钢板固定与非手术治疗移位型锁骨中段骨折的随机临床试验。

Plate fixation compared with nonoperative treatment of displaced midshaft clavicular fractures: a randomized clinical trial.

机构信息

Department of Orthopedics, Alborg University Hospital, Farsø, Denmark.

Department of Orthopedics, Viborg Regional Hospital, Viborg, Denmark.

出版信息

Bone Joint J. 2018 Oct;100-B(10):1385-1391. doi: 10.1302/0301-620X.100B10.BJJ-2017-1137.R3.

DOI:10.1302/0301-620X.100B10.BJJ-2017-1137.R3

PMID:30295536

Abstract

AIMS

Recent studies of nonoperatively treated displaced midshaft clavicular fractures have shown a high incidence of nonunion and unsatisfactory functional outcome. Some studies have shown superior functional results and higher rates of healing following operative treatment. The aim of this study was to compare the outcome in these patients after nonoperative management with those treated with fixation.

PATIENTS AND METHODS

In a multicentre, parallel randomized controlled trial, 146 adult patients with an acute displaced fracture of the midthird of the clavicle were randomized to either nonoperative treatment with a sling (71, 55 men and 16 women with a mean age of 39 years, 18 to 60) or fixation with a pre-contoured plate and locking screws (75, 64 men and 11 women with a mean age of 40 years, 18 to 60). Outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) Score, the Constant Score, and radiographical evidence of union. Patients were followed for one year.

RESULTS

A total of 60 patients in the nonoperative group and 64 in the operative group completed one-year follow-up. At three months' follow-up, both the median DASH (1.7 vs 8.3) and median Constant scores (97 vs 90) were significantly better in the operated group (both p = 0.02). After six months and one year, there was no difference in the median DASH or Constant scores. The rate of nonunion was lower in the operative group (2 vs 11 patients, p < 0.02). Nine patients in the nonoperative group underwent surgery for nonunion. The plate was subsequently removed in 16 patients (25%). One patient had a new fracture after removal of the plate and one underwent revision surgery for failure of fixation.

CONCLUSION

Fixation of a displaced midshaft clavicular fracture using a pre-contoured plate and locking screws results in faster functional recovery and a higher rate of union compared with nonoperative management, but the function of the shoulder is equal after six months and at one year. Cite this article: Bone Joint J 2018;100-B:1385-91.

摘要

目的

最近对未经手术治疗的移位锁骨中段骨折的研究表明，不愈合和功能结果不满意的发生率较高。一些研究表明，手术治疗后的功能结果更好，愈合率更高。本研究的目的是比较这些患者经非手术治疗与固定治疗后的结果。

患者和方法

在一项多中心、平行随机对照试验中，146 例成人急性移位性锁骨中段骨折患者被随机分为非手术治疗（吊带，71 例，55 例男性和 16 例女性，平均年龄 39 岁，18 至 60 岁）或固定治疗（预成型钢板和锁定螺钉，75 例，64 例男性和 11 例女性，平均年龄 40 岁，18 至 60 岁）。使用手臂、肩部和手残疾（DASH）评分、常数评分和影像学愈合证据评估结果。患者随访 1 年。

结果

非手术组共 60 例患者和手术组 64 例患者完成 1 年随访。在 3 个月随访时，手术组的 DASH 中位数（1.7 比 8.3）和常数评分中位数（97 比 90）均显著更好（均 p = 0.02）。6 个月和 1 年后，DASH 和常数评分的中位数无差异。手术组的不愈合率较低（2 例比 11 例，p < 0.02）。非手术组中有 9 例患者因不愈合而行手术治疗。随后有 16 例（25%）患者取出钢板，其中 1 例在取出钢板后发生新骨折，1 例因固定失败而行翻修手术。