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Spinal Stenosis clinical trials

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NCT ID: NCT01921530 Recruiting - Spinal Stenosis Clinical Trials

Interbody vs Instrumented Posterolateral Fusion Following Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis

Start date: December 2013
Phase: Phase 4
Study type: Interventional

Degenerative spondylolisthesis describes the slip of one spinal segment relative to the adjacent segment. It is usually associated with spinal stenosis (which limits one's ability to walk and stand) and is the most common indication for surgery in adults over age 65 years. A variety of surgical techniques are available; the most common are the Posterolateral Instrumented Fusion (PLF), and Interbody Fusion (IF) including Posterolateral Interbody Fusion (PLIF), and Transforaminal Interbody fusion (TLIF). IF uses a cage that is placed within the cleaned out disc space between the vertebral bodies being fused. Although this approach achieves a good fusion rate and deformity correction it is associated with a higher surgical cost and potential intra-operative complication rate. What is more, no consensus exists as to whether IF provides better patient rated functional outcome and quality of life. If the advantages of IF do not translate into superior patient rated outcomes, then the risk-benefit ratio would be tipped in favor of PLF. The purpose of this study is to determine if IF is equivalent to PLF for the treatment of degenerative spondylolisthesis. The investigators will conduct a prospective randomized control trial comparing these two procedures. Our primary outcome measure will be the Oswestry Disability Index, which evaluates spinal pain and function.

NCT ID: NCT01918943 Recruiting - Low Back Pain Clinical Trials

Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain

Start date: August 2012
Phase: N/A
Study type: Observational

Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and degenerative scoliosis. Many techniques evolved since then, from wiring, rods, pedicle screws, and recently inter-spinous fixation devices like the Aspen. Along its evolutionary trail, various methods for achieving circumferential fusion have arisen. Distinct from staged anterior/posterior fusion techniques, two methods of achieving an interbody fusion from a posterior approach have emerged: posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF). Recently, the lateral approach for interbody fusion (XLIF) has became a more common technique, requiring in some cases, complemental posterior fixation with pedicle screws, facet screws or interspinous fixation devices like the Aspen device. In this study, we address the clinical and radiological outcome of a novel technique using standard PLIF interbody fusion and insertion of the Aspen device via posterior lumbar approach.

NCT ID: NCT01902979 Recruiting - Obesity Clinical Trials

The Spinal Stenosis Pedometer and Nutrition e-Health Lifestyle Intervention (SSPANLI) Trial

SSPANLI
Start date: September 2013
Phase: N/A
Study type: Interventional

Obesity is one of the most important determinants of quality of life and function. People with lumbar spinal stenosis may be at increased risk of obesity given walking limitations. Spinal stenosis is a very common degenerative condition in people over 45. People with this condition have pain and numbness in the legs during walking, and therefore avoid physical activity. Lack of physical activity is related to weight gain and increased risk of chronic disease. Objective: The objective of this project is test a new e-health (online) pedometer and nutrition intervention aimed at promoting weight loss and increasing physical activity in overweight and obese individuals with spinal stenosis. Methods: The investigators will recruit 88 people with lumbar spinal stenosis who are overweight or obese. Half of these people will receive the 12-week intervention, and the other half will receive usual care (no intervention). In Weeks 1 and 6, people in the intervention group will meet with a Registered Dietitian and an Exercise Physiologist for personalized sessions. They will receive a pedometer and instructions on how to log in to the e-health site (https://sspanli.mtroyal.ca). They will wear the pedometer daily and log in to the website each week for a nutrition education session, a weekly step goal, and tips. The investigators will look to see whether people in the intervention group show greater change in physical activity, body composition and quality of life compared to the individuals who received usual care. Relevance: The increasing number of people with spinal stenosis represents a huge health care burden in Canada. This intervention could provide a new treatment option that would increase mobility, quality of life, and potentially alleviate the need for expensive treatments like surgery. E-health interventions provide an opportunity for patients to take an active role in their own health, and promote behaviour changes that will result in healthier Canadians less likely to access care in the future.

NCT ID: NCT01892878 Withdrawn - Spinal Stenosis Clinical Trials

Clinical Outcome and Fusion Results Using the VerteLoc® Facet Fixation Device

Start date: July 2013
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to evaluate fusion of the facet joints in a prospective cohort of patients utilizing the VerteLoc facet fixation device in patients receiving lumbar laminectomy (L1-S1), without ancillary stabilization devices such as pedicle and transfacet screws.

NCT ID: NCT01888536 Completed - Clinical trials for Neurologic Claudication in Patients With Lumbar Spinal Stenosis

A Study to Evaluate Efficacy of 『Opast Tablet』for Neurologic Claudication in Patients With Lumbar Spinal Stenosis

Start date: February 2013
Phase: Phase 4
Study type: Interventional

This trial is a comparative study of Opast tablet and Rikalin capsule 75mg and Rikalin capsule 75mg in combination with Opast tablet to evaluate improvement effectiveness of Opast tablet on subjective symptoms and neurologic claudication in patients with lumbar spinal stenosis.

NCT ID: NCT01861743 Terminated - Spinal Stenosis Clinical Trials

Multimodal Analgesia Versus Routine Care Pain Management

MMA
Start date: April 2013
Phase: N/A
Study type: Interventional

Most patients undergoing surgery experience significant post-operative pain. Inadequate peri-operative pain management may decrease post-operative mobilization and increase length of hospitalization. Additionally, poorly managed acute post-operative pain analgesia is associated with an increased risk of developing chronic pain and delayed wound healing. Lumbar spine surgery is particularly painful, often requiring a multi-day hospitalization. The most common post-operative analgesia used in spine surgery is narcotic medication delivered via an intravenous patient controlled analgesia (IV PCA). A multimodal peri-operative pain management protocol for spine surgery has the potential to not only decrease pain but also to improve recovery, decrease narcotic consumption, decrease length of stay in the hospital and reduce both direct and indirect hospital costs. The purpose of this study is to determine if post-operative pain and rate of recovery are improved in patients undergoing spine surgery using MMA compared to usual analgesic care.

NCT ID: NCT01829997 Completed - Clinical trials for Degenerative Disc Disease

Assessment of nanOss Bioactive 3D in the Posterolateral Spine

Start date: April 2013
Phase: N/A
Study type: Interventional

Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used. However, complications can develop when the bone graft material used is insufficient to achieve the desired fusion. With its unique properties, nanOss Bioactive 3D can be mixed with bone marrow aspirate (BMA) and autograft bone to obtain new bone growth during the healing process. nanOss Bioactive 3D is approved for use in the U.S., however, additional information is useful to assess its efficacy in the posterolateral spine. The purpose of this study is to assess fusion results in the posterolateral spine using nanOss Bioactive 3D mixed with autograft bone and BMA. It is hypothesized that the use of nanOss Bioactive 3D will result in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than 5 degrees of angular motion.

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: NCT01716182 Terminated - Clinical trials for Degenerative Disc Disease

RAMP Study: A Study Comparing Two Lumbar Fusion Procedures

RAMP
Start date: June 2012
Phase: N/A
Study type: Observational

This is a post-marketing, on-label Efficacy, Effectiveness and Safety Study designed in a Multicenter, Randomized, Prospective format. This study compares two spinal fusion procedures, Transacral Interbody Fusion and Transforaminal Lumbar Interbody Fusion (TLIF). Enrollment period will be approximately 12-18 months; each Principal Investigator/Study Center will be expected to enroll up to 20 subjects. The protocol requires approximately 7 subject visits to the study center from screening through the final follow-up visit.

NCT ID: NCT01630382 Not yet recruiting - Spinal Stenosis Clinical Trials

Cerebrospinal Fluid Congestion in Spinal Stenosis Patients

Start date: June 2012
Phase: N/A
Study type: Observational

The investigators hypothesized spinal stenosis symptom was provocation due to cerebrospinal fluid congestion.