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Spine Fusion clinical trials

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NCT ID: NCT05957822 Recruiting - Prostate Cancer Clinical Trials

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

Start date: February 10, 2024
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT05850468 Not yet recruiting - Opioid Use Clinical Trials

Effectiveness of Combining Erector Spinea Block With Non Opioid Infusions as Opioid Free Anesthesia in Spine Surgeries.

Start date: May 2023
Phase: N/A
Study type: Interventional

opioid free anesthesia consists of combination of pharmacological and non pharmacological modalities that target different pathways of pain mechanism. combining myofascial plane blocks with infusion of adjuvants such as lidocaine or dexmedetomidine can offer equivalent intraoperative hemodynamic stability compared to that of opioid with better pain control postoperatively. this study will investigate the efficacy of combined erector spina block with lidocaine and dexmedetomidine infusion as opioid sparing anesthesia in spine surgeries

NCT ID: NCT05746143 Recruiting - Pain, Postoperative Clinical Trials

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

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

NCT ID: NCT05691062 Not yet recruiting - Spine Fusion Clinical Trials

Titanium vs. PEEK Fusion Devices in 1 Level TLIF

TLIF
Start date: June 1, 2023
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT05415657 Completed - Osteopenia Clinical Trials

Denosumab Effect on Bone Quality and Function After Lumbar Fusion Surgery

Start date: January 12, 2020
Phase: N/A
Study type: Interventional

Degenerative lumbar spinal diseases have become a common health problem and the most frequent indication for spinal surgery in elderly individuals. It mainly contain lumbar spinal stenosis and spondylolisthesis, occurs in most people over 60 years of age, and patients primarily diagnosed with lumbar degenerative disease are more likely to have osteoporosis. Our study was to explore denosumab effect on bone quality and functional status in osteopenia patients with lumbar degenerative diseases after lumbar fusion surgery.

NCT ID: NCT05401526 Completed - Anesthesia Clinical Trials

Fluid Responsiveness in Prone Position

Start date: June 5, 2022
Phase:
Study type: Observational

We are planning to measure hemodynamic parameters (Heart Rate, Mean Arterial Pressure, Stroke Volume Index, Stroke Volume Variation, and Pulse Pressure Variation) and ventilatory parameters at four times (T1, T2,T3, and T4) during spinal operation at prone position. First measurement (T1, First baseline) will be performed in the prone position after performing tracheal intubation and confirming hemodynamic stability (defined as mean arterial pressure <10% for 3 minutes). After the T1 measurement, additional 5 cmH2O PEEP (Positive end-expiratory pressure) will be applied for 30 seconds which will be called as "short term low PEEP challenge (SLPC)". At the end of the SLPC and prior to PEEP lowering, T2 measurement will be performed and recorded. After the T2 measurement, PEEP will be decreased to the initial value (5 cmH2O) and three minutes later, a second baseline (T3) measurement will be performed. Thereafter, 500 ml isotonic saline will be loaded in 10 minutes. T4 measurement will be performed again three minutes after volume loading. All of the measurements will be completed before surgery start and surgical stimulus. Patients exhibiting an increase in stroke volume index more than 15% after fluid loading (between T3 and T4) will be classified as volume responders. Absolute pulse pressure variation change due to SLPC, Absolute Stroke volume variation change due to SLPC, stroke volume index percentage change due to SLPC, and stroke volume index percentage change after fluid loading will be calculated and compared. Our aim is to observe if short term low PEEP challenge has the ability to predict fluid responsiveness better than pulse pressure variation and stroke volume variation for patients operated in prone position.

NCT ID: NCT05367609 Recruiting - Spine Fusion Clinical Trials

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

PPAP Spine
Start date: September 20, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05037968 Not yet recruiting - Clinical trials for Degenerative Disc Disease

MagnetOs Flex Matrix Compared to Cell Based Allografts in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

PRECISE
Start date: June 2024
Phase: N/A
Study type: Interventional

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. A cellular based allograft will also be used according to its latest IFU approved in the US. Specifically, the cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.

NCT ID: NCT05001893 Active, not recruiting - Spinal Deformity Clinical Trials

Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery

Start date: May 3, 2021
Phase:
Study type: Observational [Patient Registry]

A retrospective, single-tertiary centre observational study. The study population consists mainly of patients with instrumented posterolateral spine fusion operated at the Department of Neurosurgery or at the Department of Orthopaedics and Traumatology in the Turku University Hospital. Also, patients with non-instrumented posterolateral spine fusion, interbody spine fusion, and a combination of posterolateral and interbody spine fusion are included. The approximate number of the above-mentioned operations with BonAlive® putty is 400 - 500 between September 2013 and April 2021. In the operations, the BonAlive® putty was used either alone, together with autologous bone (AB) chips, with milled allogenous bone chips, with demineralized bone matrix (DBM), with other synthetic bone grafts, or with a combination of the above-mentioned.

NCT ID: NCT04964219 Recruiting - Clinical trials for Postoperative Analgesia

Analgesic Effects of Low-dose S-ketamine in Major Spine Fusion Surgery

Start date: February 8, 2022
Phase: Phase 4
Study type: Interventional

Despite opioid-based multimodal analgesia, moderate-to-severe pain remains a big problem in patients following multi-segment spinal fusion. As a N-methyl-D-aspartate receptor antagonist, S-ketamine has prominent analgesic effects through activating receptors both in the brain and in the spinal cord, inhibiting the excitatory postsynaptic potential, and thus blunting nociception transmission. This randomized controlled trial is designed to investigate whether perioperative S-ketamine infusion can decrease pain intensity after major spine fusion surgery.