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Spinal Stenosis clinical trials

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NCT ID: NCT02348645 Active, not recruiting - Spinal Stenosis Clinical Trials

Decompression vs. Fusion for Stable Degenerative Spondylolisthesis

Start date: July 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the feasibility of a full-scale multicenter randomized, controlled trial comparing the effectiveness of two surgical treatments for a condition associated with lumbar spinal stenosis called degenerative lumbar spondylolisthesis. Both treatments are currently used, but individual surgeons use different selection criteria for each treatment and use the procedures at different rates. The two procedures are decompression with fusion (the most common surgical procedure for spondylolisthesis) and midline-sparing decompression alone (which is also a standard treatment, but is not as widely used for treating spondylolisthesis). The investigators plan to collect the evidence on the following: 1. The feasibility of the trial protocol, and 2. Preliminary data on the effectiveness of each treatment.

NCT ID: NCT02007083 Active, not recruiting - Clinical trials for Lumbar Spinal Stenosis

The NORDSTEN Studies/ The Spinal Stenosis Study

NORDSTEN/SST
Start date: November 2013
Phase: N/A
Study type: Interventional

Lumbar Spinal Stenosis (LSS) is a clinical entity were narrowing of the spinal canal gives a compression of the the neural and vascular structures in the spinal canal. This often gives neurogenic claudication and sometimes severe Low Back Pain (LBP). Surgery for LSS is today the most often performed procedure in the adult lumbar spine. Beneficial effect of surgical treatment is well documented by several clinical trials, and a Cochrane review article from 2005 concludes that surgical treatment is superior to non-surgical treatment. The surgical solution is to decompress the stenotic part of the lumbar spine. There is no consensus in the literature of which surgical method that gives best long term clinical results. The investigators are therefore planning a Randomized Controlled Trial, where they will compare clinical and radiological results of three different surgical methods for LSS. The main outcome of this study is to answer which surgical method that gives the best long term clinical results. And, secondary outcome is to find out how much increase of the Dural Sac Cross Sectional Area is needed to give a long time relief of the patients` symptoms.

NCT ID: NCT01727752 Active, not recruiting - Clinical trials for Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis

A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis

FELIX
Start date: October 2007
Phase: N/A
Study type: Interventional

A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis

NCT ID: NCT01618435 Active, not recruiting - Spinal Stenosis Clinical Trials

The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Spondylodesis Operation in the Elderly With Spinal Stenosis Due to Degenerative Spondylolisthesis

IVANOS
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The average life expectancy in Denmark is increasing resulting in an increasing part of the population having age-related disease, ex lumbar spinal stenosis (LSS). LSS causes constriction of the nerves in the lumbar spine resulting in pain in the legs and lower back, especially when standing and walking, known as neurogenic claudication(Goh KJ FAU - Khalifa et al.). LSS occurs in a combination of degenerative changes in the lower back, including hypertrophy of the ligamentum flavus, arthrosis of the facet joints and bulging of the disc. Current treatment of LSS is varied ranging from non-operative conservative treatment to operation. Operative intervention shows very good results according to physical ability and pain(Christensen FB et al.;Hee HT and Wong;McGregor AH FAU - Hughes and Hughes;Xu et al.), but the most optimal treatment is still debated. Nevertheless, a decompression and, if needed, a spinal fusion is recommended.(Ausman). Clinical improvement including decrease of pain, improved ADL-function and an increased quality of life are parameters of highest interest and the purpose of an operation is clear: Making sufficient room for the affected nerves. In addition fusion is desired achieving stability avoiding a new compression of the nerves. Studies attending these issues find a correlation between fusion and clinical outcome, why obtained fusion of the affected levels are very important(Andersen et al.;Andersen et al.;Girardo et al.;Kornblum MB FAU - Fischgrund et al.). P-15, bound to Anorganisk Bone Mineral (ABM), called i-FACTOR®, shows fusion superiority, no side effects and no risk of transferring disease(Thorwarth et al. 5648-57;Thorwarth et al. 789-95;Wenz, Oesch, and Horst 1599-606;Scarano et al. 318-24;Kubler et al. 171-79) why the investigators find this material suited for fusion surgery in the elderly. To the investigators knowledge this is the first prospective study comparing fusion rates and postoperative clinic with i-FACTOR vs allograft in older patients operated with decompression and spondylodesis because of spinal stenosis due to degenerative spondylolisthesis. Hypothesis: There are no difference in the clinical parameters measured by ODI and fusion rates comparing i-FACTOR® and allograft in non-instrumented posterolateral spondylodesis-operations in patients 60 years and older.

NCT ID: NCT01338766 Active, not recruiting - Clinical trials for Lumbar Spinal Stenosis

Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression

STRiDE
Start date: April 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the clinical performance of a decompression using the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55% positive response rate.

NCT ID: NCT01067014 Active, not recruiting - Clinical trials for Lumbar Spinal Stenosis

The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery

Start date: February 2010
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the clinical performance of the iO-Flex® System in reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis that requires surgery.

NCT ID: NCT01053364 Active, not recruiting - Clinical trials for Lumbar Spinal Stenosis

Feasibility Study of NL-Prow Interspinous Spacer to Treat Lumbar Spinal Stenosis

Start date: January 2010
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the clinical safety and feasibility of the NL-Prow™ Interspinous Spacer implant and insertion procedure in the treatment of lumbar spinal stenosis

NCT ID: NCT00418197 Active, not recruiting - Low Back Pain Clinical Trials

Total Facet Arthroplasty System®(TFAS®) Clinical Trial

Start date: August 2005
Phase: Phase 3
Study type: Interventional

The Archus Total Facet Arthroplasty System® (TFAS®) is a non-fusion spinal implant indicated for treatment of patients with moderate to severe spinal stenosis. TFAS® replaces the diseased facets following surgical removal. TFAS® offers the surgeon new options for treating spinal stenosis patients, enabling a more comprehensive decompression via complete removal of the facets. TFAS® also offers an alternative to rigid spinal fusion fixation enabling intervertebral motion. The clinical trial is intended to demonstrate restoration of stability and sagittal balance to the spine. TFAS® also eliminates the need for painful bone graft harvest from the patient's hip which may be required with fusion procedures.