Evaluation of the Efficacy and Safety of FFX Facet Cages Compared to Pedicle Screw Fixation in Patients with Lumbar Spinal Stenosis: A Long-Term Study

Omar Houari, Arnaud Douanla, Mehdi Ben Ammar, Mustapha Benmekhbi, Jihad Mortada, Gabriel Lungu, Cristian Magheru, Jimmy Voirin, Pablo Ariel Lebedinsky, Mariano Musacchio, Federico Bolognini, Robin Srour
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Abstract

Objective: The study evaluated the long-term safety and efficacy of the FFX facet cage versus pedicle screw (PS) fixation in patients with lumbar spinal stenosis (LSS). Methods: A hybrid retrospective/prospective study design was used. Following a medical records review, subjects meeting the inclusion/exclusion criteria were consented and enrolled in the prospective arm of the study. CT-scans and dynamic X-rays were performed to assess fusion rates, range of motion and translation. Adverse events during the 2-year post-index procedure were also analyzed. Pre-operative and 2+ year Visual Analogue Scale (VAS) back and leg scores and Oswestry Disability Index (ODI) were also obtained. Results: A total of 112 subjects were enrolled with 56 patients included in the PS and FFX groups. Mean age was 63.1±11.2 and 67.1±10.9 years and the mean number of levels operated was 1.8±0.8 and 2.3±1.0 respectively for the PS and FFX groups. There was no difference between the two groups for the primary composite fusion endpoint assessed (respectively 60.0% vs. 70.9%, p=0.120). There was also no difference in postoperative complications or adverse events during the 2-year follow-up period. A higher percentage of patients in the PS group (10.7%) required reoperation compared to the FFX group (3.6%). While both groups experienced significant improvements in VAS and ODI scores versus pre-operative assessment, there was no difference between the two groups. Conclusion: The present study documents the long-term safety and efficacy of the FFX device in patients with LSS with a reduction in reoperation rate when compared to PS fixation.
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评估腰椎管狭窄症患者使用 FFX 椎板面固定架与椎弓根螺钉固定的有效性和安全性:一项长期研究
研究目的该研究评估了腰椎管狭窄症(LSS)患者使用 FFX 椎面骨架与椎弓根螺钉(PS)固定的长期安全性和有效性:方法:采用回顾性/前瞻性混合研究设计。经过病历审查,符合纳入/排除标准的受试者被同意并纳入前瞻性研究部分。研究人员通过 CT 扫描和动态 X 光片评估融合率、活动范围和平移。此外,还对指标术后两年内的不良事件进行了分析。此外,还获得了术前和术后两年多的视觉模拟量表(VAS)背部和腿部评分以及奥斯韦特里残疾指数(ODI)。结果:共有 112 名受试者参加,其中 PS 组和 FFX 组共有 56 名患者。PS 组和 FFX 组的平均年龄分别为(63.1±11.2)岁和(67.1±10.9)岁,平均手术层数分别为(1.8±0.8)层和(2.3±1.0)层。两组的主要复合融合终点评估结果无差异(分别为60.0% vs. 70.9%,P=0.120)。在两年的随访期间,术后并发症或不良事件也没有差异。PS 组需要再次手术的患者比例(10.7%)高于 FFX 组(3.6%)。与术前评估相比,两组患者的 VAS 和 ODI 评分均有明显改善,但两组之间并无差异。结论:本研究证实了 FFX 装置在 LSS 患者中的长期安全性和有效性,与 PS 固定相比,FFX 装置降低了再手术率。
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