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切开复位与带线锚钉固定治疗Ⅲ型和Ⅳ型肩锁关节脱位的前瞻性随机对照研究:ACORN 研究。

Open Reduction and Tunneled Suspensory Device Fixation Compared with Nonoperative Treatment for Type-III and Type-IV Acromioclavicular Joint Dislocations: The ACORN Prospective, Randomized Controlled Trial.

机构信息

The University of Edinburgh, Edinburgh, United Kingdom.

Edinburgh Shoulder Clinic, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom.

出版信息

J Bone Joint Surg Am. 2018 Nov 21;100(22):1912-1918. doi: 10.2106/JBJS.18.00412.

Abstract

BACKGROUND

Nonoperative management of complete acromioclavicular (AC) joint dislocation has yielded reasonable results, although patients may report dissatisfaction with the outcome. The purpose of this prospective, randomized, controlled trial was to compare patient outcome following nonoperative care versus operative treatment with open reduction and tunneled suspension device (ORTSD) fixation for acute, type-III or IV disruptions of the AC joint.

METHODS

Sixty patients aged 16 to 35 years with an acute type-III or IV disruption of the AC joint were randomized to receive ORTSD fixation or nonoperative treatment, following a power analysis to determine sample size. Functional outcomes were assessed with use of the Disabilities of the Arm, Shoulder and Hand (DASH) as the primary outcome measure and the Oxford Shoulder Scores (OSS) and Short Form (SF-12) as secondary outcome measures at 6 weeks, 3 months, 6 months, and 1 year after treatment. Reduction was evaluated with use of radiographs. Any complications were noted at each assessment. The economic implication of each treatment was evaluated.

RESULTS

ORTSD and nonoperative groups were similar with regard to demographics at baseline. The mean degree of radiographic displacement was significantly less in patients following ORTSD fixation (1.75 mm) compared with patients who received nonoperative treatment (10.61 mm, p < 0.0001). At 1 year postoperatively, the mean DASH score was 4.67 in the nonoperative treatment group and 5.63 in the ORTSD group, and the mean OSS was 45.72 and 45.63, respectively. Patients managed with ORTSD fixation had inferior DASH scores at 6 weeks (p < 0.01). There were 5 patients who experienced failed nonoperative treatment and subsequently underwent a surgical procedure. ORTSD fixation (£3,359.73) was associated with significantly higher costs than nonoperative treatment (£796.22, p < 0.0001).

CONCLUSIONS

ORTSD fixation confers no functional benefit over nonoperative treatment at 1 year following type-III or IV disruptions of the AC joint. Although patients managed nonoperatively generally recovered faster, a substantial group of patients remained dissatisfied following nonoperative treatment and required delayed surgical reconstruction. We were unable to identify any demographic or injury-related factors that predicted a poorer outcome in these patients.

LEVEL OF EVIDENCE

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

摘要

背景

非手术治疗完全肩锁关节(AC)脱位已取得良好效果,但患者对治疗结果可能不满意。本前瞻性随机对照试验的目的是比较急性 III 或 IV 型 AC 关节脱位患者接受切开复位隧道悬吊装置(ORTSD)固定的手术治疗与非手术治疗的患者结局。

方法

60 名年龄在 16 岁至 35 岁之间的急性 III 或 IV 型 AC 关节脱位患者,根据术前影像学资料进行预评估,根据样本量计算结果,采用随机分组的方式,分别接受 ORTSD 固定或非手术治疗。采用 DASH 作为主要疗效评估指标,Oxford 肩部评分(OSS)和简短形式 36 健康调查(SF-12)作为次要疗效评估指标,分别在治疗后 6 周、3 个月、6 个月和 1 年进行评估。采用 X 线评估复位情况。每次评估时记录任何并发症。评估两种治疗方法的经济影响。

结果

ORTSD 组和非手术组患者的基线人口统计学特征相似。与非手术治疗相比,接受 ORTSD 固定的患者影像学显示的平均移位程度显著更小(1.75mm 比 10.61mm,p<0.0001)。术后 1 年,非手术治疗组的平均 DASH 评分为 4.67,ORTSD 组为 5.63,平均 OSS 分别为 45.72 和 45.63。接受 ORTSD 固定的患者在 6 周时 DASH 评分较低(p<0.01)。有 5 例患者非手术治疗失败,随后接受了手术治疗。ORTSD 固定(3359.73 英镑)的费用明显高于非手术治疗(796.22 英镑,p<0.0001)。

结论

在急性 III 或 IV 型 AC 关节脱位患者中,与非手术治疗相比,ORTSD 固定在 1 年时没有明显的功能优势。虽然接受非手术治疗的患者一般恢复较快,但仍有相当一部分患者对非手术治疗不满意,需要延迟手术重建。我们无法确定任何与患者人口统计学或损伤相关的因素,这些因素可预测患者预后较差。

证据等级

治疗水平 I。详见作者须知,了解完整的证据等级分类。

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