Clariance ErYs Registry
Spine DegenerationSpine Spondylosis Thoracic3 moreInternational, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF). The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting. The primary objective is to demonstrate that the use of the study devices is safe. The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.
Validation of Pre-clinical Nano-Based Analgesics in Cells From Human Dorsal Root Ganglia
Spinal Cord NeoplasmThis study investigates the pre-clinical nano-based analgesics in cells from human dorsal root ganglia (clusters of neurons). Collecting these neurons may help future research related to safe and effective pain treatment.
Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumors...
Metastasis Spinal TumorMassive blood loss occurs in metastatic spinal tumor resection and may cause severe complications. The objective of this study is to investigate whether the use of tranexamic acid will reduce perioperative and postoperative bleeding when compared to those without use of tranexamic acid.
Duke Spine Outcome Study (DSOS)
Spinal TumorSpinal DisorderThe primary goal of this registry is to increase the knowledge about spine tumors and other spine disorders to guide appropriate management strategies for the future. This registry will include the review of medical records, data collection for health related quality of life questionnaires, and collected tissues and samples. The study will require obtaining spinal lesions (tumor, etc.), blood, and bone marrow samples (from non-lesional bone) from selected patients, which will be collected during your surgery.
Microsurgical Resection of Intramedullary Spinal Cord Metastases
Spinal Cord MetastasisSpinal Cord Tumor Malignant Intramedullary3 moreThe aim of the study is to establish a multi-center, retrospective database for patients with intramedullary spinal cord metastases (ISCM) and analyse the functional outcome in surgically treated ISCM patients. The hypothesis is that the surgical treatment of selected ISCM patients does not lead to persistent morbidity and does not increase mortality, compared to patients that are treated non-operatively. Secondary objectives are to assess pre- to postoperative neurological deficits, ambulatory status, and overall survival of surgically treated ISCM patients. The investigators intend to include a control cohort of patients with ISCM from participating centers, who underwent non-surgical oncological treatment (radiotherapy with or without chemotherapy). This control cohort of patients will be used to match patients with and without surgical treatment. Primary endpoint (analysed in surgically treated ISCM patients): Functional outcome at 90 days after treatment initiation, measured by the modified Japanese Orthopaedic Association (mJOA) scale. This is a score evaluating motor function of upper and lower extremities, sensory function of upper extremities and sphincter function / voidance. The mJOA ranges from 0 - 18 points, with higher score values representing better functional outcome. The minimum clinically important difference of the mJOA is 1-2 points, and scores lower than 14 indicate moderate myelopathy, scores lower than 11 indicate severe myelopathy. Secondary endpoints (analysed in surgically treated ISCM patients and analysed in matched patients with and without surgical treatment): Functional outcome (mJOA) at 6 and 12 months Ambulatory status and continence at 90 days, 6 & 12 months (determined by mJOA subscores) Neurological outcome, measured by American Spinal Cord Injury Association (ASIA) Impairment Scale at 90 days, 6 and 12 months Rate & type of complications at 90 days after treatment according to The Novel Therapy Disability-Neurology Grade (TDN grade)16 Overall survival (in days)
FDG PET-MRI for the Diagnosis of Spinal Cord Lesions
Spinal Cord NeoplasmTo compare the results and understand the possible benefits from FDG-PET/MRI during different scanning time points after FDG, a type of contrast drug, is given.
Chemical Shift Encoding-based Water-fat Magnetic Resonance Imaging in Spinal Tumors
Spinal TumorBone TumorFat composition of the spinal tumors is positively correlated with classification and differential diagnosis of benign and malignant tumors.
3T MRI of Intramedullary Spinal Cord Tumours
Spinal Cord Tumor of Cervical SpineIntramedullary spinal cord tumours (IMSCTs) are a type of tumour that arises from cells within the spinal cord. They are rare, accounting for around 4-10% of central nervous system tumours. They commonly present as back/neck pain and have poor outcomes if not treated. IMSCTs fall into various subtypes. Around 90% are either ependymomas or astrocytomas. Ependymomas are usually quite distinct from the surrounding tissue and therefore can often be treated successfully with surgery. In contrast, astrocytomas tend to invade the surrounding tissue and, as a result, generally cannot be entirely surgically removed. Radiotherapy is recommended instead of surgery for tumours that cannot be operated. Unfortunately, ependymomas and astrocytomas can appear very similar on diagnostic scans and are therefore difficult to tell apart before surgery. Biopsy therefore remains the current gold standard for tumour subtype differentiation. Any spinal cord surgery, whether it be biopsy or resection, poses major challenges due to the small size of the spinal cord. A small corridor via the back of the spinal cord, known as the posterior midline, usually offers the safest approach to a tumour. However, finding this access corridor can be very difficult because tumours tend to deform the anatomy of the spinal cord, leading to a high risk of injury to the normal spinal cord tissue or nerves. The primary objective of this pilot study is to test if cutting-edge spinal cord magnetic resonance imaging (MRI) techniques could help to better differentiate between tumour subtypes. The investigators will do this by comparing various imaging metrics between the tumour subtypes, confirmed by biopsy. The investigators' second objective is to see if these MRI techniques could help to identify, pre-surgery, the location of the posterior midline of the spinal cord. The investigators will do this by comparing the prediction of the midline location from imaging with blinded observations by the surgeon during planned surgery. Additionally, the investigators want to investigate the relationship between imaging metrics and patient pain and sensorimotor symptoms, to explore if imaging offers insight into the variety of clinical symptoms associated with these tumours. The investigators' hope is that the results of this study could inform a future larger trial that would be designed to fully assess the utility of cutting-edge MRI techniques for reducing both the need for spinal cord surgery and the risks associated with surgery in IMSCT patients.
Medical Marijuana in the Pediatric Central Nervous System Tumor Population
Central Nervous System TumorBrain Tumor1 moreThis study proposes to do a prospective observational cohort study evaluating the quality of life (QOL) of children with Central Nervous System (CNS) tumors and their families who choose to self-medicate with marijuana-derived products while undergoing treatment at Children's Hospital Colorado (CHCO).
PMCF Neo Pedicle Screw and Cage Systems
Degenerative Disc DiseaseSpondylolisthesis4 moreThe objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device. To demonstrate non-inferiority of safety and function to an historical control from the published medical literature on competitive devices.