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胫骨骨折的髌下与髌上髓内钉固定术(INSURT研究):一项多中心随机对照试验

Infrapatellar Versus Suprapatellar Nailing for Fractures of the Tibia (INSURT Study): A Multicentered Randomized Controlled Trial.

作者信息

Cinats David J, Viskontas Darius, Stone Trevor, Perey Bertrand, Moola Farhad, Boyer Dory, Lemke H Michael, Apostle Kelly, Johnstone Alan J

机构信息

Department of Orthopaedics, Royal Columbian Hospital, University of British Columbia, Canada ; and.

Aberdeen Royal Infirmary, Foresterhill, Aberdeen, United Kingdom .

出版信息

J Orthop Trauma. 2025 Oct 1;39(10):537-541. doi: 10.1097/BOT.0000000000003029.

DOI:10.1097/BOT.0000000000003029
PMID:40504644
Abstract

OBJECTIVES

To compare suprapatellar and infrapatellar tibial nail insertion approaches on postoperative knee pain.

DESIGN

Randomized controlled trial.

SETTING

Multicentered academic level 1 trauma centers.

PATIENT SELECTION CRITERIA

Included were all patients 18-65 years of age with nailing OTA/AO type 42 and 43A fractures amenable to and indicated for repair with reamed intramedullary nailing.

OUTCOME MEASURES AND COMPARISONS

Patients were randomized to receive a tibial intramedullary nail through either a suprapatellar or infrapatellar approach. The primary outcome was the visual analog scale (VAS) for knee pain after kneeling for 60 seconds. The study was designed to have 80% power to detect a 1.6-point difference in the VAS for pain on kneeling, which was considered clinically significant. Secondary outcomes included the Aberdeen Kneeling Test and Aberdeen Standing Test (objective measures of weight-bearing capacity while kneeling and standing), Lysholm score, EQ-5D score, and Work Productivity and Activity Impairment Questionnaire (WPAI). The outcomes were recorded at 6 weeks, 4 months, 6 months, 1 year, and 2 years postoperatively.

RESULTS

In total, 254 patients were randomized with 128 patients randomized to suprapatellar nailing and 117 patients randomized to infrapatellar nailing. In total, 96 patients (68.8% male) in the suprapatellar group (mean age 42.4 years, range 18-60 years) and 93 patients (69.2% male) in the infrapatellar group (mean age 38.8 years, range 19-52 years) completed 2-year follow-up. The VAS after kneeling for 60 seconds in the suprapatellar group was lower than that in the infrapatellar group at 6 weeks (4.1 vs. 5.2 P = 0.012), 4 months (2.8 vs. 4.1 P = 0.0003), 6 months (2.2 vs. 3.2 P = 0.0041), and 1 year (1.4 vs. 2.7 P = 0.0021) postoperatively and was statistically significant but not clinically significant. The Aberdeen Kneeling Test demonstrated that patients who underwent suprapatellar nailing could bear significantly more weight through their operative knee compared with the infrapatellar treatment group at 6 weeks (36% vs. 27% P = 0.0004), 4 months (45% vs. 41% P = 0.0012), 6 months (47% vs. 43% P = 0.001), 1 year (49% vs. 45% P = 0.0007), and 2 years (50% vs. 46% P = 0.001) postoperatively.

CONCLUSIONS

There was no clinically significant difference between suprapatellar and infrapatellar nailing in terms of VAS knee pain or patient-reported outcome measures. Patients in the suprapatellar cohort could bear more weight through their operative knee up to and including 2 years postsurgery. Patients should be counseled on the ability to kneel and the nail insertion method when considering nail insertion technique.

LEVEL OF EVIDENCE

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

摘要

目的

比较髌上和髌下胫骨钉插入方法对术后膝关节疼痛的影响。

设计

随机对照试验。

地点

多中心一级学术创伤中心。

患者选择标准

纳入所有年龄在18 - 65岁,因OTA/AO 42型和43A骨折适合并需行扩髓髓内钉修复的患者。

观察指标及比较

患者随机接受通过髌上或髌下途径插入胫骨髓内钉。主要观察指标为跪60秒后膝关节疼痛的视觉模拟量表(VAS)。该研究旨在有80%的把握度检测出跪姿疼痛VAS有1.6分的差异,这被认为具有临床意义。次要观察指标包括阿伯丁跪姿试验和阿伯丁站立试验(跪姿和站立时负重能力的客观测量)、Lysholm评分、EQ - 5D评分以及工作效率和活动障碍问卷(WPAI)。这些指标在术后6周、4个月、6个月、1年和2年记录。

结果

总共254例患者被随机分组,128例患者被随机分配接受髌上钉固定,117例患者被随机分配接受髌下钉固定。髌上组共有96例患者(68.8%为男性,平均年龄42.4岁,范围18 - 60岁),髌下组共有93例患者(69.2%为男性,平均年龄38.8岁,范围19 - 52岁)完成了2年随访。术后6周(4.1 vs. 5.2,P = 0.012)、4个月(2.8 vs. 4.1,P = 0.0003)、6个月(2.2 vs. 3.2,P = 0.0041)和1年(1.4 vs. 2.7,P = 0.0021)时,髌上组跪60秒后的VAS低于髌下组,差异有统计学意义,但无临床意义。阿伯丁跪姿试验表明,与髌下治疗组相比,接受髌上钉固定的患者在术后6周(36% vs. 27%,P = 0.0004)、4个月(45% vs. 41%,P = 0.0012)、6个月(47% vs. 43%,P = 0.001)、1年(49% vs. 45%,P = 0.0007)和2年(50% vs. 46%,P = 0.001)时,通过手术侧膝关节能承受显著更多的重量。

结论

在VAS膝关节疼痛或患者报告的结局指标方面,髌上和髌下钉固定之间无临床显著差异。髌上组患者在术后直至2年通过手术侧膝关节能承受更多重量。在考虑钉插入技术时,应向患者告知跪姿能力和钉插入方法。

证据级别

治疗性I级。有关证据级别的完整描述,请参阅作者指南。

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