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Spinal Stenosis clinical trials

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NCT ID: NCT04483297 Terminated - Spinal Stenosis Clinical Trials

First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)

ENHANCE
Start date: November 18, 2020
Phase: Phase 1
Study type: Interventional

The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing decompression and single level instrumented posterolateral lumber autograft fusion surgery.

NCT ID: NCT04007094 Terminated - Clinical trials for Degenerative Disc Disease

Single-Armed Use of ViviGen Cellular Bone Matrix in Patients Undergoing Posterolateral Lumbar Surgery

Start date: February 12, 2019
Phase: N/A
Study type: Interventional

This is a prospective, single-arm post market study of patients to assess fusion in one or multiple continuous levels of the lumbosacral spine (L1-S1) using ViviGen Cellular Bone Matrix. All subjects will be followed out to 24 months for final assessment.

NCT ID: NCT03801356 Terminated - Back Pain Clinical Trials

Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy

Start date: August 23, 2018
Phase: Phase 4
Study type: Interventional

SNRB, as measured by the change in pain and objective functional ability, can solicit crucial information regarding a patient's clinical picture and can predict a patient's outcome post-surgery. By using the walk test as an objective functional assessment, the aim is to better standardize the threshold for a positive response to SNRB. In summary, SNRB, despite utilized frequently in the diagnostic work-up with patients with lumbar radiculopathy, vary widely in their sensitivity and specificity. The reasons, as outlined above, are multifactorial. The proposed study aims to minimize the known limitations of these injections and prospectively define their positive and negative predictive value in a homogenous group of patients undergoing surgery for lumbar foraminal stenosis and radiculopathy. The design will define a threshold of response utilizing both subjective and objective measures and more accurately predict excellent results following surgery.

NCT ID: NCT03748277 Terminated - Clinical trials for Spinal Stenosis Lumbar Canal With Neurogenic Claudication (Diagnosis)

Comparison of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine

Start date: November 15, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the clinical and radiological results of surgical treatment of one-level central stenosis of the lumbar spine using traditional open approach (PLIF) and a minimally invasive procedure (MIS TLIF). According to the hypothesis, we assume that unilateral approach of MIS TLIF allows for adequate bilateral decompression of one-level central stenosis of the lumbar spine. Using MIS TLIF it is possible to perform reliable fixation of a spine segment and the formation of a complete intervertebral bone fusion. The long-term clinical results of surgical treatment with minimally invasive technologies (MIS TLIF) and traditional open approach (PLIF) suspected to be comparable.

NCT ID: NCT03570801 Terminated - Clinical trials for Lumbar Spinal Stenosis

SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion

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

The purpose of the project is to perform an RCT comparing patient satisfaction and outcome with or without the use of an expert panel. The purpose is also to create a registry to compare the effectiveness of decompression alone versus decompression with fusion for patients with degenerative grade I spondylolisthesis and symptomatic lumbar spinal stenosis. Primary analysis will focus on the patients' improvement from baseline patient-reported outcome questionnaires. In addition, the SLIP II registry aims to (i) develop an algorithm which could identify cases in which surgical experts are likely to recommend one treatment (i.e. >80% of experts recommend one form of treatment) and (ii) develop a radiology-based machine learning algorithm that would prospectively classify patients as either 'stable' or 'unstable.' In addition to patient reported outcomes, step counts will be collected in order to determine the correlation of step count with patient-reported outcomes (ODI and EQ-5D) and the need for re-operation. This registry portion of the study aims to prospectively collect comparative data for these patients treated with either decompression alone or decompression with fusion.

NCT ID: NCT03434223 Terminated - Spinal Stenosis Clinical Trials

Prospective Follow-up of Elderly Patients Undergoing Instrumented Lumbar Arthrodesis Supplemented by the Implanet Jazz System(TM)

Start date: December 29, 2016
Phase:
Study type: Observational [Patient Registry]

Establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the Implanet Jazz System.

NCT ID: NCT03118206 Terminated - Surgery Clinical Trials

Comparison of the Effect of Lumbar Spinal Manipulation, Physical Therapy and Surgical Management in the Treatment of Lumbar Spinal Stenosis

Start date: January 2017
Phase: N/A
Study type: Interventional

To compare the effect of lumbar spinal manipulation, physical therapy and surgical management in the treatment of lumbar spinal stenosis.

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: NCT02761928 Terminated - Spinal Stenosis Clinical Trials

Investigation of Hypermobility, Biomarkers, and Pain Generators in Chronic Pain Patients

Hypermoble
Start date: January 2016
Phase:
Study type: Observational

Observational study of axial spine pain and hyperflexibility. Patients will receive physical exam maneuvers (traditional straight leg raise, FABER, facet loading as well as Beighton's hypermobility score) and blood / urine / saliva collection. They will also be separated into pain groups based on their response to injections. A correlation between exam findings and procedure group will be measured.

NCT ID: NCT02610335 Terminated - Clinical trials for Lumbar Spinal Stenosis

Evaluation of Spinal Mobility Reeducation in Patients Treated for a Lumbar Spinal Stenosis After Epidural Infiltration

CLEMOB
Start date: January 15, 2016
Phase: N/A
Study type: Interventional

In actual practice the patients with mild or moderate lumbar spinal stenosis symptoms receive an epidural infiltration and participate in kyphosis reeducation in first intention. Yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. The study assume that the spinal mobility reeducation will reduce the incidence of pain recurrences compared with the classic kyphosis reeducation.