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Spine Fusion clinical trials

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NCT ID: NCT06082245 Completed - Analgesia Clinical Trials

TLIP Block and ESP Block For Perioperative Analgesia In Patients With Lumbar Spine Fusion Surgery

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Background: Pain relief for lumbar spine surgery is being updated to help improve the quality of post-operative recovery, especially ultrasound-guided pain relief anesthesia methods, including two anesthesia methods. Thoracolumbar interfascial plane block (TLIP block) and erector spinae plane block (ESP block) are increasingly commonly applied. Objective: compare the pain relief effectiveness of TLIP block with ESP block for lumbar spine surgery. Methods: Randomized prospective intervention study conducted at Hanoi Medical University Hospital from October 2021 to October 2022 including 100 lumbar spine surgery patients randomly divided into three groups: group control, TLIP group and ESP group. Outcomes regarding perioperative pain score (ANIm, VAS), the effectiveness of 2 ultrasound-guided methods, the complications and the side effects were recorded.

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: NCT04711668 Completed - Postoperative Pain Clinical Trials

Effect of Introperative Ketamine and Lidocaine Infusion on Postoperative Opioid Consumption in Posterior Spinal Fusion Surgery

Start date: May 29, 2019
Phase: N/A
Study type: Interventional

Objective: The primary aim of this study was to investigate the effect of ketamine and lidocaine on postoperative opioid consumption in posterior spinal fusion surgery. Materials and Methods: Ethics committee approval was received from our faculty. Seventy-five cases between the ages of 18-65, who have an ASA (American Society of Anesthesiologists) risk classification I-II-III in the preanesthetic evaluation, planned to be operated by the Neurosurgery clinic for lumbar posterior spinal fusion surgery under elective conditions have been included in the study after the informed volunteer consent form was read and approved. The patients were randomly divided into 3 groups using the closed envelope method. The ketamine group (Group K) (n = 25), the lidocaine group (Group L) (n = 25) and the placebo group (Group P) (n = 25). Propofol, rocuronium and fentanyl i.v. done. In group K, 0.5 mg / kg i.v. ketamine bolus and 0.25 mg / kg / hr i.v. ketamine infusion was administered. In group L, 1.5 mg / kg i.v. lidocaine bolus and 1.5 mg / kg / hr i.v. lidocaine infusion was administered. In group P, i.v. saline (in the same volume and duration) was applied. Maintenance of anesthesia was provided by propofol and remifentanil infusion. The propofol and remifentanil doses were adjusted according to the BIS monitoring and the increase or decrease in basal blood pressure and heart rate values of 20% or more. The BIS value was kept between 40-60. At the end of surgery, infusions were closed. After extubation, the patients were taken to the recovery room. Patient controlled analgesia (PCA) prepared with fentanyl was applied to the patients for postoperative analgesia. The PCA device was attached for 24 hours postoperatively. Postoperative 0-4 hours, 4-8 hours, 8-24 hours and total fentanyl consumption of the patients were evaluated. Pain scores were measured at 1, 2, 4, 8, 12 and 24 hours in the postoperative recovery room. Intraoperative propofol and remifentanil consumption was recorded. Tramadol 1 mg / kg i.v. as rescue analgesia (in patients with VAS pain score of 4 and above) done. Possible side effects due to opioid, ketamine and lidocaine were followed.

NCT ID: NCT04682418 Completed - Spine Fusion Clinical Trials

Pedicle Screw Placement With XVS

Start date: May 20, 2018
Phase: N/A
Study type: Interventional

Open label, prospective, single arm, multi-center study. Pedicle screws placement in sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2) different surgeons, using the XVISION SPINE system. Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists, using the Gertzbein score. Subjects will undergo intraoperative 3D scan prior to screws placement to enable 3D model rendering and XVISION SPINE system registration. Subjects will undergo intraoperative 3D scan post procedure to enable offline scoring of pedicle screw placement using the Gertzbein score. Surgeons performing the procedures will be requested to fill in usability questionnaires at the end of the procedure

NCT ID: NCT04679896 Completed - Clinical trials for Degenerative Disc Disease

Post Marketing Study of MagnetOs Putty Compared to Local Autograft in Patients Undergoing Posterolateral Lumbar Fusion

PARTNER
Start date: August 13, 2021
Phase: N/A
Study type: Interventional

This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with leg pain and/or back pain and undergoing spinal fusion surgery. In this study, MagnetOs Putty 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.

NCT ID: NCT04545983 Completed - Spinal Stenosis Clinical Trials

Long-term Follow-up Motion Analysis of ACD Versus ACDA

Start date: February 12, 2022
Phase: N/A
Study type: Interventional

Rationale: Cervical degenerative disc disease (CDDD) is a common cause of cervical radiculopathy, myelopathy or myeloradiculopathy. Surgical treatment is indicated when conservative therapies do not provide sufficient relief or when neurological complaints are progressive. The main surgical techniques are anterior cervical discectomy with (ACDF) or without fusion (ACD), whereas both techniques result in high fusion rates. Short term outcomes of surgery show good clinical results. Long term follow-up shows a drop-in satisfaction rates, often due to the occurrence of new complaints. Pathology is often located at levels adjacent to the previously operated segment, known as adjacent segment disease (ASDis). This is thought to be the results of loss of motion at the previously operated and fused segment. Anterior cervical discectomy with arthroplasty (ACDA) is developed in an effort to reduce the incidence of ASDis by preserving physiological motion in the operated segment. Objective: To investigate physiological motion of the cervical spine the investigators will analyze motion patterns at the long-term in patients who underwent surgical treatment for CDDD, either ACD or ACDA. Study design: Fundamental research. This is a prospective study that includes a cohort of patients previously operated in the setting of a randomized controlled trial. Study population: Adult patients with an indication of surgical treatment for cervical radiculopathy as a consequence of CDDD were enrolled in an RCT between 2007 and 2014 and assigned to undergo ACD or ACDA. Flexion and extension cinematographic recordings of the cervical spine were performed, with the last one at one-year follow-up. The majority of patients in the ACDA group (80%) showed a normal sequence of segmental contribution, which was not the case in the ACD group. This cohort will now be asked to participate in the long-term follow-up study assessing the motion patterns 6-13 years after ACD or ACDA surgery. Intervention: One flexion and extension cinematographic recording of the cervical spine and will be made. Main study parameters/endpoints: The sequence of segmental contributions in sagittal rotation during flexion and extension of the cervical spine will be assessed in the long-term follow-up of surgical treatment. Secondary outcomes will be to assess the amount of degeneration based on the Kellgren Score (KS) and the segmental range of motion (sROM). Long term clinical outcomes will be assessed according to VAS, NDI, SF-36 and Odom's criteria. Patients will be asked whether they have new neurological symptoms and whether they have had a re-operation. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants receive cinematographic recordings once. The amount of radiation is a negligible risk. There will be no health benefits. There will be no follow-up.

NCT ID: NCT03476811 Completed - Surgery Clinical Trials

Postoperative subQ Pain Control for Spinal Fusion Surgery

Start date: February 9, 2018
Phase: Phase 2
Study type: Interventional

Post-operative pain following lumbar spine fusion is frequently difficult to manage and can lead to increased doses of opiate pain medications to control pain. In this study, the use of subcutaneous local anesthesia will be studied to determine its efficacy at reducing post-operative pain following spinal fusion surgery.

NCT ID: NCT02611479 Completed - Spine Fusion Clinical Trials

Understanding Non-Response in Spine Fusion Surgery

Start date: April 2015
Phase:
Study type: Observational

To identify patient characteristics associated with non-response after spine fusion surgery for the treatment of degenerative disc disease (DDD).

NCT ID: NCT02280187 Completed - Spine Fusion Clinical Trials

InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study

InductOR
Start date: October 2014
Phase: N/A
Study type: Observational

It is a phase IV, national, multicenter, observational, retrospective study collecting data from patient medical files in French spinal centers. The aim of the study is to describe the real world use of InductOs in Spine fusion in France. Approximately 10 French centers will enroll 400 patients. The retrospective review of records will focus on patients who have undergone a spinal fusion surgery. Patient should be considered for enrollment if he/she has been treated with InductOs between January 1, 2011 and 31st December 2012.