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Spinal Stenosis clinical trials

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NCT ID: NCT06447194 Not yet recruiting - Clinical trials for Degenerative Disc Disease

Effect of RECK in Posterior Spinal Fusion

Start date: April 1, 2025
Phase: Phase 1/Phase 2
Study type: Interventional

"RECK" is a combination of local anesthesia medications, used for the purpose of pain control. RECK is an acronym which stands for Ropivacaine, Epinephrine, Clonidine, and Ketorolac. The purpose of this study is to investigate the effect of RECK local injectable anesthetic in the setting of posterior spinal fusion. Our specific aims are the following. Primary aim: to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores. Secondary aims: to investigate of effect of RECK injection on postoperative opioid consumption and hospital length of stay. Hypothesis: RECK injection will significantly decrease postoperative VAS pain score, opioid consumption, and hospital length of stay compared to placebo controls.

NCT ID: NCT06381167 Not yet recruiting - Clinical trials for Lumbar Spinal Stenosis

Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis

Start date: May 2024
Phase: N/A
Study type: Interventional

To compare between the clinical and surgical efficacies of bi-portal endoscopic and microscopic decompressive laminectomy in patients with degenerative lumbar spinal stenosis.

NCT ID: NCT06367855 Not yet recruiting - Surgery Clinical Trials

Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF : Double Blinded, Randomized Control Trial

MIS-TLIF
Start date: May 1, 2024
Phase: Phase 4
Study type: Interventional

Researchers are considering Dexamethasone as preemptive medication before minimally invasive spine fusion surgery to minimize postoperative back pain with minimal side effects, aiming to enhance the effectiveness of surgery and improve patient outcomes.

NCT ID: NCT06320899 Not yet recruiting - Clinical trials for Degenerative Spondylolisthesis

Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases

Start date: April 2, 2024
Phase: N/A
Study type: Interventional

The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results. The primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods.

NCT ID: NCT06178939 Not yet recruiting - Lung Neoplasms Clinical Trials

Effects of Cognitive Intervention Therapy on Postoperative Delirium

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

This study is a prospective, single-center, randomized controlled trial to compare whether applying cognitive intervention therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium compared to conservative treatment.

NCT ID: NCT06106061 Not yet recruiting - Clinical trials for Degenerative Lumbar Spinal Stenosis

Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis

FFX® RCT
Start date: November 2023
Phase: N/A
Study type: Interventional

This is a prospective, multicentric, comparative, randomised-controlled study to evaluate the safety and efficacy of the Facet Fixation implant. The main objective is to evaluate the effectiveness of spinal decompression associated with FFX® implants compared to spinal decompression alone in treating lumbar spinal stenosis after 2 years of treatment.

NCT ID: NCT06101108 Not yet recruiting - Clinical trials for Transthyretin Amyloid Cardiomyopathy

Early Diagnosis of Age-Linked CArdiac TransThyRetin Amyloidosis by Selective Screening in Spinal Stenosis Surgery

ALCATTRASS
Start date: June 1, 2024
Phase:
Study type: Observational

The goal of this observational study is to keep track of the cardiological follow-up of patients who have undergone back surgery because of symptomatic narrowing of the spinal canal and in whom microscopic examination of the tissue removed during this surgery showed a high amount of local deposits of small proteins. This finding may be an early sign of a condition in which other organs (especially the heart) may also be affected by these proteins, called amyloidosis. Patients who participate in this study, will be followed up for life. During the first routine consultation with the cardiologist, the physician-investigator will collect information, such as demographics (age, weight, height, gender), medical history, medication, symptoms and the results of prescribed examinations. These examinations include microscopic examination of tissue removed during the surgery, blood tests, electrocardiography, echocardiography and a bone scan. These examinations are clinically necessary and appropriate, and patients should undergo them even without participating in the study.

NCT ID: NCT06092138 Not yet recruiting - Clinical trials for Cervical Disc Herniation

Edge Computing Platform for Spine Health Risk Management Based on IoT Technology

Start date: October 30, 2023
Phase: N/A
Study type: Interventional

This project proposes to monitor the spinal posture of a person at rest and in motion in real time through a sensor device that contains spinal health monitoring as its core. By calibrating the five core planes on the spine and using AI algorithms to train the model, the relationship between the core plane data and spine health is established.This project will output medical-grade and consumer-grade wearable spine healthcare and monitoring products, establish an interactive platform to connect the wearer, the data terminal and the professional medical team, so that patients can easily get professional health advice and reminders during home healthcare and rehabilitation; and through the collection of spine health data, establish a national spine health database.

NCT ID: NCT06089746 Not yet recruiting - Clinical trials for Lumbar Spinal Stenosis

Lumbosacral Spinal Stenosis - Non-Invasive Postural Therapy for Older Adult Veterans

LSS-NIPT
Start date: February 15, 2024
Phase: N/A
Study type: Interventional

Lumbosacral spinal stenosis (LSS) is a leading cause of limited mobility, reduced independence, and poor health outcomes in older adults, and is very common in older adult Veterans. Several years ago, major research studies indicated that surgery for LSS was more effective than usual (medical) management. Nonetheless, there are many patients for whom surgery is not the ideal therapy. There have been reports that modifications in daily activities including temporary use of a modified rolling walker and changes in sleep positioning may help relieve LSS. The investigators have assembled a VA team to study this carefully. The investigators will recruit a small group of older adult Veterans with LSS to try out this program; the investigators will monitor them closely for relief of their symptoms and improvements in walking. The investigators will, as part of this small study, try to understand potential barriers to use of this therapy. The investigators will interview the Veterans and healthcare providers to identify problems that may arise in trying this therapy. If this small study works, the investigators plan to expand the effort.

NCT ID: NCT06075355 Not yet recruiting - Clinical trials for Lumbar Spinal Stenosis

Can Minimally Invasive Decompression Surgery Restore Sagittal Balance in a Patient Population With Sagittal Imbalance and Lumbar Spinal Stenosis

Start date: June 30, 2024
Phase:
Study type: Observational

From adulthood onwards, the aging process manifests itself in the spine through loss of disc height and kyphotic deformity. As the general population ages, the prevalence of lumbar degenerative diseases and sagittal imbalance increases. Sagittal balance is a physiological alignment resulting from the effective muscular and ligamentary forces that place patients' heads harmoniously in line with their pelvis. Roussouly first classified this alignment by differentiating four types of balance in an asymptomatic population. He established a link between the varieties of sagittal balance of the spine, the sacral slope and the position of the pelvis in space. He went on to explain sagittal imbalance in the aging population suffering from degenerative diseases. One of the most common lumbar degenerative diseases is lumbar spinal canal stenosis. Stenosis of the lumbar spinal canal is frequently associated with sagittal imbalance of the spine. Lumbar canal stenosis causes lumbar pain, leg pain, neurogenic intermittent claudication and bladder and rectal disorders. The severity of clinical symptoms increases linearly with progressive sagittal imbalance [8]. We represent the sagittal imbalance of the spine by a positive sagittal vertical axis (SVA) presented by patients to reduce the pressure exerted by the yellow ligament, which is hypertrophied in degenerative disease . Many have shown that this forward-flexing posture can be improved by simple decompression, and that this deformity corresponds to an analgesic position and not to a structural deformity. Little is known about the factors that influence alignment after lumbar canal decompression and short segment fusion. This study therefore aims to elucidate some of the clinical and radiological factors likely to affect postoperative sagittal balance in patients undergoing simple minimally invasive decompression surgery and short segment fusion (1 or 2 levels).