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• W4386041624 abstract "BACKGROUND CONTEXT Strong innervation of the vertebral endplates by the basivertebral nerve makes it an ideal target for ablation in the treatment of vertebrogenic low back pain with Modic changes. This data represents the preliminary clinical outcomes at 12 months for 12 of the 16 patients treated in a community setting (ClinicalTrials.gov Ref #NCT05692440). PURPOSE This is an independent prospective, noninterventional, single arm post-market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with intraosseous basivertebral nerve ablation using the Intracept Procedure at a single study site. STUDY DESIGN/SETTING Participants in the study will have three study visits over a period of 1-year (one prior to procedure and two after their procedure). Study visits will be conducted in person by the principal investigator and/or authorized and trained clinical research coordinators at the study site. Participants will be consented and evaluated for inclusion/exclusion criteria and a baseline collect at the initial visit (prior to procedure). Participants will be followed post intraosseous basivertebral nerve ablation at 6 and 12 months. PATIENT SAMPLE This data represents the preliminary clinical outcomes at 12 months for 12 of the 16 patients treated in a community setting (ClinicalTrials.gov Ref #NCT05692440). OUTCOME MEASURES Primary objectives are based on patient reported outcomes for functional improvement (Oswestry Disability Index) and low back pain reduction (Visual Analog Scale). METHODS Basivertebral nerve ablations were performed on 16 consecutive patients by a single surgeon (WS) utilizing the INTRACEPT® device (Relievant Medsystems, Inc.). Evaluations were performed at baseline, 1 month, 3 months, 6 months and 12 months and data recorded in Medrio electronic data capture software. The 6 months follow-up data were recently published by our group [Schnapp et al. 2023], and we here present the preliminary 12-months follow-up data obtained on 12 patients. RESULTS The improvements in the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) we observed at 6 months [Schnapp et al. 2023] were sustained at 12 months. The ODI at 12 months was down to 25.8±17.1% (p<0.006) and the VAS was down to 4.5±2.0cm (p<0.032). CONCLUSIONS Basivertebral nerve ablation appears to be a minimally invasive treatment for the relief of chronic low back pain that can be successfully implemented in a community practice setting. Its effects appear sustained for at least 12 months. To our knowledge, this is the first independently funded US study on basivertebral nerve ablation. FDA Device/Drug Status INTEACEPT® procedure is cleared by the FDA. Strong innervation of the vertebral endplates by the basivertebral nerve makes it an ideal target for ablation in the treatment of vertebrogenic low back pain with Modic changes. This data represents the preliminary clinical outcomes at 12 months for 12 of the 16 patients treated in a community setting (ClinicalTrials.gov Ref #NCT05692440). This is an independent prospective, noninterventional, single arm post-market data collection of the patient-reported effectiveness, ongoing safety, and satisfaction outcomes for patients treated with intraosseous basivertebral nerve ablation using the Intracept Procedure at a single study site. Participants in the study will have three study visits over a period of 1-year (one prior to procedure and two after their procedure). Study visits will be conducted in person by the principal investigator and/or authorized and trained clinical research coordinators at the study site. Participants will be consented and evaluated for inclusion/exclusion criteria and a baseline collect at the initial visit (prior to procedure). Participants will be followed post intraosseous basivertebral nerve ablation at 6 and 12 months. This data represents the preliminary clinical outcomes at 12 months for 12 of the 16 patients treated in a community setting (ClinicalTrials.gov Ref #NCT05692440). Primary objectives are based on patient reported outcomes for functional improvement (Oswestry Disability Index) and low back pain reduction (Visual Analog Scale). Basivertebral nerve ablations were performed on 16 consecutive patients by a single surgeon (WS) utilizing the INTRACEPT® device (Relievant Medsystems, Inc.). Evaluations were performed at baseline, 1 month, 3 months, 6 months and 12 months and data recorded in Medrio electronic data capture software. The 6 months follow-up data were recently published by our group [Schnapp et al. 2023], and we here present the preliminary 12-months follow-up data obtained on 12 patients. The improvements in the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) we observed at 6 months [Schnapp et al. 2023] were sustained at 12 months. The ODI at 12 months was down to 25.8±17.1% (p<0.006) and the VAS was down to 4.5±2.0cm (p<0.032). Basivertebral nerve ablation appears to be a minimally invasive treatment for the relief of chronic low back pain that can be successfully implemented in a community practice setting. Its effects appear sustained for at least 12 months. To our knowledge, this is the first independently funded US study on basivertebral nerve ablation." @default.
• W4386041624 created "2023-08-22" @default.
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• W4386041624 date "2023-09-01" @default.
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• W4386041624 title "P58. Basivertebral nerve ablation for the treatment of chronic low back pain with modic changes in a community practice setting: 12-months follow-up" @default.
• W4386041624 doi "https://doi.org/10.1016/j.spinee.2023.06.283" @default.
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