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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.

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Objective: The aim of this study is to explain the technique used for removing and replacing a novel percutaneous interspinous device (PID).Procedure: Three male patients, with a mean age of 66 years (range 62-72), were included in the study due to displacement (N = 2) or misplacement (N = 1) of the novel PID. This occurred after a mean of 23.3 ± 10.5 days from the initial placement (range 13-34) at the L4-L5 level (N = 1) and L3-L4 level (N = 2). Following the removal of the PID, four new devices were implanted.Conclusion: The novel PID can be safely removed either immediately after its placement during the procedure or after a certain period of days or months from its implantation. The removal procedure can be performed percutaneously under imaging guidance, by closing the four retractable wings, using the same instrumentation as utilized during the initial implantation.

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Vertebral augmentation has been used to treat painful vertebral compression fractures and metastatic lesions in millions of patients around the world. An international group of subject matter experts have considered the evidence, including but not limited to mortality. These considerations led them to ask whether it is appropriate to allow the subjective measure of pain to so dominate the clinical decision of whether to proceed with augmentation. The discussions that ensued are related below.

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Minimally invasive interspinous process devices (IPD), including interspinous distraction devices (IDD) and interspinous stabilizers (ISS), are increasingly utilized for treating symptomatic lumbar canal stenosis (LCS). There is ongoing debate around their efficacy and safety over traditional decompression techniques with and without interbody fusion (IF). This study presents a comprehensive review of IPD and investigates if: (I) minimally invasive IDD can effectively substitute direct neural decompression and (II) ISS are appropriate substitutes for fusion after decompression. Articles published up to 22nd January 2020 were obtained from PubMed search. Relevant articles published in the English language were selected and critically reviewed. Observational studies across different IPD brands consistently show significant improvements in clinical outcomes and patient satisfaction at short-term follow-up. Compared to non-operative treatment, mini-open IDD was had significantly greater quality of life and clinical outcome improvements at 2-year follow-up. Compared to open decompression, mini-open IDD had similar clinical outcomes, but associated with higher complications, reoperation risks and costs. Compared to open decompression with concurrent IF, ISS had comparable clinical outcomes with reduced operative time, blood loss, length of stay and adjacent segment mobility. Mini-open IDD had better outcomes over non-operative treatment in mild-moderate LCS at 2-year follow-up, but had similar outcomes with higher risk of re-operations than open decompression. ISS with open decompression may be a suitable alternative to decompression and IF for stable grade 1 spondylolisthesis and central stenosis. To further characterize this procedure, future studies should focus on examining enhanced new generation IPD devices, longer-term follow-up and careful patient selection.

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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.

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No aspect of neurointerventional practice has been associated with as longstanding contention and debate as to its effectiveness as has vertebroplasty (VP). Four blinded randomized controlled trials published since 2009 have demonstrated conflicting results regarding a conferred benefit in pain reduction and functional improvement for patients who undergo VP for osteoporotic vertebral compression fractures. Significant heterogeneity exists between each of these trials, which has resulted in difficulty for interventionalists and surgeons to translate the trial findings into routine clinical practice. In addition, patients and their families are ever more enlightened and enabled via the internet and social media to review both medical literature and websites. Without the proper background and context, their decisions may be lacking appropriate and necessary scientific discussion. This review article summarizes the randomized controlled trial data to date, with particular focus on the aforementioned four blinded studies. We will also evaluate the profound impact of the decrease in vertebral augmentation utilization on short- and long-term patient morbidity and mortality using available national and administrative datasets from both within the USA and internationally. We also consider future trial design to help evaluate this procedure and determine its role in modern neurointerventional practice.

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Low back pain, radicular leg pain, and lumbar spinal stenosis are the most common of all chronic pain disorders. Discogenic pain is related to distress of annular fibers and tears, whereas spinal stenosis is related to reduction of the spinal canal dimensions and compression of the neural elements; radicular pain is mainly related to disc herniation and is initially managed conservatively. The percutaneous minimally invasive approach in discogenic and radicular pain is designed to reduce the volume of the nucleus pulposus in patients with failure of medical and physical treatment prolonged for at least 6 weeks.

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Low back pain is an extremely common pathology affecting a great share of the population, in particular, young adults. Many structures can be responsible for pain such as intervertebral discs, facet joints, nerve roots, and sacroiliac joints. This review paper focuses on disc pathology and the percutaneous procedures available to date for its treatment. For each option, we will assess the indications, technical aspects, advantages, and complications, as well as outcomes reported in the literature and new emerging trends in the field.

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BACKGROUND CONTEXT: Balloon kyphoplasty (BKP) is a commonly performed vertebral augmentation procedure for painful osteoporotic vertebral compression fractures (OVCFs). OBJECTIVE: This study aimed to support a non-inferiority finding for the use of a titanium implantable vertebral augmentation device (TIVAD) compared to BKP. STUDY DESIGN: Prospective, parallel group, controlled comparative randomized study. PATIENT SAMPLE: Patients who presented with one or two painful OVCFs located between T7 and L4 aged <3 months, failed conservative treatment, and had an Oswestry Disability Index (ODI) score ≥30/100 were eligible for the study. OUTCOME MEASURES: The primary composite endpoint was defined as: reduction in VCF fracture-related pain at 12 months from baseline and maintenance or functional improvement (ODI) at 12 months from baseline, and absence of device-related adverse event or surgical reintervention. If the primary composite endpoint was successful, a fourth component (absence of adjacent level fracture) was added for analysis. If the analysis of this additional composite endpoint was successful, then midline target height restoration at 6 and 12 months was assessed. Secondary clinical outcomes included back pain intensity, ODI score, EQ-5D index score (range 0=death to 1=full health) and EQ-VAS score (range 0-100). METHODS: Patients were recruited in 13 hospitals across 5 countries and were randomly assigned (1:1) to either TIVAD or BKP with electronic randomization as described in the protocol. A total of 152 patients with OVCFs were initially randomized. Eleven patients were excluded (six met exclusion criteria, one with evidence of tumor, and four patients had T score out of requested range). Anterior vertebral body height ratio, midline vertebral body height ratio, and Cobb angle were measured preoperatively and postoperatively by an independent imaging core lab. Adjacent and subsequent fractures and safety parameters were recorded throughout the study. Cement extravasation was evaluated on X-rays. All patients were followed at screening at 5 days, 1 month, 6 months, and 12 months postoperatively. This study was supported by Vexim SA. Seven authors received study-specific support less than $10,000 per year and seven authors received no study-specific support. RESULTS: Among the 141 patients (78.7% female, mean age 73.3±9.5 years) who underwent surgery (TIVAD=68; BKP=73), 126 patients (89.4%) completed the 12-month follow-up period (TIVAD=61; BKP=65). The analysis of primary endpoint on the ITT population demonstrated non-inferiority of the TIVAD to BKP. The analysis of the additional composite endpoint demonstrated the superiority of TIVAD over BKP (p<0.0001) at 6 months (88.1% vs. 60.9%) and at 12 months (79.7% vs. 59.3%). Midline VB height restoration was more improved for TIVAD than for BKP at 6 months (1.14±2.61 mm vs. 0.31±2.22 mm); p=0.0246) and 12 months after surgery (1.31±2.58 mm vs. 0.10±2.34 mm; p=0.0035). No statistically significant differences were shown between procedures for improvement in functional capacity and quality of life. Pain relief was significantly more marked in the TIVAD group compared to the BKP group at 1 month (p=0.029) and at 6 months (p=0.021) after surgery. No patient required surgical reintervention or retreatment at the treated level. No symptomatic cement leakage was reported. Adverse events were similar for both groups (41.2% in the TIVAD group and 45.2% in the BKP group). The incidence of adjacent fractures was significantly lower after the TIVAD procedure than after BKP (12.9% vs. 27.3%; p=0.043). CONCLUSIONS: Study results demonstrated non-inferiority of the TIVAD to the predicate BKP with an excellent risk/benefit profile for results up to 12 months.

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A comprehensive description of the literature regarding interspinous process devices (IPD) mainly focused on comparison with conservative treatment and surgical decompression for the treatment of degenerative lumbar spinal stenosis. Recent meta-analysis and articles are listed in the present article in order to establish IPD pros and cons.

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Interventional radiology provides local management of bone metastases (BM) with a palliative intent in most cases, or with a curative intent in selected patients. Its role has rapidly expanded in the last decade, offering new treatment solutions often in combination with surgery, radiation therapy and medical treatments. The aim of the present paper is to increase awareness, acceptance and adoption of interventional radiology procedures for the treatment of BM; and to present the joint position of the Italian College of Musculoskeletal Radiology and the Italian College of Interventional Radiology.

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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.

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Spinal pain is a common condition leading to significant disability and high cost. Spinal injections have been demonstrated to be effective short-term treatments with cost-utility superior to numerous other treatments, including surgical procedures. Appropriate patient selection-based on clinical and imaging finding-and the use of image guidance associated with technical precautions improve the safety and effectiveness of spinal injection and overall patient outcomes.

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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.

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Vertebral compression fractures (VCFs) may result in a kyphotic deformity which can cause potential systemic complications secondary to respiratory and gastrointestinal dysfunction. The use of implants in the spine for VCF treatment represents a paradigm shift away from cement injection on its own, aiming to combine the analgesic and stabilizing effect of injecting cement into the vertebral body with vertebral height restoration and kyphotic angle correction. Spine implants which can be used for VCF treatment include stents, jacks, PEEK cages and fracture reduction systems. Lumbar spinal stenosis (LSS) with neurogenic intermittent claudication is one of the most commonly occurring spinal conditions, usually affecting people older than 50, which can cause disability and a reducted quality of life. Percutaneous interspinous spacers for the relief of symptoms caused by spinal stenosis can be used in patients who are not surgical candidates. The purpose of this article is to describe the basic concepts of spinal implantation in patients with VCF or spinal stenosis. The role of biomechanics and the different types of implants will be described. Controversies concerning techniques and products will be addressed. Finally, the necessity for an individually tailored approach for the use of different implants in different cases and anatomic locations will be emphasized.

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