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Spinal Stenosis clinical trials

View clinical trials related to Spinal Stenosis.

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NCT ID: NCT03048955 Withdrawn - Clinical trials for Spinal Stenosis, Lumbar Region With Neurogenic Claudication

Assessing Superion Clinical Endpoints vs. Decompression

ASCEND
Start date: February 8, 2017
Phase: N/A
Study type: Interventional

PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical Success of the study group receiving the Superion® IDS is not inferior to the success rate observed in the study group treated by direct decompression at 60 months follow-up. Secondarily, the trial is intended to establish that Composite Clinical Success of the study group receiving the Superion® IDS at 24 months is not inferior to the success rate observed at 24 months in patients treated with the Superion® IDS in the original IDE trial. Thirdly, the trial is intended to establish that Composite Clinical Success of the population receiving the Superion® IDS in this trial at 24 months is not inferior to the success rate observed at 24 months in patients treated with direct decompression.

NCT ID: NCT03047044 Completed - Back Pain Clinical Trials

The Comparison of Postoperative Pain After Lumbar Fusion Surgery in Intravenous Patient-controlled Analgesia Between Conventional Mode and Optimizing B.I Mode With 'PAINSTOP' Equipment

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

The postoperative pain of lumbar fusion surgery is very severe that it is necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The most common pain control method of this surgery is the intravenous (IV) PCA. but, if it is relatively insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce the pain intensity effectively. Consequently, it may result in the a lot of rescue analgesics requirement, which leads to the adverse effects in patients who are very sensitive to narcotic analgesics. In addition, the patient's satisfaction to the PCA may be low compared with that of expected. For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a new mode, so that the administered rate and amount of drug can be increased or decreased according to the patient's use of bolus button. Therefore, this PCA device can be implemented to the conventional mode, and added the function of automatically controlling the basal rate and administered amount of drug according to the use demand of the patient. However, since there are few studies related to this new mode of PCA, more research is needed in patients with postoperative pain.

NCT ID: NCT03041896 Completed - Spinal Stenosis Clinical Trials

Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion

Start date: July 2016
Phase:
Study type: Observational

To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2 levels with the coflex® Interlaminar Technology or decompression with or without fusion.

NCT ID: NCT03012776 Completed - Clinical trials for Lumbar Spinal Stenosis

A Pivotal Study of the Premia Spine TOPS™ System

Start date: July 17, 2017
Phase: N/A
Study type: Interventional

The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1) at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint capsule. Success will be assessed by means of a composite endpoint that measures improvement in in patient reported outcomes and the absence of any major device related complications.

NCT ID: NCT03011866 Not yet recruiting - Spinal Stenosis Clinical Trials

Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries

TARGETS
Start date: February 2017
Phase: N/A
Study type: Interventional

Multilevel decompression and bone graft fusion is a most effective measure for treating degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large amount of perioperative blood loss and high demand for homologous blood transfusion. Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in various kinds of surgeries. However, high quality evidence of its efficacy and safety is still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the optimal drug delivery route of TXA remains undetermined. The aim of this study is to test the non-inferiority of topical TXA application to its intravenous use in multilevel decompression and bone graft fusion surgeries. A prospective, randomized, double-blind, head-to-head comparison study design will be adopted.

NCT ID: NCT02982291 Withdrawn - Clinical trials for Spinal Stenosis Lumbar

Focused Spinal Stenosis Rehabilitation Program for Lumbar Spinal Stenosis

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Lumbar spinal stenosis with neurogenic claudication is a common condition in the elderly population and is characterized by bilateral buttock, thigh, or calf discomfort and/or pain, as well as by weakness precipitated by walking and prolonged standing. Self-management options include physical therapy, which includes exercise as a core component for improving the flexibility and mobility of the spine and hips. A Williams flexion protocol has historically been used to treat low-back pain following degenerative changes to the posterior elements of the lumbar spine. However, few studies have been done to validate the efficacy of this protocol. A more focused treatment protocol may be more efficacious. Patients in this study will be randomized to receive either the generic physical therapy protocol (15 sessions) or the focused rehabilitation program (5 sessions). The sessions will take place over the course of 6 months. Outcomes will be assessed using validated questionnaires and physical function tests.

NCT ID: NCT02975011 Terminated - Clinical trials for Lumbar Spinal Stenosis

Effectiveness and Safety of Korean Medicine for Lumbar Stenosis Patients With Sciatica

Start date: March 4, 2017
Phase:
Study type: Observational

A prospective study investigating the effectiveness and safety in lumbar stenosis patients receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, and quality of life

NCT ID: NCT02939482 Completed - Spinal Stenosis Clinical Trials

A Study Comparison of Clinical Outcome After Different Rate of Infusion in Caudal Epidural Steroid Injection

Start date: October 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effects of different rates of Caudal Epidural Steroid Injection (CESI) on clinical outcomes of the patients.

NCT ID: NCT02932020 Withdrawn - Low Back Pain Clinical Trials

AlloGen-LI Treatment of Spinal Stenosis

Start date: October 2016
Phase: N/A
Study type: Interventional

In this pilot study, investigators will test the efficacy of AlloGen-LI, an allograft derived from amniotic fluid, injected into the epidural space at the level of spinal stenosis as an anti-inflammatory treatment to relieve back and leg pain symptoms in patients with spinal stenosis and/or disc herniation. The patients will be followed for 12 weeks. The effect of this treatment will be examined by patient reported changes in pain and disability utilizing validated outcome measures, and MRI imaging evaluating changes in contrast enhancement and T2 signal related to that reflect inflammation and degeneration.

NCT ID: NCT02931279 Completed - Spinal Stenosis Clinical Trials

PASS OCT® Post-market Clinical Follow-up

Start date: October 2016
Phase:
Study type: Observational

Prospective, multicenter non comparative and observational study (post-market clinical follow-up). Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017. The inclusion period will be 12 months and the follow-up 24 months