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一种用于旋转引导生长的新型钢板设计:在未成熟猪股骨上的实验研究

A novel plate design for rotational guided growth: An experimental study in immature porcine femurs.

作者信息

Halloum Ahmed, Rahbek Ole, Gholinezhad Shima, Kold Søren, Rasmussen John, Rölfing Jan Duedal, Tirta Maria, Arildsen Marie, Abood Ahmed A

机构信息

Interdisciplinary Orthopaedics, Aalborg University Hospital, Aalborg, Denmark.

Department of Materials and Production, Aalborg University, Aalborg, Denmark.

出版信息

J Orthop Res. 2025 Mar;43(3):617-621. doi: 10.1002/jor.26019. Epub 2024 Nov 21.

Abstract

Guided growth for correction of rotational deformities has been reported in several preclinical and clinical studies. Different adverse effects, like growth retardation, articular deformities, and rebound effect have been reported. We have tested a novel plate concept (RotOs Plate) intended for the correction of rotational deformities of long bones by guided growth in a porcine model. The plate has sliding screw holes intended to allow for longitudinal growth. Fourteen skeletally immature female pigs were included in the study in a paired design. Mean duration of intervention was 88 days (83-98). CTscans and X-rays were performed at plate insertion and removal. From the CTscans, 3D-models of the left and right femora were made and used for measuring the achieved rotation. Three pigs were excluded for reasons not related to the plate design. The plates rotated as intended in all pigs. In two pigs, there was a cut-out of the proximal screw on the lateral side. Data from these two pigs were included in the results. We observed a mean difference in rotation between the left and right femur of 5.7° in the external direction (CI: 3.7°-7.7°). No statistically significant deformities in the coronal and sagittal plane were observed. The plate worked as intended, that is, the intended rotation was achieved. CLINICAL SIGNIFICANCE: This large animal study shows promising results for the feasibility of the method. It is an important first step in validating the technique and detecting possible adverse effects before clinical studies.

摘要

在多项临床前和临床研究中,已有关于引导生长矫正旋转畸形的报道。也有报道称存在不同的不良反应,如生长迟缓、关节畸形和反弹效应。我们在猪模型中测试了一种用于通过引导生长矫正长骨旋转畸形的新型钢板概念(RotOs钢板)。该钢板有滑动螺孔,旨在允许纵向生长。本研究采用配对设计纳入了14只骨骼未成熟的雌性猪。平均干预持续时间为88天(83 - 98天)。在钢板植入和取出时进行CT扫描和X线检查。根据CT扫描结果,制作左右股骨的三维模型,并用于测量实现的旋转角度。3只猪因与钢板设计无关的原因被排除。所有猪的钢板均按预期旋转。有2只猪的外侧近端螺钉出现穿出。这两只猪的数据被纳入结果。我们观察到左右股骨在向外方向上的平均旋转差异为5.7°(置信区间:3.7° - 7.7°)。在冠状面和矢状面未观察到统计学上显著的畸形。钢板按预期发挥作用,即实现了预期的旋转。临床意义:这项大型动物研究表明该方法的可行性有令人鼓舞的结果。这是在临床研究之前验证该技术并检测可能的不良反应的重要第一步。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7326/11806649/99606d518503/JOR-43-617-g006.jpg

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