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多中心、前瞻性、观察性研究:非手术与手术治疗高能型锁骨中段骨折的疗效比较。

Multicenter, Prospective, Observational Study of Nonoperative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures.

机构信息

Department of Orthopedic Surgery, Prisma Health, Greenville, SC.

Spartanburg Regional Health System, Spartanburg, SC; and.

出版信息

J Orthop Trauma. 2024 Jul 1;38(7):345-350. doi: 10.1097/BOT.0000000000002817.

DOI:10.1097/BOT.0000000000002817
PMID:38837208
Abstract

OBJECTIVES

Evaluate if nonoperative or operative treatment of displaced clavicle fractures delivers reduced rates of nonunion and improved Disability of the Arm, Shoulder, and Hand (DASH) scores.

DESIGN

Multicenter, prospective, observational.

SETTING

Seven Level 1 Trauma Centers in the United States.

PATIENT SELECTION CRITERIA

Adults with closed, displaced (100% displacement/shortened >1.5 cm) midshaft clavicle fractures (Orthopaedic Trauma Association 15.2) were treated nonoperatively, with plates and screw fixation, or with intramedullary fixation from 2003 to 2018.

OUTCOME MEASURES AND COMPARISONS

DASH scores (2, 6 weeks, 3, 6, 12, and 24 months), reoperation, and nonunion were compared between the nonoperative, plate fixation, and intramedullary fixation groups.

RESULTS

Four hundred twelve patients were enrolled, with 203 undergoing plate fixation, 26 receiving intramedullary fixation, and 183 treated nonoperatively. The average age of the nonoperative group was 40.1 (range 18-79) years versus 35.8 (range 18-74) in the plate group and 39.3 (range 19-56) in the intramedullary fixation group (P = 0.06). One hundred forty (76.5%) patients in the nonoperative group were male compared with 154 (75.9%) in the plate group and 18 (69.2%) in the intramedullary fixation group (P = 0.69). All groups showed similar DASH scores at 2 weeks, 12 months, and 24 months (P > 0.05). Plate fixation demonstrated better DASH scores (median = 20.8) than nonoperative (median = 28.3) at 6 weeks (P = 0.04). Intramedullary fixation had poorer DASH scores at 6 weeks, 3 months, and 6 months than plate fixation and worse DASH scores than nonoperative at 6 months (P < 0.05). The nonunion rate for nonoperative treatment (14.6%) was significantly higher than the plate group (0%) (P < 0.001).

CONCLUSIONS

Operative treatment of displaced clavicle fractures provided lower rates of nonunion than nonoperative treatment. Except at 6 weeks, no difference was observed in DASH scores between plate fixation and nonoperative treatment. Intramedullary fixation resulted in worse DASH scores than plate fixation at 6 weeks, 3 months, and 6 months and worse DASH scores than nonoperative at 6 months. Implant removal was the leading reason for reoperation in the plate and intramedullary fixation groups, whereas surgery for nonunion was the primary reason for surgery in the nonoperative group.

LEVEL OF EVIDENCE

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

摘要

目的

评估移位锁骨骨折的非手术治疗或手术治疗是否能降低不愈合率并改善手臂、肩部和手部残疾(DASH)评分。

设计

多中心、前瞻性、观察性研究。

地点

美国 7 家 1 级创伤中心。

患者选择标准

2003 年至 2018 年间,接受过闭合性、移位(100%移位/缩短>1.5cm)锁骨中段骨折(骨科创伤协会 15.2)治疗的成年人,采用非手术、钢板螺钉固定或髓内固定。

结果测量和比较

DASH 评分(2、6 周、3、6、12 和 24 个月)、再次手术和不愈合情况在非手术组、钢板固定组和髓内固定组之间进行了比较。

结果

共纳入 412 例患者,其中 203 例行钢板固定,26 例行髓内固定,183 例行非手术治疗。非手术组的平均年龄为 40.1(18-79 岁),钢板组为 35.8(18-74 岁),髓内固定组为 39.3(19-56 岁)(P=0.06)。非手术组中 140(76.5%)例为男性,钢板组为 154(75.9%)例,髓内固定组为 18(69.2%)例(P=0.69)。所有组在 2 周、12 个月和 24 个月时的 DASH 评分均相似(P>0.05)。钢板固定在 6 周时(P=0.04)的 DASH 评分(中位数=20.8)优于非手术治疗(中位数=28.3)。髓内固定在 6 周、3 个月和 6 个月时的 DASH 评分均低于钢板固定,在 6 个月时的 DASH 评分也低于非手术治疗(P<0.05)。非手术治疗的不愈合率(14.6%)明显高于钢板组(0%)(P<0.001)。

结论

手术治疗移位锁骨骨折的不愈合率低于非手术治疗。除了 6 周外,钢板固定和非手术治疗在 DASH 评分方面没有差异。髓内固定在 6 周、3 个月和 6 个月时的 DASH 评分均差于钢板固定,在 6 个月时的 DASH 评分也差于非手术治疗。钢板和髓内固定组的主要再手术原因是植入物取出,而非手术组的主要手术原因是治疗不愈合。

证据水平

治疗性 2 级。有关证据水平的完整描述,请参见作者说明。

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