Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial.

INTRODUCTION Discogenic pain is the cause of pain in 26%-40% of patients with for low back pain. Consensus about treatment of chronic discogenic low back pain is lacking and most treatment alternatives are supported by limited evidence. The percutaneous implantation of hydrogels into the nucleus pulposus represents a promising regenerative intradiscal therapy. The hydrogel 'GelStix' is composed primarily of hydrolyzed polyacrylonitrile and acts as a reservoir of hydration, producing increased pressure and improved pH balance, potentially leading to disc preservation. We hypothesise that treatment with GelStix will lead to greater reduction in pain intensity at 6 months post-treatment compared with patients receiving sham treatment. METHODS AND ANALYSIS This is a parallel group, randomised sham-controlled double-blind, multicentre trial to assess whether the GelStix device is superior to sham in reducing pain intensity in patients with chronic discogenic low back pain. The study will be conducted in two regional hospitals in Europe. Seventy-two participants will be randomised in a 1:1 ratio. The primary outcome will be the change in pain intensity between preoperative baseline and at 6 months postintervention. Secondary outcomes were disability, quality of life, the patient's global impression of change scale, the use of pain medication and the disc degeneration process assessed by means of MRI. For change in pain intensity, disability, health-related quality of life and disc height, mean values will be compared between groups using linear regression analysis, adjusted for treatment centre. ETHICS AND DISSEMINATION Ethics approval was obtained from the Ethics Committee of the Canton Ticino, Switzerland (CE2982) and by the Medical Ethical Committee Arnhem-Nijmegen, the Netherlands (2016-2944). All patients that agree to participate will be asked to sign an informed consent form. Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations. TRIAL REGISTRATION NUMBER NCT02763956. PROTOCOL VERSION 7.1, 18 November 2020

Vertebral Augmentation: Is It Time to Get Past the Pain? A Consensus Statement from the Sardinia Spine and Stroke Congress

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

Mechanical Cavity Creation with Curettage and Vacuum Suction (Q-VAC) in Lytic Vertebral Body Lesions with Posterior Wall Dehiscence and Epidural Mass before Cement Augmentation.

Background and Objectives: We describe a novel technique for percutaneous tumor debulking and cavity creation in patients with extensive lytic lesions of the vertebral body including posterior wall dehiscence prior to vertebral augmentation (VA) procedures. The mechanical cavity is created with a combination of curettage and vacuum suction (Q-VAC). Balloon kyphoplasty and vertebral body stenting are used to treat neoplastic vertebral lesions and might reduce the rate of cement leakage, especially in presence of posterior wall dehiscence. However, these techniques could theoretically lead to increased intravertebral pressure during balloon inflation with possible mobilization of soft tissue tumor through the posterior wall, aggravation of spinal stenosis, and resultant complications. Creation of a void or cavity prior to balloon expansion and/or cement injection would potentially reduce these risks. Materials and Methods: A curette is coaxially inserted in the vertebral body via transpedicular access trocars. The intravertebral neoplastic soft tissue is fragmented by multiple rotational and translational movements. Subsequently, vacuum aspiration is applied via one of two 10 G cannulas that had been introduced directly into the fragmented lesion, while saline is passively flushed via the contralateral cannula, with lavage of the fragmented solid and fluid-necrotic tumor parts. Results: We applied the Q-VAC technique to 35 cases of thoracic and lumbar extreme osteolysis with epidural mass before vertebral body stenting (VBS) cement augmentation. We observed extravertebral cement leakage on postoperative CT in 34% of cases, but with no clinical consequences. No patients experienced periprocedural respiratory problems or new or worsening neurological deficit. Conclusion: The Q-VAC technique, combining mechanical curettage and vacuum suction, is a safe, inexpensive, and reliable method for percutaneous intravertebral tumor debulking and cavitation prior to VA. We propose the Q-VAC technique for cases with extensive neoplastic osteolysis, especially if cortical boundaries of the posterior wall are dehiscent and an epidural soft tissue mass is present

Giant Tumefactive Perivascular Spaces Mimicking a Brain Mass Lesion: Report of Three Cases

Virchow–Robin spaces or perivascular spaces are pial-lined fluid-filled interstitial spaces recognized throughout brain parenchyma along the path of penetrating vessels. Occasionally, they may become enlarged, cause mass effect, and be mistaken for cystic neoplasms or infections. We report three cases of giant tumefactive perivascular spaces (GTPVS) incidentally found at brain magnetic resonance imaging (MRI). The lesions were multilocular cystic-appearing, isointense to cerebrospinal fluid on all pulse sequences, and did not enhance. They were located both in typical and atypical locations and in one case associated with hydrocephalus. We describe the key features of GTPVS on MRI and illustrate the need to acknowledge and promptly recognize these entities in daily practice in order to avoid unnecessary treatment

Ruptured lenticulostriate artery aneurysm: a report of a case treated with endovascular embolisation

A 65-year-old woman presented to the emergency department with sudden onset of left-sided weakness, headache and vomiting. A cerebral CT showed an acute intracerebral haemorrhage involving the right caudate nucleus and lentiform nucleus with mild midline shift and intraventricular extension. CT angiography did not reveal aneurysm or other vascular anomaly. Conventional cerebral angiography demonstrated a 3mm right medial lenticulostriate branch aneurysm, arising from the right anterior cerebral artery (ACA). Endovascular treatment was performed from the left internal carotid via the anterior communicating artery into the right ACA. Complete occlusion was achieved with injection of N-butyl-2-cyanoacrylate. The patient had neurological rehabilitation during hospitalisation followed by outpatient physical therapy. Two years later, clinical follow-up demonstrated excellent recovery

Syrinx reduction due to spontaneous spinal cord tear: demonstration on 3 T MRI and review of the literature.

A holocord syringomyelia due to Chiari 1.5 malformation (CM) in a 12-year-old girl was serially imaged with 3 T MRI over 4 years. The serial MRI showed reduction in size of the syrinx, without any surgical intervention or CM improvement, but rather due to spontaneous spinal cord tear. The tear was clearly demonstrated by evidence of flow signal across the tear between syrinx and subarachnoid space at the upper thoracic level. The tear showed spontaneous closure at follow-up. A medullary tear has been described in the adult population as one of the putative causes of spontaneous syringomyelia reduction, but its clear demonstration with modern high-resolution MRI has not been reported in the paediatric population. Moreover, this is the first reported case of syrinx reduction due to spontaneous fissuration in a paediatric patient

Radiation dose to the operator during fluoroscopically guided spine procedures

Purpose: Fluoroscopy is widely used to guide diagnostic and therapeutic spine procedures. The purpose of this study was to quantify radiation incident on the operator (operator Air Kerma) during a wide range of fluoroscopy-guided spine procedures and its correlation with the amount of radiation incident on the patient (Kerma Area Product\ue2\u80\u94KAP). Methods: We retrospectively included 57 consecutive fluoroscopically guided spine procedures. KAP [Gy\uc2\ua0cm2] and total fluoroscopy time were recorded for each procedure. An electronic dosimeter recorded the operator Air Kerma [\uce\ubcGy] for each procedure. Operator Air Kerma for each procedure, correlation between KAP and operator Air Kerma, and between KAP and fluoroscopy time was obtained. Results: Operator Air Kerma was widely variable across procedures, with median value of 6.4\uc2\ua0\uce\ubcGy per procedure. Median fluoroscopy time and median KAP per procedure were 2.6\uc2\ua0min and 4.7\uc2\ua0Gy\uc2\ua0cm2, respectively. There was correlation between operator Air Kerma and KAP (r2\uc2\ua0=\uc2\ua00.60), with a slope of 1.6\uc2\ua0\uce\ubcGy Air Kerma per unit Gy\uc2\ua0cm2KAP incident on the patient and between fluoroscopy time and KAP (r2\uc2\ua0=\uc2\ua00.63). Conclusion: Operator Air Kerma during individual fluoroscopy-guided spine procedures can be approximated from the commonly and readily available information of the total amount of radiation incident on the patient, measured as KAP