Clinical Research Directory

Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion

This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery. In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.

MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery. In this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine. Trinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.

Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery

This study is a randomized controlled trial that will evaluate the effect of non-invasive auricular vagal nerve stimulation on inflammatory markers, glycemic control, postoperative pain, and inflammation-related clinical outcomes after long-segment spinal fusion surgeries when compared to current accepted management.

Rate of Bone Union After Surgery With Stand-alone Fibergraft

Some people have back problems caused by degenerative conditions or instability of the spine (eg. Spondylolisthesis). These problems can lead to pain, nerve issues, or difficulties in walking. A common treatment is a type of back surgery called lumbar interbody fusion, which helps stabilize the spine. At the St. Maartenskliniek in the Netherlands, doctors have been using a special material called Fibergraft Bioactive Glass Putty for such surgeries since 2023. This material helps bones grow and heal, and it's placed inside the spine without needing extra bone from another part of the body. This study will look at how well this material works by evaluating how many patients' bones successfully healed after surgery using this material. It will also look at how patients feel and recover after the procedure

Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)

The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in children undergoing painful surgery.

Ostene in Thoracolumbar Decompression and Fusion Evaluated With VIBE

In spine surgery, it is important to try to minimize bleeding. In particular, spine surgery often involves inserting hardware into bone, and/or removing bone in the spine. Because the bone in the spine contains blood vessels, there can often be bleeding from the bone itself that is difficult to stop completely. One way to stop bone bleeding is through the use of wax-like materials, which plug the bleeding bone and act as a physical barrier to stop bleeding. One example is Ostene bone hemostasis material, which has the advantage of being "water soluble", meaning it will dissolve naturally over time. The purpose of this study is to evaluate how well Ostene does at decreasing bleeding, by using a recognized scale called the validated intraoperative bleeding severity scale, abbreviated as "VIBe". In this study, the investigators will record the bleeding severity throughout multiple time points in surgery using this scale, and then the investigators will compare the measurements to patients in the past who did not receive Ostene. Overall, this research will help measure how well Ostene decreases bleeding.

Effect of Magnesium on Neuromonitoring

Intraoperative neurophysiologic monitoring (IONM) is commonly used during complex spinal surgery to monitor the integrity of neural structures and improve the perioperative safety profile. Transcranial Motor Evoked Potentials (TcMEPs) monitor the integrity of the motor pathways and are one of the most commonly used monitoring modalities in spinal surgery. Because inhaled anesthetics can negatively affect the ability to monitor TcMEPs, anesthesiologists commonly use a combination of propofol and opioids to maintain the anesthetic state. Additionally, anesthesiologists will frequently administer intravenous infusions of medications that can decrease postoperative pain and opioid use (called opioid-sparing adjuncts) because spinal surgeries result in significant postoperative pain. Despite the increasing use of these agents, there is scant clinical data about how they may affect the integrity of TcMEP monitoring. Magnesium (Mg), a N-methyl-d-aspartate receptors (NMDA) receptor antagonist, is one of the adjuncts with robust data supporting clinical efficacy to decrease pain and opioid use on TcMEPs. Mg has been used clinically for decades. The investigators commonly utilize intravenous magnesium as a component of our spinal anesthesia protocol. However, there is only a single case report that discusses the effects of Mg on TcMEPs. Here the investigators propose a prospective clinical trial to quantitatively assess the effects of various Mg plasma levels on TcMEPs. There is a lack of literature on the pharmacokinetics of magnesium in non-pregnant patients.

Titanium vs. PEEK Fusion Devices in 1 Level TLIF

The objective of this study is to evaluate and follow the clinical and radiographic outcomes of patients undergoing 1 level TLIF randomized to either a titanium or a PEEK spacer to 24 months after surgery.

Effect of Ketamine on Intraoperative Motor Evoked Potentials

The goal of this clinical trial is to learn about the effect of ketamine on intraoperative motor evoked potentials in adult patients undergoing thoracolumbar spinal fusions. Participants will undergo a standard anesthetic. In addition to the standard anesthetic, the patients will be administered increasing doses of ketamine with motor-evoked potentials being measured at each dose, to assess any impacts.

Spine Surgery Video Observation Study. The Creation of a Benchmark Video (RGB-Depth) Dataset to Investigate the Feasibility of Developing a Markerless Tracking System for Spine Surgery.

The primary study objective is to build a video dataset, consisting of both colour and depth information, of spine surgery that includes both 'open' and 'minimally invasive' (MIS) surgeries. Using accompanying preoperative CT scans of the patient's spine, we aim to develop a markerless tracking system for spine surgery, which the collected dataset will be used to both train, and then benchmark against.

Pain Control After Lumbar Spine Fusion

The purpose of this randomized controlled trial is to determine if patients who receive non-steroidal anti-inflammatory medications (NSAIDs) following elective lumbar spinal fusion have increased rates of symptomatic nonunion requiring revision spinal surgery at two-years follow-up, compared to those who do not receive NSAIDs.

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

The purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes following surgery.

Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery

The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.

Steroids After Spine Fusion Surgery

This trial studies how well low-dose postoperative corticosteroids (FDA approved) affect patient outcomes (patient reported outcomes, pain medication use, length of stay, major complications, and time to first bowel movement) after thoracic and/or lumbar spine fusion surgery.