手术与非手术治疗移位型关节内跟骨骨折的前瞻性随机对照多中心研究。

Operative versus nonoperative treatment of displaced intra-articular calcaneal fractures: a prospective, randomized, controlled multicenter trial.

机构信息

Department of Molecular Medicine and Surgery, Karolinska Institute, 171 77 Stockholm, Sweden.

出版信息

J Bone Joint Surg Am. 2013 Aug 7;95(15):1351-7. doi: 10.2106/JBJS.L.00759.

DOI:10.2106/JBJS.L.00759

PMID:23925738

Abstract

BACKGROUND

We conducted a prospective, randomized, controlled multicenter trial to compare operative with nonoperative treatment of displaced intra-articular calcaneal fractures.

METHODS

Eighty-two patients who presented to five trauma centers from 1994 to 1998 with an intra-articular calcaneal fracture with ≥2 mm of displacement (as verified by computed tomography) were randomized to operative or nonoperative treatment. Independent observers followed the two groups radiographically and clinically at one year and eight to twelve years. The primary outcome measures were a visual analog scale (VAS) for pain and function and the self-administrated Short Form (SF)-36 general health outcome questionnaire. The secondary outcome measures were residual pain evaluated with a VAS, the American Orthopaedic Foot & Ankle Society (AOFAS) scale, and the Olerud-Molander (OM) scale.

RESULTS

Forty-two patients in the operative treatment group and forty in the nonoperative group were included. The two groups were comparable with respect to age, sex, and fracture types. Seventy-six patients were available for follow-up at one year and fifty-eight at eight to twelve years. The primary and secondary outcome measures did not differ significantly between the two treatment groups at one year of follow-up. At eight to twelve years of follow-up, there was a trend toward better scores on the patient-reported primary VAS score for pain and function (p = 0.07) and the physical component of the SF-36 (p = 0.06) in the operative group. The prevalence of radiographically evident posttraumatic subtalar arthritis was lower in the operative group (risk reduction, 41%).

CONCLUSIONS

Operative treatment was not superior in managing displaced intra-articular calcaneal fractures at one year of follow-up but appeared to have some benefits at eight to twelve years. Operative treatment was associated with a higher risk of complications but a reduced prevalence of posttraumatic arthritis evident on follow-up radiographs.

LEVEL OF EVIDENCE

Therapeutic level II. See instructions for authors for a complete description of levels of evidence.

摘要

背景

我们进行了一项前瞻性、随机、对照的多中心试验，比较手术与非手术治疗移位性关节内跟骨骨折的疗效。

方法

1994 年至 1998 年，共有 82 名患者在 5 个创伤中心就诊，他们患有关节内跟骨骨折，且存在≥2 毫米的移位（通过计算机断层扫描证实），将其随机分为手术治疗或非手术治疗组。独立观察者在一年和 8 至 12 年时对两组患者进行影像学和临床随访。主要结局指标为疼痛和功能视觉模拟量表（VAS）评分和自我管理的 Short Form（SF）-36 一般健康问卷。次要结局指标为残余疼痛的 VAS 评分、美国矫形足踝协会（AOFAS）评分和 Olerud-Molander（OM）评分。

结果

手术治疗组 42 例，非手术治疗组 40 例。两组患者的年龄、性别和骨折类型具有可比性。76 例患者在一年时可进行随访，58 例在 8 至 12 年时可进行随访。两组患者在一年时的主要和次要结局指标无显著差异。在 8 至 12 年的随访中，手术组患者报告的主要 VAS 疼痛和功能评分（p = 0.07）和 SF-36 物理成分评分（p = 0.06）有改善的趋势。在影像学上，术后创伤后距下关节炎的发生率在手术组较低（风险降低 41%）。