Feasibility, safety, and efficacy of a new percutaneous interspinous device: a retrospective multicenter study.

PURPOSE: To evaluate safety and efficacy of the novel percutaneous interspinous device (PID) for the treatment of symptomatic degenerative lumbar spinal stenosis (DLSS) in 3 different centers. METHODS: From November 2016 to March 2020, 255 patients (male 125, mean age 71.2 years old range 49-91 years old) with neurogenic claudication, confirmed by electromyography, related to mono or bi-segmental lumbar central canal and/or foraminal stenosis were enrolled in the study. Magnetic resonance (MR) and/or computer tomography (CT), physical exam, and Visual Analogue Scale (VAS) and Zurich Claudication Questionnaire (ZCQ) were performed before and 6 months after the procedure. All treatments were performed under fluoroscopic guidance with local anesthesia and mild sedation. Technical success was defined as correct placement of the Lobster® (Demetrios Medical, Firenze, Italy) PID as demonstrated by computer tomography (CT) performed immediately after treatment; spinoplasty was performed in selected patients. RESULTS: PID placement was accomplished with a 99.6% success rate (257/258). The one device that was not implanted was due to a spinous process fracture. In 28 patients, more than 1 device was implanted in the same session (max 3 PIDs); 6 patients required a second implant in different session. A total of 172 prophylactic spinoplasties were performed (59.3%). No major complications occurred; 3 device misplacements were successfully treated with percutaneous retrieval and new device deployment. 99.6% of patients experienced clinical improvement. CONCLUSION: Lobster PID is an effective and safe minimally invasive decompression method for central canal and neural foraminal stenosis when patients are correctly selected.

What is the role of vertebral augmentation for osteoporotic fractures? A review of the recent literature.

PURPOSE: Vertebral augmentation procedures such as vertebroplasty and kyphoplasty are utilized in the treatment of vertebral compression fractures (VCFs). However, their capacity for providing analgesia, reducing disability, and improving quality of life in patients with osteoporotic VCFs remains a topic of debate. The objective of this narrative review is to summarize the latest evidence for the safety and efficacy of vertebral augmentation for osteoporotic vertebral compression fractures (VCFs). METHODS: A systematic literature search was conducted using the PubMed and Cochrane electronic databases for systematic reviews, review articles, meta-analyses, and randomized clinical trials prior to May 2017. The keywords were "vertebroplasty," "kyphoplasty," and "vertebral augmentation." RESULTS: Thirty-three papers (7 systematic reviews, 6 cohort studies, 15 randomized clinical trials, and 5 international guidelines) were included in this narrative review. CONCLUSION: Vertebral augmentation is a safe procedure, with low rates of serious complications and no increase in subsequent post-treatment fracture risk.

Midterm Clinical and Radiologic Outcomes after Percutaneous Interspinous Spacer Treatment for Neurogenic Intermittent Claudication.

PURPOSE: To evaluate the midterm clinical and radiologic outcome of percutaneous interspinous process spacer (IPS) treatment for neurogenic intermittent claudication (NIC) in patients who fail conservative treatment. METHODS: Consecutive patients with NIC, lumbar spinal stenosis confirmed on magnetic resonance imaging, failure of conservative management for at least 6 months, and treatment with percutaneous IPS were included. Visual analog scale (VAS) and Oswestry Disability Index (ODI) scores were recorded at baseline, 1 month, 1 year and 3 years after treatment. Spinal canal and foraminal cross-sectional areas were calculated from multidetector computed tomography at baseline and 1 year. RESULTS: There were 80 patients treated with 94 IPS devices; 83% of patients received a single IPS; 78% of IPS devices were placed at L4-L5. An IPS dislocation was the single periprocedural major complication. VAS score of 8.1 ± 2 before treatment was reduced to 4.4 ± 2 at 1 month after treatment (P = .0001); ODI score of 23.3 ± 10 before treatment was reduced to 11.7 ± 8.5 at 1 month after treatment (P = .0001). These significant reductions were durable at 1-year and 3-year follow-up evaluations (P < .01). Spinal canal and foraminal cross-sectional area increased by 15% at 1 year (P = .0001). CONCLUSIONS: Patients with NIC who failed conservative treatment and were treated with percutaneous IPS achieved significant gains in pain relief and reduced disability that remained durable at 3-year clinical follow-up evaluation. This outcome was accompanied by significant increases in spinal canal and foraminal cross-sectional areas at the treated level.

Effectiveness of a bone substitute (CERAMENT™) as an alternative to PMMA in percutaneous vertebroplasty: 1-year follow-up on clinical outcome.

PURPOSE: The aim of the study was to evaluate the efficacy of an injectable and partly absorbable calcium bone cement (CERAMENT™, Bone Support, Sweden) in the treatment of osteoporotic or traumatic vertebral fractures by percutaneous vertebroplasty. METHODS: From March 2009 to October 2010 an open, prospective study in two centres was performed. 33 patients with symptomatic vertebral fractures were enrolled. Patients were included based on evaluation by X-ray, CT, and MRI. Clinical evaluation by Visual Analogue Scale (VAS, 0-10) and Oswestry Disability index test (ODI, 0-100 %) was performed before the operation as well as 1, 6 and 12 months after the procedure. Radiology assessment post-procedure was carried out by X-ray, CT, and MRI at 1, 6 and 12 months post-op. Intake of analgesic medications pre- and post-procedure was monitored. RESULTS: 66 vertebral bodies underwent percutaneous vertebroplasty. VAS score demonstrated a significant decrease from 8.61 (SD 19.8) pre-operatively to 2.48 (SD 2.36) at 1 month. The score was 2.76 (SD 2.68) at 6 months and 1.36 (SD 1.33) at the latest follow up. ODI score dropped significantly from 58.86 pre-op to 26.94 at 6 months and further down to 7.61 at 12 months. No re-fractures or adjacent level fractures were reported. CONCLUSION: Data show that CERAMENT can be a substitute of PMMA in the treatment of osteoporotic and traumatic vertebral fractures, especially in young patients.

Efficacy of a Novel Vertebral Body Augmentation System in the Treatment of Patients with Symptomatic Vertebral Body Fractures.

PURPOSE: To evaluate the safety and efficacy of a novel augmentation implant in the treatment of patients with symptomatic vertebral body fractures. MATERIALS AND METHODS: Thirty consecutive patients (seven males and 23 females), mean age of 70 years (range 56 to 89) with osteoporotic fractures and/or low-energy trauma fractures (osteoporosis confirmed by CT), were enrolled in an IRB-approved prospective study. The type of fracture was classified according to the Magerl classification. The patients were treated with the Tektona® dedicated vertebral body augmentation system. Visual analogue scale (VAS) and Oswestry Disability Index (ODI) scores were obtained after 1, 6 and 12 months. Quality of life was assessed with the SF36 score. RESULTS: A total of 37 vertebral bodies, mostly from T6 to L5, were treated in the 30 enrolled patients. In 67.6% of the cases (n = 25), lumbar fractures were treated. Most of the fractures (43%; n = 16) were A1.1 according to the Magerl classification. A significant pain reduction evaluated by VAS scores (p < 0.0001) was observed on average 7.6 (before the procedure) to 2.8 (immediately post-treatment), 2.1 and 2.7 (after 6 and 12 months later, respectively). The mean ODI score was 55.5% before treatment, and this was statistically significant reduced to 22.3% and 26.9%, respectively, at 6 and 12 months after treatment (p < 0.0001). The SF36 scores, both physical and mental components, showed statistically significant variations (p < 0.0001) whose direction was subpopulation dependent. CONCLUSION: Patients with confirmed osteoporosis, suffering from symptomatic vertebral body fractures (osteoporotic and/or low-energy traumatic), were treated safely and effectively using this novel implant.

Efficacy of an ethyl alcohol gel in symptomatic disc herniation.

PURPOSE: To evaluate the clinical outcome of DiscoGel® chemonucleolysis for symptomatic disc herniation in patients who fail conservative treatment. MATERIAL AND METHODS: Consecutive patients with symptomatic disc herniation confirmed on MRI who failed conservative management for at least 6 months were included. Visual analogue scale (VAS), Oswestry Disability Index (ODI) scores, and analgesic use were recorded at baseline, and 12 months after treatment. Multidetector CT (MDCT) was performed at baseline, and 12 months after treatment to assess for DiscoGel® extravasation and alteration in treated disc volume. In a unique long-term subgroup analysis of 31 patients, telephonic follow-up was performed utilizing VAS and ODI parameters 7 years after the procedure. RESULTS: A total of 87 disc herniations were treated in 71 patients; majority (54%) were treated at L4/5 and L5/S1. VAS score of 8 before treatment was reduced to 3 at 12 months after treatment (p = 0.0001); ODI score of 51 before treatment was reduced to 15 at 12 months after treatment (p = 0.0001). Analgesic use of 70.4% was reduced to 29.6% after treatment. There were no symptomatic procedural complications; MDCT revealed 1 asymptomatic peri-neural DiscoGel® extravasation. In the 31 subjects that underwent telephonic follow-up the VAS and ODI parameters maintained their values without statistically significant differences when compared with the 12-month follow-up. CONCLUSION: Patients with symptomatic disc herniation who failed conservative treatment and were treated with DiscoGel® chemonucleolysis achieved significant gains in pain relief and reduced disability without symptomatic complication. DiscoGel® chemonucleolysis is a feasible, minimally invasive technique for treatment of symptomatic disc herniation.

Degenerative lumbar spinal stenosis treatment with Aperius™ PerCLID™ system and Falena® interspinous spacers: 1-year follow-up of clinical outcome and quality of life.

PURPOSE: Evaluation of the efficacy of the Falena(®) and Aperius™ PerCLID™ interspinous devices in the treatment of degenerative lumbar spinal stenosis with neurogenic intermittent claudication refractory to conservative treatment. MATERIALS AND METHODS: We retrospectively analyzed data from 24 patients (20 male and 4 female patients; 61 ± 7 years old), treated with an implantation of the AperiusTM PerCLID™ system, and from 35 patients (29 male and 6 female patients; 65 ± 9 years old) treated with the Falena(®) interspinous device.Patient pain intensity was evaluated by a 10-point visual analog scale (VAS), with a score (ranging from 0 = no pain to 10 = unbearable pain) that was collected before the procedure, at baseline; and at months 1, 6 and 12 after the interventional procedure. The assessment of quality of life (QOL) impairment was evaluated by the Oswestry Disability Index (ODI) questionnaire, which was administered beforehand at baseline; and at months 1, 6 and 12 after the interventional procedure. The vertebral canal area was measured by magnetic resonance imaging (MRI) scans before the treatment and at the one-year follow-up. RESULTS: All patients completed the study with no complications. Both the Falena group and Aperius group of surgery patients showed a statistically significant reduction of their VAS and ODI scores at the 6- and 12-month follow-up (p < 0.0001). A statistically significant increase in the vertebral canal area was observed both in the group that received Falena (p < 0.0001) and in the group that received Aperius (p = 0.0003). At the 1-year follow-up, we observed that there was a higher increase of vertebral canal area in those patients whom were treated with the Falena device (p < 0.001). CONCLUSIONS: The implantation of Falena(®) and Aperius™ PerCLID™ interspinous devices is an effective and safe procedure, in the medium term.

Effectiveness of percutaneous screws for treatment of degenerative lumbar low back pain.

BACKGROUND: The purpose of this retrospective observational study was to demonstrate the efficacy of a percutaneous screws system in the treatment of lumbar pain caused by high-level disc degeneration combined with facet joint hypertrophy and canal stenosis especially in the L5-S1 levels. METHODS: Thirty-eight patients (25 males, 13 females, mean age 63 years) with lumbar pain and/or neuralgia-claudication were treated with interpeduncular dynamic screws. Diagnosis was based on clinical\medical history evaluation and X-ray, CT, and MR examinations. All patients completed the visual analogic scale (VAS) for evaluation of clinical efficacy and pain measurement both before and after (1 month and after 2 years) the procedure. Patients also were given the Oswestry disability index (ODI) before and after treatment. The area of the neuroforamina also was measured. RESULTS: Thirty-eight intervertebral spaces were treated. The VAS pain scale showed a reduction of pain symptoms at 1 month and after 2 years (VAS pre 8.7 ± 1.1; after 1 month 5.1 ± 2.2; after 2 years 6.5 ± 2.1; p = 0.001). ODI also showed improvement (pre 56.7 ± 18.6 %; after 1 month: 31.9 ± 26.3%; after 2 years: 42 ± 24.2 %, p = 0.001). The study showed a widening of the neuroforaminal area of 15.5 % in the right neuroforamen and 17 % in the left ones (right foraminal area pre 0.94 mm(2), post 1.08 mm(2); left foramina area pre 0.95 mm(2), post 1.11 mm(2)). In addition, the spinal canal area displayed a statistically significant reduction (pre = 1.97 and post = 2.23; p < 0.0001). CONCLUSIONS: Our study indicates that patients treated with dynamic screws have VAS pain reduction as well as ODI improvement. Moreover, we found a statistically significant widening of the neuroforaminal area.