Raji Oluwatodimu Richard, Tandio Joshua H, Mayer Sarah, Escobar Alexander, Himmelwright Brett A, Beall Douglas P, Caraway David L, Leasure Jeremi M
Medical Device Development, San Francisco, CA, USA.
Department of Orthopedics, UCSF Health St. Mary's Hospital, San Francisco, CA, USA.
Med Devices (Auckl). 2024 Oct 25;17:385-399. doi: 10.2147/MDER.S474734. eCollection 2024.
To concurrently assess and compare the fixation efficacy, invasiveness, and fusion potential of a posterior integrated transfixation cage system to the posterolateral threaded implant and lateral triangular rod systems, in a cadaveric model.
Twelve (12) cadaveric sacroiliac joint specimens were utilized and tested within the single-leg stance multidirectional pure moment bending model. Each specimen was tested in the intact, destabilized, treated (using posterior, posterolateral, and lateral systems), and post-fatigue conditions by applying 0 to ± 7.5 Nm of moment in flexion-extension, axial rotation, and lateral bending while measuring the angular range of motion between the sacrum and ilium. Computational models were reconstructed from Computed Tomography (CT) scans and manufacturer surgical technique guides. The models were utilized to quantify the volume of bone removed during implantation and the surface area available for fusion.
The posterior integrated transfixation cage system and the lateral triangular rods produced equivalent motion reduction in all motion planes ( > 0.583). The posterolateral cylindrical threaded implant produced less motion reductions than the posterior and lateral implants in flexion-extension (6% ± 3% vs 37% ± 10% and 33% ± 11%, respectively, <0.05). The posterior system removed 22%-60% less bone volume from the sacrum and ilium (P<0.10), introduced 200%-270% more implant surface to the joint space (P<0.01) and decorticated 75%-375% more joint surface area (<0.01).
The posterior integrated transfixation single-implant cage system is superior to the posterolateral cylindrical threaded single-implant system. Its performance in osteopenic bone is equivalent to the lateral triangular rod system in healthy bone; however, the posterior integrated transfixation cage system requires a single implant, while the lateral triangular rod system requires three. The posterior implant removes the least bone volume and has the most surface area for fusion, providing a significantly better opportunity for robust sacroiliac joint arthrodesis.
在尸体模型中，同时评估和比较后整合经固定融合器系统与后外侧螺纹植入物及外侧三角棒系统的固定效果、侵入性和融合潜力。
使用12个尸体骶髂关节标本，并在单腿站立多方向纯力矩弯曲模型中进行测试。每个标本在完整、不稳定、治疗（使用后方、后外侧和外侧系统）以及疲劳后条件下进行测试，在屈伸、轴向旋转和侧方弯曲时施加0至±7.5 Nm的力矩，同时测量骶骨和髂骨之间的角度运动范围。根据计算机断层扫描（CT）扫描和制造商手术技术指南重建计算模型。这些模型用于量化植入过程中去除的骨体积以及可用于融合的表面积。
后整合经固定融合器系统和外侧三角棒在所有运动平面上产生了相当的运动减少（>0.583）。后外侧圆柱形螺纹植入物在屈伸时产生的运动减少比后方和外侧植入物少（分别为6%±3%对37%±10%和33%±11%，P<0.05）。后方系统从骶骨和髂骨去除的骨体积减少22%-60%（P<0.10），向关节间隙引入的植入物表面积增加200%-270%（P<0.01），并且去皮质的关节表面积增加75%-375%（P<0.01）。
后整合经固定单植入物融合器系统优于后外侧圆柱形螺纹单植入物系统。其在骨质减少骨中的性能与健康骨中的外侧三角棒系统相当；然而，后整合经固定融合器系统需要单个植入物，而外侧三角棒系统需要三个。后方植入物去除的骨体积最少，具有最大的融合表面积，为骶髂关节坚固融合提供了明显更好的机会。
