Evaluation of the Efficacy and Safety of FFX Facet Cages Compared With 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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引用次数: 0
Abstract
Study design: Hybrid retrospective/prospective study.
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).
Summary of background data: A previous single-arm study reported on the safety, fusion rate, and patient outcomes associated with the use of the FFX facet cage in patients with lumbar spinal stenosis. There are no long-term studies reporting outcomes with this device compared with the use of pedicle screw fixation.
Methods: Following a medical records review, subjects meeting the inclusion and exclusion criteria were consented to 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. Preoperative 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 2 groups for the primary composite fusion endpoint assessed with the FFX group achieving a 91% bony facet fusion rate. 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 with the FFX group (3.6%). Although both groups experienced significant improvements in VAS and ODI scores versus preoperative assessment, there was no difference between the 2 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 with PS fixation.
期刊介绍：
Clinical Spine Surgery is the ideal journal for the busy practicing spine surgeon or trainee, as it is the only journal necessary to keep up to date with new clinical research and surgical techniques. Readers get to watch leaders in the field debate controversial topics in a new controversies section, and gain access to evidence-based reviews of important pathologies in the systematic reviews section. The journal features a surgical technique complete with a video, and a tips and tricks section that allows surgeons to review the important steps prior to a complex procedure.
Clinical Spine Surgery provides readers with primary research studies, specifically level 1, 2 and 3 studies, ensuring that articles that may actually change a surgeon’s practice will be read and published. Each issue includes a brief article that will help a surgeon better understand the business of healthcare, as well as an article that will help a surgeon understand how to interpret increasingly complex research methodology. Clinical Spine Surgery is your single source for up-to-date, evidence-based recommendations for spine care.
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