实施该协议可以减少后续射线照相的数量。

证据级别： 

治疗I级。有关证据水平的完整说明，请参见《作者说明》。