骨折表与侧位治疗股骨骨折顺行髓内固定(FLiP研究):一项多中心集群随机交叉先导研究的临床结果

IF 1.8 3区 医学 Q3 ORTHOPEDICS
Daniel E Axelrod, Sheila Sprague, Ernesto Guerra-Farfan, Yaiza Garcia-Sanchez, Brad Meulenkamp, Melanie Dodd-Moher, Sofia Bzovsky, Christy Shibu, Gina Del Fabbro, Jodi L Gallant, Thomas Mammen, Herman Johal
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引用次数: 0

摘要

目的:确定患者在骨折床(SFT)上仰卧位或在放射光床(LRT)上侧卧位是否能降低行顺行髓内固定治疗股骨干骨折患者临床上重要的股骨旋转不良风险。设计:一项多中心、前瞻性群随机交叉试验。地点:三个骨科创伤中心。患者选择标准:18岁以上股骨骨干骨折患者(AO/OTA 32-A、32-B或32-C),适合行顺行髓内固定。结果测量和比较:主要临床结果是通过双侧术后计算机断层扫描(CT)测量手术肢体的旋转对齐,以未受伤的肢体为参照。次要临床结果包括生活质量、活动能力、手术时间、透视使用、切开复位需要、复位辅助工具的使用、相关定位并发症、住院时间和呼吸机支持天数。结果:共有101例患者入组,其中54例随机分为SFT组,47例随机分为LRT组。SFT组26例(48.1%),LRT组27例(57.4%)。SFT组平均年龄为60.2岁(SD 25.8岁),LRT组平均年龄为62.7岁(SD 27.6岁)。骨折多为跌倒(59.3% SFT, 66% LRT)、转子下骨折(63% SRT, 61.7% LRT)、单纯AO/OTA 32-A骨折(53.7% SRT, 53.2% LRT)。在20名(37.7%)SFT和9名(19.1%)LRT参与者中,发生股骨旋转不良≤15°的几率是SFT组的2.6倍(95%可信区间为1.0 ~ 6.4;p=0.04)。两组患者与正常解剖相比,更容易出现外旋畸形,外旋在SFT中更为常见(69.8%对59.6%,p=0.17)。次要结局无统计学意义(P < 0.05)。结论:在这项可行性试验的临床结果评估中,接受SFT治疗的患者比接受LRT治疗的患者更容易在股骨干骨折固定后发生股骨旋转不良。证据等级:二级。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Fracture Table vs. Lateral Positioning for Antegrade Intramedullary Fixation of Femur Fractures (The FLiP Study): The Clinical Outcomes of a Multi-Centre Cluster Randomized Crossover Pilot Study.

Objectives: To determine whether patient positioning supine on a fracture table (SFT) or laterally on a radiolucent table (LRT) reduced the risk of clinically important femoral malrotation in patients undergoing antegrade intramedullary fixation for femoral shaft fractures.

Design: A pilot multicentre, prospective cluster randomized crossover trial.

Setting: Three orthopaedic trauma centres.

Patient selection criteria: Patients over 18 years of age with femoral shaft fractures (AO/OTA 32-A, 32-B, or 32-C) appropriate for antegrade intramedullary fixation.Outcome Measures and Comparison: The primary clinical outcome was rotational alignment of the operative limb measured through a bilateral postoperative computed tomography (CT) scan, using the uninjured limb as a reference. Secondary clinical outcomes included quality of life, mobility, operative time, fluoroscopy use, need for open reduction, use of reduction adjuncts, associated positioning complications, hospital stay, and ventilator support days.

Results: A total of 101 patients were enrolled, with 54 randomized to SFT and 47 randomized to LRT. There were 26 females (48.1%) in the SFT group and 27 females (57.4%) in the LRT group. The mean age was 60.2 years (SD 25.8 years) in the SFT group and 62.7 years (SD 27.6 years) in LRT group. Most fractures resulted from falls (59.3% SFT; 66% LRT), were subtrochanteric (63% SRT; 61.7% LRT), and classified as simple AO/OTA 32-A (53.7% SRT; 53.2% LRT). Femoral malrotation >15° occurred in 20 (37.7%) SFT and 9 (19.1%) LRT participants The odds of femoral malrotation of ≥15° were 2.6 times higher in the SFT group (95% Confidence Interval 1.0 to 6.4; p=0.04). In both groups, patients were more likely to have an external rotation deformity compared to their native anatomy, with external rotation more common in SFT (69.8% versus 59.6%; p=0.17). No secondary outcomes reached statistical significance (P>0.05).

Conclusions: In this clinical outcome assessment of patients enrolled in a feasibility trial, patients treated with SFT were more likely to have femoral malrotation after femoral shaft fracture fixation than patients treated with LRT.

Level of evidence: Level 2.

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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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