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Browsing by Subject "Degenerative disc disease"
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Item Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study(Springer, 2019-04-30) Fischgrund, Jeffrey S.; Rhyne, Alfred; Franke, Jörg; Sasso, Rick; Kitchel, Scott; Bae, Hyun; Yeung, Christopher; Truumees, Eeric; Schaufele, Michael; Yuan, Philip; Vajkoczy, Peter; DePalma, Michael; Anderson, David G.; Thibodeau, Lee; Meyer, Bernhard; Orthopaedic Surgery, School of MedicinePurposeTo evaluate the safety and efficacy of radiofrequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of chronic low back pain (CLBP) in a Food and Drug Administration approved Investigational Device Exemption trial. The BVN has been shown to innervate endplate nociceptors which are thought to be a source of CLBP.MethodsA total of 225 patients diagnosed with CLBP were randomized to either a sham (78 patients) or treatment (147 patients) intervention. The mean age within the study was 47 years (range 25–69) and the mean baseline ODI was 42. All patients had Type I or Type II Modic changes of the treated vertebral bodies. Patients were evaluated preoperatively, and at 2 weeks, 6 weeks and 3, 6 and 12 months postoperatively. The primary endpoint was the comparative change in ODI from baseline to 3 months.ResultsAt 3 months, the average ODI in the treatment arm decreased 20.5 points, as compared to a 15.2 point decrease in the sham arm (p = 0.019, per-protocol population). A responder analysis based on ODI decrease ≥ 10 points showed that 75.6% of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months.ConclusionPatients treated with RF ablation of the BVN for CLBP exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain.Graphical abstract These slides can be retrieved under Electronic Supplementary Material. Open image in new windowItem Transforaminal lumbar interbody fusion with a silicon nitride cage demonstrates early radiographic fusion(AME, 2022) Gray, Mitchell T.; Davis, Kyle P.; McEntire, Bryan J.; Bal, B. Sonny; Smith, Micah W.; Otolaryngology -- Head and Neck Surgery, School of MedicineBackground: Degeneration of the lumbar spine is common in aging adults and reflects a significant morbidity burden in this population. In selected patients that prove unresponsive to non-surgical treatment, posterior lumbar fusion (PLF) surgery, with or without adjunctive transforaminal lumbar interbody fusion (TLIF) can relieve pain and improve function. We describe here the radiographic fusion rates for PLF versus TLIF, using an intervertebral spinal cage made of silicon nitride ceramic (chemical formula Si3N4). Methods: This retrospective cohort analysis enrolled 99 patients from August 2013 to January 2017; 17 had undergone PLF at 24 levels, while 82 had undergone TLIF at 104 levels. All operations were performed by a single surgeon at one institution. Radiographic and clinical outcomes were compared between PLF and TLIF at 2 and 6 weeks and then at 3, 6, 12, and 24 months. Results: TLIF patients fused at higher rates compared to PLF at the 3-month (38.5% vs. 8.3%, P=0.006), 6-month (78.7% vs. 35.0%, P<0.001) and 12-month time periods (97.9% vs. 81.3%, P=0.018), with no difference at 24 months (100% vs. 94.4%, P=0.102). Index level segmental motion was significantly less and intervertebral disc height was improved in TLIF over PLF at all follow up intervals. Foraminal height was only greater in early follow up periods (2 weeks, 6 weeks and 3 months). TLIF patients experienced lover rates of PI-LL mismatch which was maintained across long term follow-up. Pelvic tilt was lower following TLIF compared to PLF, with no differences in complication rates between study groups. Conclusions: Our retrospective series demonstrated that TLIF performed with silicon nitride interbody cages led to earlier radiographic fusion, greater restoration of disc and foraminal height, increased segmental rigidity and improved sagittal alignment when compared to PLF alone.