Infrapatellar vs suprapatellar nailing for fractures of the tibia (INSURT study): A multicentered randomized controlled trial.

IF 1.6 3区 医学 Q3 ORTHOPEDICS
David J Cinats, Darius Viskontas, Trevor Stone, Bertrand Perey, Farhad Moola, Dory Boyer, H Michael Lemke, Kelly Apostle, Alan J Johnstone
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引用次数: 0

Abstract

Objectives: To compare suprapatellar and infrapatellar tibial nail insertion approaches on post-operative knee pain.

Methods: Design: Randomized controlled trial.

Setting: Multi-centered academic level 1 trauma centers.

Patient selection criteria: Included were all patients 18 to 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 (AKT) and Aberdeen Standing Test (AST) (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, one year, and two years post-operatively.

Results: 254 patients were randomized with 128 patients randomized to suprapatellar nailing and 117 patients randomized to infrapatellar nailing. 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 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 one year (1.4 vs 2.7 p=0.0021) post-operatively and was statistical significant but not clinically significant. The AKT demonstrated that patients who underwent suprapatellar nailing could bear significantly more weight through their operative knee compared to 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), one year (49% vs 45% p=0.0007), and two years (50% vs 46% p=0.001) post-operatively.

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

Level of evidence: Level I.

髌下与髌上钉治疗胫骨骨折(INSURT研究):一项多中心随机对照试验。
目的:比较髌上胫钉入路与髌下胫钉入路治疗术后膝关节疼痛的疗效。方法:设计:随机对照试验。环境:多中心学术一级创伤中心。患者选择标准:纳入所有年龄在18 - 65岁之间的OTA/AO 42型和43A型骨折患者,这些患者可适应并适用扩孔髓内钉修复。结果测量和比较:患者随机通过髌上入路或髌下入路接受胫骨髓内钉。主要观察指标为跪地60秒后膝关节疼痛的视觉模拟评分(VAS)。该研究被设计为有80%的能力检测到VAS对跪处疼痛的1.6分差异,这被认为具有临床意义。次要结果包括阿伯丁跪地测试(AKT)和阿伯丁站立测试(AST)(客观测量跪地和站立时的负重能力)、Lysholm评分、EQ-5D评分和工作效率和活动障碍问卷(WPAI)。分别于术后6周、4个月、6个月、1年和2年记录结果。结果:254例患者随机分组,其中髌骨上钉组128例,髌骨下钉组117例。髌上组96例(男性68.8%)平均年龄42.4岁,范围18 ~ 60岁;髌下组93例(男性69.2%)平均年龄38.8岁,范围19 ~ 52岁,完成2年随访。髌上组膝跪60秒后VAS在术后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)、1年(1.4 vs 2.7 p=0.0021)均低于髌下组,差异均有统计学意义,但无临床意义。AKT表明,术后6周(36%对27% p=0.0004)、4个月(45%对41% p=0.0012)、6个月(47%对43% p=0.001)、1年(49%对45% p=0.0007)和2年(50%对46% p=0.001),接受髌上钉治疗的患者通过手术膝关节承受的重量明显高于髌下治疗组。结论:髌上钉与髌下钉在VAS膝关节疼痛或PROMs方面无明显临床差异。髌上组患者术后2年内可通过手术膝关节承受更多重量。在考虑钉入技术时,应告知患者下跪的能力和钉入方法。证据等级:一级。
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来源期刊
Journal of Orthopaedic Trauma
Journal of Orthopaedic Trauma 医学-运动科学
CiteScore
3.90
自引率
8.70%
发文量
396
审稿时长
3-8 weeks
期刊介绍: Journal of Orthopaedic Trauma is devoted exclusively to the diagnosis and management of hard and soft tissue trauma, including injuries to bone, muscle, ligament, and tendons, as well as spinal cord injuries. Under the guidance of a distinguished international board of editors, the journal provides the most current information on diagnostic techniques, new and improved surgical instruments and procedures, surgical implants and prosthetic devices, bioplastics and biometals; and physical therapy and rehabilitation.
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