Objective: 

To compare unreamed intramedullary nailing versus external fixation for the treatment of Gustilo–Anderson type II and IIIA open tibial fractures admitted to a hospital in rural Uganda.

Design: 

Randomized clinical trial.

Setting: 

Regional referral hospital in Uganda.

Patients: 

Fifty-five skeletally mature patients with a Gustilo–Anderson type II or IIIA open tibia shaft fracture treated within 24 hours of injury between May 2016 and December 2019.

Intervention: 

Unreamed intramedullary nailing (n = 31) versus external fixation (n = 24).

Main Outcome Measurements: 

The primary outcome was function within 12 months of injury, measured using the Function IndeX for Trauma (FIX-IT) score. Secondary outcomes included health-related quality of life (HRQoL) using the 3-level version of the 5-dimension EuroQol instrument (EQ-5D-3L), radiographic healing using the Radiographic Union Scale for Tibia (RUST) fractures score, and clinical complications.

Results: 

Treatment with an intramedullary nail resulted in a 1.0-point higher [95% credible intervals (CrI), 0.1 to 1.9] FIX-IT score compared with external fixation. Results were similar for the secondary patient-reported outcomes, EQ-5D-3L and the visual analog scale component of the EuroQol instrument (EQ-VAS). RUST scores were not different between groups at any time point. Treatment with an intramedullary nail was associated with a 22.1% (95% CrI, −42.6% to 1.7%) lower rate of malunion and a 20.8% (95% CrI, −44.0% to 2.9%) lower rate of superficial infection.

Conclusion: 

In rural Uganda, treatment of open tibial shaft fractures with an unreamed intramedullary nail results in marginal clinically important improvements in functional outcomes, although there is likely an important reduction in malunion and superficial infection.

Level of Evidence: 

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

中文翻译：

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乌干达未扩髓髓内钉与外固定治疗开放性胫骨干骨折的随机临床试验

客观的： 

比较未扩髓髓内钉与外固定治疗乌干达农村一家医院收治的 Gustilo-Anderson II 型和 IIIA 型开放性胫骨骨折的情况。

设计： 

随机临床试验。

环境： 

乌干达地区转诊医院。

患者： 

2016 年 5 月至 2019 年 12 月期间，55 名骨骼成熟的 Gustilo-Anderson II 型或 IIIA 型开放性胫骨干骨折患者在受伤后 24 小时内接受了治疗。

干涉： 

未扩孔髓内钉 (n = 31) 与外固定器 (n = 24)。

主要结果测量： 

主要结局是受伤后 12 个月内的功能，使用创伤功能指数 (FIX-IT) 评分进行测量。次要结局包括使用 5 维 EuroQol 仪器 (EQ-5D-3L) 的 3 级版本的健康相关生活质量 (HRQoL)、使用胫骨放射学联合量表 (RUST) 骨折评分的放射学治疗以及临床并发症。

结果： 

与外固定相比，髓内钉治疗的 FIX-IT 评分高出 1.0 分 [95% 可信区间 (CrI)，0.1 至 1.9]。患者报告的次要结果 EQ-5D-3L 和 EuroQol 仪器的视觉模拟量表组件 (EQ-VAS) 的结果相似。在任何时间点，各组之间的 RUST 评分均无差异。髓内钉治疗可使畸形愈合率降低 22.1%（95% CrI，-42.6% 至 1.7%），并使浅表感染率降低 20.8%（95% CrI，-44.0% 至 2.9%）。

结论： 

在乌干达农村地区，使用未扩髓的髓内钉治疗开放性胫骨干骨折，虽然可能显着减少畸形愈合和浅表感染，但在功能结果方面取得了临床上重要的微小改善。

证据级别： 

治疗级别 II。有关证据级别的完整描述，请参阅作者须知。