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Spinal Injuries clinical trials

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NCT ID: NCT05883618 Recruiting - Trauma Clinical Trials

Global Neurotrauma Outcomes Study: Spine

GNOS Spine
Start date: July 12, 2021
Phase:
Study type: Observational

Primary aim: Characterise case-mix, processes of care and variations in nonoperative and operative management strategies, including emergency, ward, surgical and ICU care, in patients presenting with traumatic spinal injury (TSI) between centres across low and high Human Development Index (HDI) countries. Primary outcome measure: The primary outcome measure will be Frankel Grade at 6 weeks post-admission (or discharge, whichever comes first). Primary comparison: Between country groups defined by human development index Centre eligibility: Any unit assessing patients with TSI worldwide will be eligible to participate Patient eligibility: All adult patients presenting with radiologically confirmed traumatic spinal injury. Team: Each participating unit will form a study team of up to four investigators including a study lead, local investigator 1/2 and an independent data validator. Time period: Local study teams may select any 30-day period from July 12th 2021 to start their study. Patients who meet the inclusion criteria between 00:01 on day 0 and 23:59 on day 30 of the selected study period will be included. Validation: There will be a two-phase data validation process. Phase 1 will be prospective, validating case ascertainment, and phase 2 will be retrospective, validating operative data.

NCT ID: NCT05597176 Recruiting - Spinal Injuries Clinical Trials

Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury

TEAM-SCI
Start date: January 13, 2023
Phase: N/A
Study type: Interventional

The purpose of this research is to test the health benefits of using functional electrical stimulation for lower extremity exercise at home.

NCT ID: NCT05530798 Recruiting - Clinical trials for Spinal Cord Injuries

CEUS For Intraoperative Spinal Cord Injury

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Spinal cord injury following posterior decompression in patients suffering from chronic, cervicothoracic spinal cord compression is a known complication with multiple etiologies. Currently, intraoperative neuromonitoring (IONM) remains the gold standard for predicting and preventing post-operative deficits from these procedures. However, there is a paucity in the field of spine surgery for further, non-invasive biomarkers that can help detect and prognosticate the degree of spinal cord injury intraoperatively. Contrast enhanced ultrasound (CEUS) is a radiation free imaging modality that utilizes nanobubble technology to allow for visualization of the macro- and microvascular architecture of soft tissue structures. Despite being currently approved for the use in hepatology and cardiology, it has remained absent from the field of spinal cord injury. The study team aims to evaluate and quantify micro- and macrovascular changes that lead to areas of hyper-perfusion as well as areas of ischemia intraoperatively in patients that undergo elective cervicothoracic posterior decompression for chronic compression. In addition, the study team aims to assess the efficacy of CEUS in detecting microvascular changes that correlate with IONM changes and predicting degree and recovery of post-operative neurologic deficits from intraoperative spinal cord injury. The study team hypothesizes that following decompression, subjects will have detectable levels of microvascular changes causing areas of hypoperfusion and reperfusion injury. Second, the study team hypothesizes that these perfusion changes will correlate with intraoperative neuromonitoring changes and can predict and prognosticate the degree of post-operative neurologic injury.

NCT ID: NCT05262140 Recruiting - Spine Injury Clinical Trials

In Vivo Quantification of Cervical Collar Efficacy

Start date: January 19, 2022
Phase:
Study type: Observational

This is a prospective interventional trial with healthy volunteers at Methodist Dallas Medical Center. We anticipate data collection to be completed by December 2023. All study participants will be consented regardless of their role as healthy C-spine volunteer or provider volunteer (Appendix C). No compensation will be provided. Provider volunteers will be classified as: - Attending - Resident - Physician assistant, nurse practitioner, or nurse - EMS/Paramedic - Other, as determined by job functions in pre-assessment

NCT ID: NCT05049330 Recruiting - Clinical trials for Cervical Spine Injury

Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool

C-Spine
Start date: December 12, 2018
Phase:
Study type: Observational [Patient Registry]

Cervical spine injuries (CSI) are serious, but rare events in children. Spinal precautions (rigid cervical collar and immobilization on a longboard) in the prehospital setting may be beneficial for children with CSI, but are poorly studied. In contrast, spinal precautions for pediatric trauma patients without CSI are common and may be associated with harm. Spinal precautions result in well-documented adverse physical and physiological sequelae. Of substantial concern is that the mere presence of prehospital spinal precautions may lead to a cascade of events that results in the increased use of inappropriate radiographic testing in the emergency department (ED) to evaluate children for CSI and thus an unnecessary, increased exposure to ionizing radiation and lifetime risk of cancer. Most children who receive spinal precautions and/or are imaged for potential CSI, and particularly those imaged with computed tomography (CT), are exposed to potential harm with no demonstrable benefit. Therefore, there is an urgent need to develop a Pediatric CSI Risk Assessment Tool that can be used in the prehospital and ED settings to reduce the number of children who receive prehospital spinal precautions inappropriately and are imaged unnecessarily while identifying all children who are truly at risk for CSI.

NCT ID: NCT04937868 Recruiting - Aortic Dissection Clinical Trials

Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients

NEXUS AP CT
Start date: January 15, 2018
Phase:
Study type: Observational

Unrecognized abdominal and pelvic injuries can result in catastrophic disability and death. Sporadic reports of "occult" injuries have generated concern, and physicians, fearing that they may miss such an injury, have adopted the practice of obtaining computed tomography on virtually all patients with significant blunt trauma. This practice exposes large numbers patients to dangerous radiation at considerable expense, while detecting injuries in a small minority of cases. Existing data suggest that a limited number of criteria can reliably identify blunt injury victims who have "no risk" of abdominal or pelvic injuries, and hence no need for computed tomography (CT), without misidentifying any injured patient. It is estimated that nationwide implementation of such criteria could result in an annual reduction in radiographic charges of $75 million, and a significant decrease in radiation exposure and radiation induced malignancies. This study seeks to determine whether "low risk" criteria can reliably identify patients who have sustained significant abdominal or pelvic injuries and safely decrease CT imaging of blunt trauma patients. This goal will be accomplished in the following manner: All blunt trauma victims undergoing computed tomography of the abdomen/pelvis in the emergency department will undergo routine clinical evaluations prior to radiographic imaging. Based on these examinations, the presence or absence of specific clinical findings (i.e. abdominal/pelvic/flank pain, abdominal/pelvic/flank tenderness, bruising abrasions, distention, hip pain, hematuria, hypotension, tachycardia, low or falling hematocrit, intoxication, altered sensorium, distracting injury, positive FAST imaging, dangerous mechanism, abnormal x-ray imaging) will be recorded for each patient, as will the presence or absence of abdominal or pelvic injuries. The clinical findings will serve as potential imaging criteria. At the completion of the derivation portion of the study the criteria will be examined to find a subset that predicts injury with high sensitivity, while simultaneously excluding injury, and hence the need for imaging, in the remaining patients. These criteria will then be confirmed in a separate validation phase of the study. The criteria will be considered to be reliable if the lower statistical confidence limit for the measured sensitivity exceeds 98.0%. Potential reductions in CT imaging will be estimated by determining the proportion of "low-risk" patients that do not have significant abdominal or pelvic injuries.

NCT ID: NCT04550117 Recruiting - Clinical trials for Spinal Cord Injuries

Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury: A Validation Study

Start date: June 23, 2020
Phase: N/A
Study type: Interventional

Intraspinal pressure monitoring has been advanced as a potential technique for evaluating spinal cord perfusion after traumatic spinal cord injury. In this study, the investigators aim to validate the technique for insertion of a fiberoptic pressure monitoring device in the subarachnoid space at the site of injury for measurement of intraspinal pressure and spinal cord perfusion pressure. The primary objective of this study is to validate the methodology of invasive intraspinal pressure monitoring to derive parameters for optimal spinal cord perfusion pressure, spinal cord reserve capacity and spinal reactivity index using data obtained during the patient's stay in the intensive care unit. Secondary objectives of this study will be to a) evaluate the safety of invasive intraspinal pressure monitoring, b) prospectively evaluate the overall relationship between spinal cord perfusion pressure and functional outcomes in patients with acute traumatic spinal cord injury and c) evaluate the relationship between spinal cord perfusion pressure, motor evoked potentials and functional outcomes after incomplete spinal cord injury.

NCT ID: NCT04530955 Recruiting - Clinical trials for Traumatic Brain Injury

Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)

Start date: September 24, 2020
Phase: N/A
Study type: Interventional

Comparing the efficacy of Intracthecal Baclofen dose between the Prometra II and Medtronic SynchroMed II for patients with spasticity and with current a current SyncroMed II pump needing replacement.

NCT ID: NCT04460872 Recruiting - Clinical trials for Spinal Cord Injuries

Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury

Start date: January 31, 2021
Phase: Phase 2
Study type: Interventional

This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.

NCT ID: NCT04396613 Recruiting - Spinal Injuries Clinical Trials

Wound Closure Techniques in Primary Spine Surgery

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The Researchers are trying to determine if there is a difference in blood flow around a wound site when comparing three different types of wound closure techniques.