Facet Arthrodesis with the FFX Device: One-Year Results from a Prospective Multicenter Study

Srour, Robin; Gdoura, Yassine; Delaitre, Mariette; Mortada, Jihad; Benali, Mustapha Ali; Millot, Fabrice; Hritcu, Daniel; Timofeev, Alexandre; Sellal, François

doi:10.14444/7149

Cited by 6 publications

(10 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The findings of the present study indicate that in case of LSS, the FFX device has less impact on the biomechanics of the spine compared with PS and an improved stability compared with LAM alone, thus potentially preventing the risk of postsurgical spondylolisthesis by promoting fusion. 8 Our results suggest the use of the FFX device also has a reduced risk of impacting adjacent anatomical structures compared with PS as a result of a reduced amount of projected stress on the facets and adjacent level discs during the prefusion period, while having equivalent mechanical stability following fusion. Appropriately designed clinical studies are needed to confirm the above.…”

Section: Discussionmentioning

confidence: 66%

“…The use of the FFX device in conjunction with laminectomy offers a technique which can improve postsurgical spinal stability by promoting a high rate of fusion, 8 and based on the results of the present study, may provide benefit of decreased rigidity compared with PS constructs prior to achieving fusion. This combined with the less invasive surgical approach for placing the FFX devices compared with PS and the associated potential for a reduction in operative time and blood loss, also support the clinical utility of the device for LSS.…”

Section: Discussionmentioning

confidence: 75%

“…Bone graft material is placed inside and posterior to the device to facilitate fusion over time. 8 The biomechanics of different spinal constructs has previously been studied with cadaveric testing, and more recently, with finite element (FE) methods. FE is a numeric modeling method that provides both qualitative and quantitative data related to stress and strain distribution, contact forces, and displacement field, which may help the understanding of mechanisms and the comparing of different cases.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Comparison of the Biomechanical Effect of the FFX Device Compared With Other Lumbar Fusion Devices: A Finite Element Study

Simon¹,

Millot²,

Hoarau³

et al. 2022

Int J Spine Surg

Self Cite

View full text Add to dashboard Cite

Background: Lumbar decompression can result in postsurgical instability and spondylolisthesis in patients with lumbar spinal stenosis (LSS). While pedicle screw (PS) constructs improve stability and support fusion, their use can lead to adjacent level degeneration due to rigidity and resultant overload of anatomical structures. The FFX device is a facet spacer designed to be a less invasive alternative for obtaining fusion compared with PS.Objective: The present study aimed to compare biomechanical performance of the FFX device to different lumbar spine procedures using the finite element (FE) method.Study Design: Comparative biomechanical study by FE method.Methods: An FE model for the lumbar spine was developed and validated to assess vertebral displacement and stress variations in the facet joints and discs following surgery. Modeled scenarios included a healthy spine as a reference model, laminectomy (LAM), and prior to/following L4-L5 fusion for LAM + FFX and LAM + PS.Results: LAM increased displacement compared with the healthy spine and both instrumented spine procedures. Facet joint stress at adjacent levels for LAM + PS was significantly higher than with LAM + FFX prior to fusion (+13.5% for L3-L4; +15.7% for L5-S1). Adjacent level disc stress at L5-S1 was 7.7% higher for LAM + PS vs LAM + FFX. Adjacent level facet joint and disc stresses for LAM + FFX were equivalent to LAM + PS once fusion occurred.Conclusions: Instrumented spine fixation prevents the risk of lumbar instability associated with LAM alone. Compared with PS, the FFX device is a less invasive alternative for the treatment of LSS, which potentially lowers the risk of adjacent segment degeneration prior to fusion that provides equivalent stability once fusion is achieved.

show abstract

Section: Discussionmentioning

confidence: 66%

Section: Discussionmentioning

confidence: 75%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Comparison of the Biomechanical Effect of the FFX Device Compared With Other Lumbar Fusion Devices: A Finite Element Study

Simon¹,

Millot²,

Hoarau³

et al. 2022

Int J Spine Surg

Self Cite

View full text Add to dashboard Cite

show abstract

“…A recent prospective, single-arm, multicenter study assessed clinical outcomes with the FFX device related to pain reduction and fusion rate in 53 patients with LSS or facet syndrome with and without concomitant posterior lumbar interbody fusion procedures [7]. Mean visual analog scale leg and back pain scores significantly improved from 5.57 to 2.09 (p < 0.001) and 5.74 to 3.13 (p < 0.001), respectively, between the preoperative and one-year follow-up assessments.…”

Section: Discussionmentioning

confidence: 99%

“…The lumbar Facet FiXation (FFX®) device (SC Medica, Strasbourg, France) is a new implantable facet spacer intended to increase foraminal space and promote fusion while reducing load projections on adjacent lumbar levels [7]. The device is designed to prevent facet motion and post-laminectomy instability in patients with LSS while avoiding the rigidity associated with conventional PS constructs.…”

Section: Introductionmentioning

confidence: 99%

Comparison of Operative Time and Blood Loss With the FFX® Device Versus Pedicle Screw Fixation During Surgery for Lumbar Spinal Stenosis: A Retrospective Cohort Study

Srour¹

2022

Cureus

Self Cite

View full text Add to dashboard Cite

BackgroundPedicle screw (PS) placement can be associated with soft tissue damage and blood loss. The study objective was to evaluate differences in operative time and blood loss between PS fixation and an implantable facet fusion device in patients undergoing lumbar fusion surgery. Materials and methodsA retrospective analysis was performed on patients undergoing lumbar fusion surgery with PS fixation or the lumbar Facet FiXation (FFX) device. Procedures were performed by the same surgeon at a single institution. The PS group included patients from 2016 and the FFX group included patients from 2018. Variables including age, sex, levels operated on, operative time, and operative blood loss were collected. ResultsA total of 70 patients were included in the study. Twenty-eight in the PS arm and 42 in the FFX arm. The PS group had a mean age of 67.5 ± 9.3 years compared to 70.4 ± 11.5 years for the FFX group. The PS group had a higher percentage of females (57.1%) versus the FFX group (31.0%); p = 0.025. Mean number of levels operated on were similar between the PS and FFX groups (2.3 ± 1 .1 vs. 2.2 ± 1.0, respectively; p = 0.89). Mean operative time was significantly longer for the PS group versus the FFX group (152.5 ± 39.4 vs. 99.4 ± 44.0 minutes; p < 0.001). Mean operative blood loss was significantly greater for the PS group versus the FFX group (446.5 ± 272.0 vs. 251.0 ± 315.9 mL; p < 0.01). Differences were independent of the number of levels operated on. ConclusionPlacement of the FFX device is associated with a significant reduction in operative time and blood loss compared to PS fixation in patients undergoing spinal fusion surgery.

show abstract

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

Houari,

Douanla,

Ben Ammar

et al. 2024

Clinical Spine Surgery

View full text Add to dashboard Cite

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. Level of evidence: Level III.

show abstract

Facet Arthrodesis with the FFX Device: One-Year Results from a Prospective Multicenter Study

Cited by 6 publications

References 14 publications

Comparison of the Biomechanical Effect of the FFX Device Compared With Other Lumbar Fusion Devices: A Finite Element Study

Comparison of the Biomechanical Effect of the FFX Device Compared With Other Lumbar Fusion Devices: A Finite Element Study

Comparison of Operative Time and Blood Loss With the FFX® Device Versus Pedicle Screw Fixation During Surgery for Lumbar Spinal Stenosis: A Retrospective Cohort Study

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

Contact Info

Product

Resources

About