{"id":5939,"date":"2024-09-11T11:55:43","date_gmt":"2024-09-11T09:55:43","guid":{"rendered":"https:\/\/sc-medica.com\/publications\/"},"modified":"2026-10-19T09:50:17","modified_gmt":"2026-10-19T07:50:17","slug":"publications","status":"publish","type":"page","link":"https:\/\/sc-medica.com\/en-us\/publications\/","title":{"rendered":"Publications"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"5939\" class=\"elementor elementor-5939 elementor-1656\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-be0c741 e-flex e-con-boxed e-con e-parent\" data-id=\"be0c741\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1b44161 elementor-widget elementor-widget-spacer\" data-id=\"1b44161\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d11db03 elementor-widget elementor-widget-heading\" data-id=\"d11db03\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Clinical Evidence<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b1b4ecd elementor-widget elementor-widget-spacer\" data-id=\"b1b4ecd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d8b9769 elementor-widget elementor-widget-text-editor\" data-id=\"d8b9769\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"scm-ev tinted\"><p class=\"lead\">FFX<span class=\"reg\">\u00ae<\/span> facet cages have been studied in 8 peer-reviewed publications: 6 clinical studies and 2 biomechanical studies. Each study is summarized below with its design, sample size and key results, with a link to the original article.<\/p><nav class=\"toc\"><a href=\"#key-results\">Key results<\/a><a href=\"#ffx-publications\">FFX<span class=\"reg\">\u00ae<\/span> publications<\/a><a href=\"#ongoing-research\">Ongoing research<\/a><a href=\"#diva-publications\">DIVA<span class=\"reg\">\u00ae<\/span> publications<\/a><a href=\"#faq\">FAQ<\/a><\/nav><section class=\"band grey figs-band\"><div class=\"figs\"><div><b>91%<\/b><p>fusion rate<br>on CT scan<\/p><\/div><div><b><i class=\"mn\">&#45;<\/i>35%<\/b><p>operative time<br>vs Pedicle screws<\/p><\/div><div><b><i class=\"mn\">&#45;<\/i>44%<\/b><p>blood loss<br>vs Pedicle screws<\/p><\/div><div><b>19\u00d7<\/b><p>less metal than<br>Pedicle screws<\/p><\/div><\/div><\/section><section class=\"band white\" id=\"key-results\"><h2>Key clinical evidence<\/h2><div class=\"block\"><h3>Fusion rates<\/h3><p class=\"claim\">89% to 91% of FFX<span class=\"reg\">\u00ae<\/span> devices achieve bony fusion of the facet joint on CT scan.<\/p><div class=\"tbl\"><table><thead><tr><th>Study<\/th><th>Population<\/th><th>Follow-up<\/th><th class=\"hl\">Fusion rate<\/th><\/tr><\/thead><tbody><tr><th>Mostofi, 2025<\/th><td>100 patients<\/td><td>12 months<\/td><td class=\"hl\"><b>91%<\/b><\/td><\/tr><tr><th>Houari et al., 2024<\/th><td>252 devices<br>(56 patients)<\/td><td>2+ years<\/td><td class=\"hl\"><b>91%<\/b><small>with FFX<span class=\"reg\">\u00ae<\/span> and its facet screw (45 patients); 89% across all devices<\/small><\/td><\/tr><tr><th>Srour et al., 2020<\/th><td>205 devices<br>(53 patients)<\/td><td>12 months<\/td><td class=\"hl\"><b>89%<\/b><small>standalone, without concomitant PLIF cages (38 patients); 86% across all devices<\/small><\/td><\/tr><\/tbody><\/table><\/div><\/div><div class=\"block\"><h3>FFX<span class=\"reg\">\u00ae<\/span> vs Pedicle screws<\/h3><p class=\"claim\">Shorter surgery and less blood loss than Pedicle screws, with similar clinical results at 2 years.<\/p><div class=\"tbl\"><table><thead><tr><th>Outcome<\/th><th class=\"hl\">FFX<span class=\"reg\">\u00ae<\/span><\/th><th>Pedicle screws<\/th><th>Study<\/th><\/tr><\/thead><tbody><tr><th>Mean operative time<\/th><td class=\"hl\"><b>99 min<\/b><\/td><td>153 min<\/td><td>Srour, 2022<small>70 patients, p &lt;&nbsp;0.001<\/small><\/td><\/tr><tr><th>Mean blood loss<\/th><td class=\"hl\"><b>251 mL<\/b><\/td><td>447 mL<\/td><td>Srour, 2022<small>70 patients, p &lt;&nbsp;0.01<\/small><\/td><\/tr><tr><th>Fusion at 2+ years<\/th><td class=\"hl\"><b>91%<\/b><small>with facet screw; 89% across all devices<\/small><\/td><td>85%<\/td><td>Houari et al., 2024<small>112 patients<\/small><\/td><\/tr><tr><th>Reoperation at 2 years<\/th><td class=\"hl\"><b>3.6%<\/b><\/td><td>10.7%<\/td><td>Houari et al., 2024<small>112 patients, not significant<\/small><\/td><\/tr><\/tbody><\/table><\/div><\/div><div class=\"block\"><h3>Pain and function<\/h3><p class=\"claim\">Pain and disability are roughly halved after FFX<span class=\"reg\">\u00ae<\/span> facet arthrodesis.<\/p><div class=\"tbl\"><table><thead><tr><th>Study<\/th><th>Measure<\/th><th>Before<\/th><th class=\"hl\">After<\/th><th>P<\/th><\/tr><\/thead><tbody><tr><th>Mostofi et al., 2026<small>118 patients, positive injection test, 3 months<\/small><\/th><td><span class=\"lg\">Oswestry Disability Index<\/span><span class=\"sm\">ODI<\/span><\/td><td>70.9<\/td><td class=\"hl\"><b>34.5<\/b><\/td><td>&lt;&nbsp;0.05<\/td><\/tr><tr><th>Mostofi, 2025<small>100 patients, 12 months<\/small><\/th><td><span class=\"lg\">Oswestry Disability Index<\/span><span class=\"sm\">ODI<\/span><br>VAS pain<\/td><td>46<br>7.2<\/td><td class=\"hl\"><b>18<\/b><br><b>2.1<\/b><\/td><td>&lt;&nbsp;0.05<br>&lt;&nbsp;0.05<\/td><\/tr><tr><th>Srour et al., 2020<small>53 patients, 12 months; 93% improved in VAS or Oswestry score<\/small><\/th><td><span class=\"lg\">Oswestry Disability Index<\/span><span class=\"sm\">ODI<\/span><br>Back pain VAS<br>Leg pain VAS<\/td><td>44.7%<br>5.7<br>5.6<\/td><td class=\"hl\"><b>24.0%<\/b><br><b>3.1<\/b><br><b>2.1<\/b><\/td><td>&lt;&nbsp;0.001<br>&lt;&nbsp;0.001<br>&lt;&nbsp;0.001<\/td><\/tr><tr><th>Houari et al., 2024<small>56 FFX<span class=\"reg\">\u00ae<\/span> patients, 2+ years; similar to Pedicle screws<\/small><\/th><td><span class=\"lg\">Oswestry Disability Index<\/span><span class=\"sm\">ODI<\/span><br>Back pain VAS<br>Leg pain VAS<\/td><td>52%<br>6.30<br>5.73<\/td><td class=\"hl\"><b>35%<\/b><br><b>3.45<\/b><br><b>2.38<\/b><\/td><td>&lt;&nbsp;0.001<br>&lt;&nbsp;0.001<br>&lt;&nbsp;0.001<\/td><\/tr><\/tbody><\/table><\/div><\/div><div class=\"block\"><h3>Other findings<\/h3><div class=\"minis\"><div><b>0<\/b><span class=\"u\">serious device-related adverse events<\/span><p>All-cause postoperative complications, mostly transient sciatica, similar to Pedicle screws (16.1% vs 19.6%).<\/p><span class=\"s\">Houari et al., 2024; Srour et al., 2020; Mostofi, 2025<\/span><\/div><div><b>+3.7 mm<\/b><span class=\"u\">foraminal height<\/span><p>Mean increase at 2+ years after surgery vs preoperative (P &lt;&nbsp;0.001).<\/p><span class=\"s\">Houari et al., Clin Spine Surg, 2024<\/span><\/div><div><b>73%<\/b><span class=\"u\">positive medial branch blocks<\/span><p>in lumbar stenosis patients; their back pain improved more after surgery (4.7 vs 1.8 VAS points).<\/p><span class=\"s\">Houari et al., J Craniovertebr Junction Spine, 2025<\/span><\/div><div><b><i class=\"ng\">&#45;<\/i>62%<\/b><span class=\"u\">stress on Pedicle screws<\/span><p>when FFX<span class=\"reg\">\u00ae<\/span> is added to a long construct (L2-S1); -57% in a short construct (L4-L5).<\/p><span class=\"s\">Saddiki et al., Int J Spine Surg, 2025<\/span><\/div><div><b><i class=\"mn\">&#45;<\/i>15.7%<\/b><span class=\"u\">stress on adjacent facets<\/span><p>vs Pedicle screws before fusion (L5-S1; -13.5% at L3-L4); equivalent stability after fusion.<\/p><span class=\"s\">Simon et al., Int J Spine Surg, 2022<\/span><\/div><div><b class=\"txt\">Clinical diagnosis first<\/b><p>Surgical success was largely independent of injection test and SPECT\/CT results; the injection test better predicted functional outcome.<\/p><span class=\"s\">Mostofi et al., J Craniovertebr Junction Spine, 2026<\/span><\/div><\/div><\/div><\/section><section class=\"band grey\" id=\"ffx-publications\"><h2>FFX<span class=\"reg\">\u00ae<\/span> publications<\/h2><p class=\"intro\">Six clinical and two biomechanical studies, most recent first.<\/p><h3 class=\"group\">Clinical studies<\/h3><details class=\"pub\" name=\"scm-pub\"><summary><p class=\"meta\">2026 \u00b7 Clinical study \u00b7 118 patients<\/p><h4>Interarticular device surgery for lumbar facet syndrome: diagnostic and therapeutic significance of injection tests and SPECT\/CT<\/h4><\/summary><div class=\"pub-b\"><p class=\"cite\">Mostofi K, Peyravi M, Shirbacheh A, Shirbache K. <em>J Craniovertebr Junction Spine<\/em>. 2026;17(3):244-250. DOI: 10.4103\/jcvjs.jcvjs_227_25<\/p><p class=\"res\"><b>Key results.<\/b> Oswestry Disability Index improved from 70.9 to 34.5 at 3 months in patients with a positive injection test. Surgical success was largely independent of preoperative injection test and SPECT\/CT results; the injection test predicted functional outcome better than SPECT\/CT.<\/p><p class=\"more\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/42389296\/\" target=\"_blank\" rel=\"noopener\">Read the article<\/a><\/p><\/div><\/details><details class=\"pub\" name=\"scm-pub\"><summary><p class=\"meta\">2025 \u00b7 Retrospective \u00b7 22 patients<\/p><h4>Prevalence and treatment of facet syndrome in patients with lumbar spinal stenosis managed with FFX<span class=\"reg\">\u00ae<\/span> facet cages<\/h4><\/summary><div class=\"pub-b\"><p class=\"cite\">Houari O, Ben Ammar M, Mortada J, Bolognini F, Musacchio M, Lebedenski A, Srour R. <em>J Craniovertebr Junction Spine<\/em>. 2025;16:343-348. DOI: 10.4103\/jcvjs.jcvjs_11_25<\/p><p class=\"res\"><b>Key results.<\/b> 73% of stenosis patients had a positive medial branch block, confirming facet-generated back pain. Back pain improved more in patients with a positive block than in those with a negative block (4.7 vs 1.8 VAS points); leg pain improved similarly in both groups.<\/p><p class=\"more\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/41000486\/\" target=\"_blank\" rel=\"noopener\">Read the article<\/a><\/p><\/div><\/details><details class=\"pub\" name=\"scm-pub\"><summary><p class=\"meta\">2025 \u00b7 Technique and outcomes \u00b7 100 patients<\/p><h4>Minimally invasive lumbar facet arthrodesis with the FFX<span class=\"reg\">\u00ae<\/span> device: surgical anatomy, patient selection, and technique<\/h4><\/summary><div class=\"pub-b\"><p class=\"cite\">Mostofi K. <em>Eur J Orthop Surg Traumatol<\/em>. 2025;35(1):299. DOI: 10.1007\/s00590-025-04425-y<\/p><p class=\"res\"><b>Key results.<\/b> 91% fusion rate at 12 months; mean VAS pain from 7.2 to 2.1 and Oswestry Disability Index from 46 to 18 at 12 months; low complication rate.<\/p><p class=\"more\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/40640578\/\" target=\"_blank\" rel=\"noopener\">Read the article<\/a><\/p><\/div><\/details><details class=\"pub\" name=\"scm-pub\"><summary><p class=\"meta\">2024 \u00b7 Comparative cohort \u00b7 112 patients<\/p><h4>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<\/h4><\/summary><div class=\"pub-b\"><p class=\"cite\">Houari O, Douanla A, Ben Ammar M, et al. <em>Clin Spine Surg<\/em>. 2024. DOI: 10.1097\/BSD.0000000000001704<\/p><p class=\"res\"><b>Key results.<\/b> Bony fusion at 2+ years in 91% of patients treated with FFX<span class=\"reg\">\u00ae<\/span> and its facet screw (45 patients); 89% across all 252 FFX<span class=\"reg\">\u00ae<\/span> devices implanted vs 85% with Pedicle screws. Mean foraminal height increased by 3.7 mm. Reoperation 3.6% with FFX<span class=\"reg\">\u00ae<\/span> vs 10.7% with Pedicle screws (not statistically significant). VAS and Oswestry scores improved significantly in both groups, with no difference between groups.<\/p><p class=\"more\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/39404118\/\" target=\"_blank\" rel=\"noopener\">Read the article<\/a><\/p><\/div><\/details><details class=\"pub\" name=\"scm-pub\"><summary><p class=\"meta\">2022 \u00b7 Retrospective cohort \u00b7 70 patients<\/p><h4>Comparison of operative time and blood loss with the FFX<span class=\"reg\">\u00ae<\/span> device versus pedicle screw fixation during surgery for lumbar spinal stenosis: a retrospective cohort study<\/h4><\/summary><div class=\"pub-b\"><p class=\"cite\">Srour R. <em>Cureus<\/em>. 2022;14(3):e22931. DOI: 10.7759\/cureus.22931<\/p><p class=\"res\"><b>Key results.<\/b> Mean operative time 99 min vs 153 min (p &lt;&nbsp;0.001); mean blood loss 251 mL vs 447 mL (p &lt;&nbsp;0.01).<\/p><p class=\"more\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/35399487\/\" target=\"_blank\" rel=\"noopener\">Read the article<\/a><\/p><\/div><\/details><details class=\"pub\" name=\"scm-pub\"><summary><p class=\"meta\">2020 \u00b7 Prospective multicenter \u00b7 53 patients<\/p><h4>Facet arthrodesis with the FFX device: one-year results from a prospective multicenter study<\/h4><\/summary><div class=\"pub-b\"><p class=\"cite\">Srour R, Gdoura Y, Delaitre M, et al. <em>Int J Spine Surg<\/em>. 2020;14(6):996-1002. DOI: 10.14444\/7149<\/p><p class=\"res\"><b>Key results.<\/b> 86.3% of implanted devices showed facet fusion at 12 months (88.7% in patients without concomitant PLIF cages). Leg pain VAS from 5.6 to 2.1, back pain VAS from 5.7 to 3.1, Oswestry Disability Index from 44.7% to 24.0% (all p &lt;&nbsp;0.001); 93% of patients improved in VAS or Oswestry score. No surgical complication and no revision surgery.<\/p><p class=\"more\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/33560260\/\" target=\"_blank\" rel=\"noopener\">Read the article<\/a><\/p><\/div><\/details><h3 class=\"group\">Biomechanical studies<\/h3><details class=\"pub\" name=\"scm-pub\"><summary><p class=\"meta\">2025 \u00b7 Finite element<\/p><h4>Biomechanical effect of a lumbar interfacet cage (FFX) device when combined with pedicle screw constructs: a finite element study<\/h4><\/summary><div class=\"pub-b\"><p class=\"cite\">Saddiki R, Dhenin A, Montron L, et al. <em>Int J Spine Surg<\/em>. 2025. DOI: 10.14444\/8826<\/p><p class=\"res\"><b>Key results.<\/b> Adding FFX<span class=\"reg\">\u00ae<\/span> to Pedicle screws reduced the stress on the screws by 57% in a short construct (L4-L5) and by 62% in a long construct (L2-S1).<\/p><p class=\"more\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/41371947\/\" target=\"_blank\" rel=\"noopener\">Read the article<\/a><\/p><\/div><\/details><details class=\"pub\" name=\"scm-pub\"><summary><p class=\"meta\">2022 \u00b7 Finite element<\/p><h4>Comparison of the biomechanical effect of the FFX device compared with other lumbar fusion devices: a finite element study<\/h4><\/summary><div class=\"pub-b\"><p class=\"cite\">Simon L, Millot F, Hoarau X, et al. <em>Int J Spine Surg<\/em>. 2022;16(5):935-943. DOI: 10.14444\/8355<\/p><p class=\"res\"><b>Key results.<\/b> Before fusion, stress on the facets of the adjacent levels was up to 15.7% lower with FFX<span class=\"reg\">\u00ae<\/span> (13.5% lower at L3-L4, 15.7% lower at L5-S1), and adjacent disc stress at L5-S1 was 7.7% higher with Pedicle screws. After fusion, both constructs provided equivalent stability.<\/p><p class=\"more\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/35940636\/\" target=\"_blank\" rel=\"noopener\">Read the article<\/a><\/p><\/div><\/details><\/section><section class=\"band white\" id=\"ongoing-research\"><h2>Ongoing research<\/h2><div class=\"rct\"><div class=\"rct-n\"><b>RCT<\/b><p>Randomized controlled trial<\/p><\/div><div class=\"rct-b\"><p class=\"meta\"><span class=\"badge\">Ongoing<\/span>Superiority \u00b7 Multicenter \u00b7 320 patients planned<\/p><h4><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT06106061\" target=\"_blank\" rel=\"noopener\">FFX<span class=\"reg\">\u00ae<\/span> RCT: effectiveness and safety of the facet fixation (FFX<span class=\"reg\">\u00ae<\/span>) implant in the treatment of degenerative lumbar spinal stenosis<\/a><\/h4><p>Decompression plus FFX<span class=\"reg\">\u00ae<\/span> vs decompression alone, 1 to 3 levels (L1 to S1). Primary endpoint: composite clinical success at 2 years (back pain reduction of more than 20 mm on the VAS, no reoperation at the index level, no additional lumbar treatment).<\/p><p class=\"cite\">Sponsor: SC MEDICA. ClinicalTrials.gov: NCT06106061<\/p><\/div><\/div><\/section><section class=\"band grey\" id=\"diva-publications\"><h2>DIVA<span class=\"reg\">\u00ae<\/span> publications<\/h2><details class=\"pub\" name=\"scm-pub\"><summary><p class=\"meta\">2025 \u00b7 In vitro \u00b7 60,000 cycles<\/p><h4>In vitro biomechanical evaluation of a strutted intradiscal spacer for lumbar discectomy<\/h4><\/summary><div class=\"pub-b\"><p class=\"cite\">Schmoelz W, et al. <em>Clin Biomech<\/em>. 2025;124:106491.<\/p><p class=\"res\"><b>Key results.<\/b> Compared with discectomy alone, smaller increase in range of motion in all three planes and less disc height loss; no subsidence or migration of the device.<\/p><p class=\"more\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/40121997\/\" target=\"_blank\" rel=\"noopener\">Read the article<\/a><\/p><\/div><\/details><details class=\"pub\" name=\"scm-pub\"><summary><p class=\"meta\">2021 \u00b7 Matched cohort \u00b7 245 patients<\/p><h4>Effect of a strutted intradiscal spacer (DIVA<span class=\"reg\">\u00ae<\/span>) on disc reherniation following lumbar discectomy: a 2-year retrospective matched cohort study<\/h4><\/summary><div class=\"pub-b\"><p class=\"cite\">Srour R, et al. <em>J Orthop<\/em>. 2021;25:173-178.<\/p><p class=\"res\"><b>Key results.<\/b> Reoperation for same-level reherniation 0.9% with DIVA<span class=\"reg\">\u00ae<\/span> vs 9.8% with discectomy alone (P = 0.0032); all-cause reoperation 4.5% vs 11.3% (P = 0.055); pain and disability improved similarly in both groups.<\/p><p class=\"more\"><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/34025061\/\" target=\"_blank\" rel=\"noopener\">Read the article<\/a><\/p><\/div><\/details><\/section><section class=\"band white\" id=\"faq\"><h2>Frequently asked questions<\/h2><div class=\"faq\"><details name=\"scm-faq\"><summary>How effective is facet arthrodesis (facet fusion)?<\/summary><div class=\"ans\"><p>In published studies, most patients treated with FFX<span class=\"reg\">\u00ae<\/span> facet arthrodesis report clearly less pain and better function one year after surgery, and most implants achieve bony fusion of the facet joint.<\/p><p>In a prospective multicenter study, 93% of patients improved on pain or disability scores at 12 months, and disability (Oswestry score) fell by almost half, from 44.7% to 24.0%. In a series of 100 patients, average pain fell from 7.2 to 2.1 out of 10.<\/p><p>Fusion of the facet joints was confirmed on CT scan in 89% to 91% of devices, depending on the study.<\/p><p class=\"ev\">Srour et al., Int J Spine Surg, 2020; Mostofi, Eur J Orthop Surg Traumatol, 2025; Houari et al., Clin Spine Surg, 2024.<\/p><\/div><\/details><details name=\"scm-faq\"><summary>What is the fusion rate with a facet cage?<\/summary><div class=\"ans\"><p>With the FFX<span class=\"reg\">\u00ae<\/span> facet cage, published fusion rates range from 89% to 91%, assessed on CT scan from 12 months to more than 2 years after surgery.<\/p><p>In the first prospective multicenter study, 89% of devices were fused at 12 months when FFX<span class=\"reg\">\u00ae<\/span> was used standalone, without interbody (PLIF) cages, and 86% across all 205 devices. In a comparative study, 91% were fused at 2+ years when FFX<span class=\"reg\">\u00ae<\/span> was used with its facet screw, and 89% across all 252 devices. A series of 100 patients reported a 91% fusion rate at 12 months.<\/p><p class=\"ev\">Houari et al., Clin Spine Surg, 2024; Mostofi, Eur J Orthop Surg Traumatol, 2025; Srour et al., Int J Spine Surg, 2020.<\/p><\/div><\/details><details name=\"scm-faq\"><summary>Can FFX<span class=\"reg\">\u00ae<\/span> be used without Pedicle screws?<\/summary><div class=\"ans\"><p>Yes. FFX<span class=\"reg\">\u00ae<\/span> is authorized for use on its own, without Pedicle screws, including in patients with moderate instability up to grade I spondylolisthesis. It is also the first facet cage FDA cleared for standalone use. The instructions for use give the full indications and contraindications.<\/p><p>This matters because Pedicle screws are the most invasive part of a conventional fusion. In the published comparative studies, patients with lumbar spinal stenosis were treated with decompression and FFX<span class=\"reg\">\u00ae<\/span> instead of Pedicle screws, with shorter surgery, less blood loss and similar clinical improvement at 2 years.<\/p><p>It also means much less hardware: a single-level FFX<span class=\"reg\">\u00ae<\/span> construct contains about 19 times less implant metal than a single-level Pedicle screw construct (SC MEDICA calculation based on the most frequently implanted sizes).<\/p><p>Pedicle screw fixation remains the option for higher-grade spondylolisthesis, gross instability or deformity.<\/p><p class=\"ev\">Srour, Cureus, 2022; Houari et al., Clin Spine Surg, 2024.<\/p><\/div><\/details><details name=\"scm-faq\"><summary>How does facet arthrodesis compare with Pedicle screw fusion?<\/summary><div class=\"ans\"><p>Facet arthrodesis with FFX<span class=\"reg\">\u00ae<\/span> stabilizes the spine with far less hardware than Pedicle screw fusion, and comparative studies show a shorter, less bloody operation with similar results at 2 years.<\/p><p>A single-level FFX<span class=\"reg\">\u00ae<\/span> construct (2 facet cages and 2 facet screws) contains about 19 times less implant metal than a single-level Pedicle screw construct (4 screws, 4 locking caps and 2 rods), according to SC MEDICA&#8217;s calculation based on the most frequently implanted sizes. This is the <a class=\"scm-mvl\" href=\"\/en-us\/minvi\/\">MiNVI principle<\/a>: the minimum instrumentation needed to reach fusion.<\/p><p>In a cohort of 70 patients, surgery took 99 minutes on average with FFX<span class=\"reg\">\u00ae<\/span> vs 153 minutes with Pedicle screws, and blood loss was 251 mL vs 447 mL. In a cohort of 112 patients, clinical improvement at 2 years was similar in both groups; reoperation was 3.6% with FFX<span class=\"reg\">\u00ae<\/span> vs 10.7% with Pedicle screws, a difference that was not statistically significant.<\/p><p class=\"ev\">Srour, Cureus, 2022; Houari et al., Clin Spine Surg, 2024.<\/p><\/div><\/details><details name=\"scm-faq\"><summary>Were the FFX<span class=\"reg\">\u00ae<\/span> studies conducted in lumbar spinal stenosis?<\/summary><div class=\"ans\"><p>Yes. Most published studies with FFX<span class=\"reg\">\u00ae<\/span> were conducted in patients undergoing decompression for lumbar spinal stenosis. In the U.S., FFX<span class=\"reg\">\u00ae<\/span> is FDA cleared for lumbar degenerative disc disease and\/or degenerative facet disease with instability, from L3 to S1.<\/p><p class=\"ev\">Srour et al., Int J Spine Surg, 2020; Houari et al., Clin Spine Surg, 2024; Houari et al., J Craniovertebr Junction Spine, 2025.<\/p><\/div><\/details><details name=\"scm-faq\"><summary>Does a positive medial branch block predict the outcome of facet arthrodesis?<\/summary><div class=\"ans\"><p>A positive block helps, but it is not a gate. Patients with a positive block recover best functionally, yet patients with a negative block can also benefit from facet arthrodesis when the clinical diagnosis of facet syndrome is clear.<\/p><p>In a study of 118 patients, all were first selected on clinical grounds: pain on hyperextension, pain on palpation of the facet joints and imaging signs of facet disease. The injection test and SPECT\/CT came afterwards. Pain and disability improved significantly in all patient groups, including patients with negative tests, while a positive injection test was associated with greater functional recovery (P = 0.049). A negative test therefore did not identify patients who failed to benefit from surgery. One possible explanation, not tested in the study, is the known limited sensitivity of these tests.<\/p><p>In practice, these results suggest that facet blocks are useful in the workup but should not, on their own, exclude a patient with a clear clinical diagnosis of facet syndrome. Larger studies are needed to confirm this.<\/p><p class=\"ev\">Mostofi et al., J Craniovertebr Junction Spine, 2026; Houari et al., J Craniovertebr Junction Spine, 2025.<\/p><\/div><\/details><details name=\"scm-faq\"><summary>Is facet arthrodesis an option after failed radiofrequency ablation?<\/summary><div class=\"ans\"><p>It can be, depending on what the workup finds. When facet pain keeps coming back despite injections and radiofrequency ablation, the next step is to look for an underlying segmental instability, for example on flexion-extension radiographs.<\/p><p>Radiofrequency ablation gives temporary relief because the medial branch nerves regenerate, and it does not treat instability. When instability is confirmed, FFX<span class=\"reg\">\u00ae<\/span> can be considered to treat degenerative facet disease with instability by fusing the facet joints.<\/p><\/div><\/details><details name=\"scm-faq\"><summary>Is there randomized evidence on facet arthrodesis with FFX<span class=\"reg\">\u00ae<\/span>?<\/summary><div class=\"ans\"><p>A randomized trial is under way. It tests whether adding FFX<span class=\"reg\">\u00ae<\/span> to decompression is superior to decompression alone in 320 patients with lumbar spinal stenosis (ClinicalTrials.gov NCT06106061).<\/p><p>Published evidence to date includes a prospective multicenter study, comparative cohorts and biomechanical studies.<\/p><\/div><\/details><\/div><\/section><p class=\"disclaimer\">As with all medical devices, there are risks and considerations to device use. Please refer to the device labeling for a full discussion of potential risks, contraindications, warnings, precautions, and instructions for use. The information presented on this website is intended only as a brief summary for visitor convenience. Not all products or indications are cleared in every country and may be subject to further local variations. For specific product information, you should always consult the local product documentation. For advice on medical issues, you should always consult your local medical practitioner.<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7c7bc16 elementor-widget elementor-widget-html\" data-id=\"7c7bc16\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>.scm-ev b .mn{font-style:normal;margin-right:.1em}.scm-ev a.scm-mvl{color:#42548E;font-weight:700;text-decoration:underline;text-decoration-color:#00B8D4;text-decoration-thickness:2px;text-underline-offset:4px;transition:color .2s}.scm-ev a.scm-mvl:hover{color:#00A9C4!important}.elementor-5939 .elementor-element-be0c741{background:#fff!important}.elementor-5939 .elementor-element-d11db03 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type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"How effective is facet arthrodesis (facet fusion)?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"In published studies, most patients treated with FFX\u00ae facet arthrodesis report clearly less pain and better function one year after surgery, and most implants achieve bony fusion of the facet joint. In a prospective multicenter study, 93% of patients improved on pain or disability scores at 12 months, and disability (Oswestry score) fell by almost half, from 44.7% to 24.0%. In a series of 100 patients, average pain fell from 7.2 to 2.1 out of 10. Fusion of the facet joints was confirmed on CT scan in 89% to 91% of devices, depending on the study. Srour et al., Int J Spine Surg, 2020; Mostofi, Eur J Orthop Surg Traumatol, 2025; Houari et al., Clin Spine Surg, 2024.\"}},{\"@type\":\"Question\",\"name\":\"What is the fusion rate with a facet cage?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"With the FFX\u00ae facet cage, published fusion rates range from 89% to 91%, assessed on CT scan from 12 months to more than 2 years after surgery. In the first prospective multicenter study, 89% of devices were fused at 12 months when FFX\u00ae was used standalone, without interbody (PLIF) cages, and 86% across all 205 devices. In a comparative study, 91% were fused at 2+ years when FFX\u00ae was used with its facet screw, and 89% across all 252 devices. A series of 100 patients reported a 91% fusion rate at 12 months. Houari et al., Clin Spine Surg, 2024; Mostofi, Eur J Orthop Surg Traumatol, 2025; Srour et al., Int J Spine Surg, 2020.\"}},{\"@type\":\"Question\",\"name\":\"Can FFX\u00ae be used without Pedicle screws?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes. FFX\u00ae is authorized for use on its own, without Pedicle screws, including in patients with moderate instability up to grade I spondylolisthesis. It is also the first facet cage FDA cleared for standalone use. The instructions for use give the full indications and contraindications. This matters because Pedicle screws are the most invasive part of a conventional fusion. In the published comparative studies, patients with lumbar spinal stenosis were treated with decompression and FFX\u00ae instead of Pedicle screws, with shorter surgery, less blood loss and similar clinical improvement at 2 years. It also means much less hardware: a single-level FFX\u00ae construct contains about 19 times less implant metal than a single-level Pedicle screw construct (SC MEDICA calculation based on the most frequently implanted sizes). Pedicle screw fixation remains the option for higher-grade spondylolisthesis, gross instability or deformity. Srour, Cureus, 2022; Houari et al., Clin Spine Surg, 2024.\"}},{\"@type\":\"Question\",\"name\":\"How does facet arthrodesis compare with Pedicle screw fusion?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Facet arthrodesis with FFX\u00ae stabilizes the spine with far less hardware than Pedicle screw fusion, and comparative studies show a shorter, less bloody operation with similar results at 2 years. A single-level FFX\u00ae construct (2 facet cages and 2 facet screws) contains about 19 times less implant metal than a single-level Pedicle screw construct (4 screws, 4 locking caps and 2 rods), according to SC MEDICA's calculation based on the most frequently implanted sizes. This is the MiNVI principle: the minimum instrumentation needed to reach fusion. In a cohort of 70 patients, surgery took 99 minutes on average with FFX\u00ae vs 153 minutes with Pedicle screws, and blood loss was 251 mL vs 447 mL. In a cohort of 112 patients, clinical improvement at 2 years was similar in both groups; reoperation was 3.6% with FFX\u00ae vs 10.7% with Pedicle screws, a difference that was not statistically significant. Srour, Cureus, 2022; Houari et al., Clin Spine Surg, 2024.\"}},{\"@type\":\"Question\",\"name\":\"Were the FFX\u00ae studies conducted in lumbar spinal stenosis?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes. Most published studies with FFX\u00ae were conducted in patients undergoing decompression for lumbar spinal stenosis. In the U.S., FFX\u00ae is FDA cleared for lumbar degenerative disc disease and\/or degenerative facet disease with instability, from L3 to S1. Srour et al., Int J Spine Surg, 2020; Houari et al., Clin Spine Surg, 2024; Houari et al., J Craniovertebr Junction Spine, 2025.\"}},{\"@type\":\"Question\",\"name\":\"Does a positive medial branch block predict the outcome of facet arthrodesis?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"A positive block helps, but it is not a gate. Patients with a positive block recover best functionally, yet patients with a negative block can also benefit from facet arthrodesis when the clinical diagnosis of facet syndrome is clear. In a study of 118 patients, all were first selected on clinical grounds: pain on hyperextension, pain on palpation of the facet joints and imaging signs of facet disease. The injection test and SPECT\/CT came afterwards. Pain and disability improved significantly in all patient groups, including patients with negative tests, while a positive injection test was associated with greater functional recovery (P = 0.049). A negative test therefore did not identify patients who failed to benefit from surgery. One possible explanation, not tested in the study, is the known limited sensitivity of these tests. In practice, these results suggest that facet blocks are useful in the workup but should not, on their own, exclude a patient with a clear clinical diagnosis of facet syndrome. Larger studies are needed to confirm this. Mostofi et al., J Craniovertebr Junction Spine, 2026; Houari et al., J Craniovertebr Junction Spine, 2025.\"}},{\"@type\":\"Question\",\"name\":\"Is facet arthrodesis an option after failed radiofrequency ablation?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"It can be, depending on what the workup finds. When facet pain keeps coming back despite injections and radiofrequency ablation, the next step is to look for an underlying segmental instability, for example on flexion-extension radiographs. Radiofrequency ablation gives temporary relief because the medial branch nerves regenerate, and it does not treat instability. When instability is confirmed, FFX\u00ae can be considered to treat degenerative facet disease with instability by fusing the facet joints.\"}},{\"@type\":\"Question\",\"name\":\"Is there randomized evidence on facet arthrodesis with FFX\u00ae?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"A randomized trial is under way. It tests whether adding FFX\u00ae to decompression is superior to decompression alone in 320 patients with lumbar spinal stenosis (ClinicalTrials.gov NCT06106061). Published evidence to date includes a prospective multicenter study, comparative cohorts and biomechanical studies.\"}}]}<\/script>\n<script>document.addEventListener('DOMContentLoaded',function(){var d=document.querySelectorAll('.scm-ev .faq details');d.forEach(function(x){x.addEventListener('toggle',function(){if(x.open)d.forEach(function(o){if(o!==x)o.open=false;});});});});document.addEventListener('DOMContentLoaded',function(){var d=document.querySelectorAll('.scm-ev details.pub');d.forEach(function(x){x.addEventListener('toggle',function(){if(x.open)d.forEach(function(o){if(o!==x)o.open=false;});});});});document.addEventListener('DOMContentLoaded',function(){var root=document.querySelector('.scm-ev'),nav=root&&root.querySelector('.toc');if(!nav)return;\nvar bar=document.createElement('div');bar.className='scm-stick';bar.innerHTML='<nav class=\"toc\">'+nav.innerHTML+'<\/nav>';root.appendChild(bar);\nvar navs=[nav,bar.querySelector('.toc')],secs=[].map.call(nav.querySelectorAll('a'),function(a){return document.querySelector(a.getAttribute('href'));});\nfunction hb(){var b=0;document.querySelectorAll('.sticky-header,#wpadminbar').forEach(function(h){var p=getComputedStyle(h).position;if(p==='fixed'||p==='sticky'){var r=h.getBoundingClientRect();if(r.bottom>b&&r.top<120)b=r.bottom;}});return b;}\nfunction upd(){var t=hb();bar.style.top=t+'px';bar.classList.toggle('on',nav.getBoundingClientRect().bottom<t);var lim=t+bar.offsetHeight+60,cur=-1;\nsecs.forEach(function(s,i){if(s&&s.getBoundingClientRect().top<lim)cur=i;});navs.forEach(function(n){[].forEach.call(n.querySelectorAll('a'),function(a,i){a.classList.toggle('act',i===cur);});});}\nnavs.forEach(function(n){n.addEventListener('click',function(e){var a=e.target.closest('a');if(!a)return;var s=document.querySelector(a.getAttribute('href'));if(!s)return;e.preventDefault();\nwindow.scrollTo({top:s.getBoundingClientRect().top+window.pageYOffset-hb()-bar.offsetHeight-12,behavior:'smooth'});});});\nwindow.addEventListener('scroll',upd,{passive:true});window.addEventListener('resize',upd);upd();});<\/script>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-233c2d0 elementor-widget elementor-widget-spacer\" data-id=\"233c2d0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Clinical Evidence FFX\u00ae facet cages have been studied in 8 peer-reviewed publications: 6 clinical studies and 2 biomechanical studies. Each study is summarized below with its design, sample size and key results, with a link to the original article. Key resultsFFX\u00ae publicationsOngoing researchDIVA\u00ae publicationsFAQ 91% fusion rateon CT scan &#45;35% operative timevs Pedicle screws &#45;44% [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":0,"menu_order":5,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"class_list":["post-5939","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FFX\u00ae Clinical Evidence: 91% Fusion with Facet Cage Arthrodesis | SC MEDICA<\/title>\n<meta name=\"description\" content=\"FFX\u00ae facet arthrodesis clinical evidence: 91% fusion on CT scan, 35% shorter surgery and 44% less blood loss than Pedicle screws.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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