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Spinal Stenosis clinical trials

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NCT ID: NCT01057641 Terminated - Clinical trials for Lumbar Spinal Stenosis

Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant

Start date: March 2011
Phase: Phase 4
Study type: Interventional

Neurogenic intermittent claudication is a specific symptom complex occurring in patients with lumbar spinal stenosis. Characteristic of this disease is the occurrence of increasing leg, buttock or groin pain with or without lower back pain when walking a certain distance or reclining. Bending forward or sitting leads to a rapid pain relief. Lumbar spinal stenosis is defined as a reduction of the diameter of the spinal canal. The mechanism leading to stenosis is a remodeling and overgrowth of the spinal canal with osteophyte formation. Any loss of tissue or decrease of the disc height results in a relative laxity of the ligament structures and accelerates the degeneration of the spinal joints. As a therapy option, conservative therapy with oral analgesics and physical therapy is considered. This treatment can be intensified by adding epidural pain treatment. Is the conservative treatment not successful surgical intervention is necessary. In patients over 65 years of age operative decompression of the lumbar spinal stenosis constitutes the most common surgical operation of the spine. A relatively new therapy alternative is the interspinous process decompression (IPD). Studies have shown that the IPDs prevent narrowing of the spinal canal and neural foramens. The study is intended as a randomised, monocentre study to investigate the safety and the benefit of a minimally invasive percutaneous IPD-device in comparison with the best non-surgical operative treatment of lumbar spinal stenosis.

NCT ID: NCT00974623 Terminated - Clinical trials for Degenerative Disc Disease

Bone Graft Materials Observational Registry

APPROACH-001
Start date: September 2009
Phase: N/A
Study type: Observational

A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.

NCT ID: NCT00762723 Terminated - Clinical trials for Degenerative Disc Disease

Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws

Start date: February 2008
Phase: N/A
Study type: Interventional

Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability. The system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The device's bone-plate interface is enhanced through use of fixed-angled screws,variable-angle screws or a combination of both to accommodate various combinations of screw configurations, resulting in enhanced fixation tailored to individual patient needs. Clinical outcomes data, including a comparison of different screw configurations, is needed to support the use and of the Trinica ALP System.

NCT ID: NCT00759057 Terminated - Spinal Stenosis Clinical Trials

A Clinical Study of the Dynesys(R) Spinal System

Start date: March 2003
Phase: Phase 3
Study type: Interventional

This non-inferiority study will compare the clinical outcomes of subjects implanted with the Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented posterior lateral spinal fusion.

NCT ID: NCT00697827 Terminated - Spinal Stenosis Clinical Trials

A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis

In-Space
Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels.

NCT ID: NCT00627497 Terminated - Clinical trials for Degenerative Lumbar Spinal Stenosis

DIAMâ„¢ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion

Start date: February 2008
Phase: Phase 3
Study type: Interventional

The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System as a method of treating patients with symptoms of degenerative lumbar spinal stenosis at a single level from L2 to L5.

NCT ID: NCT00546949 Terminated - Clinical trials for Lumbar Spinal Stenosis

Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-invasive Decompression to X-stop

LSSS
Start date: March 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to compare two surgery methods on lumbar spinal stenosis: minimal invasive decompression and X-stop. It is a prospective randomized multicenter study including patients with lumbar spinal stenosis on one or two levels, and neurogenic intermittent claudication. Effect assessment will include measures of pain and self-evaluated health condition, a full economical evaluation, and areal measurements (MR imaging and roentgen analyses)

NCT ID: NCT00529997 Terminated - Clinical trials for Lumbar Spinal Stenosis

Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System

Start date: February 2007
Phase: N/A
Study type: Interventional

The purpose of this trial is to assess whether the Stabilimax NZ® is at least as safe and effective as the control therapy of fusion in patients receiving decompression surgery for the treatment of clinically symptomatic spinal stenosis at one contiguous vertebral levels from L1-S1. Safety and effectiveness will be assessed by means of primary study endpoints which address improvements in pain and function in the absence of major device related complications. The study hypothesis criteria for demonstrating safety and efficacy requires scientific evidence that patients classified as satisfying the primary study endpoint post device implantation is at least as good for Stabilimax NZ® recipients as that for patients undergoing fusion with posterior pedicle screw instrumentation at the 24 month followup assessment.

NCT ID: NCT00517751 Terminated - Clinical trials for Lumbar Spinal Stenosis

Condition of Approval Study

COAST
Start date: August 2007
Phase: Phase 4
Study type: Interventional

This prospective, multicenter longitudinal five-year study of X-STOP PEEK usage in LSS patients is designed to supplement pre-market safety and effectiveness data with information on longer-term device performance in a population of patients with moderately impaired physical function at preoperative baseline (i.e., an "indicated" population) who elect to undergo X STOP PEEK surgery.

NCT ID: NCT00480311 Terminated - Clinical trials for Lumbar Spinal Stenosis

World Health Organization Disability Assessment Schedule II (WHODAS-II) for Patients With Symptomatic Lumbar Spinal Stenosis

Start date: April 2007
Phase: N/A
Study type: Observational

The main purpose of this study is to determine the measurement characteristics of WHODAS-II (World Health Organization Disability Assessment Schedule II), as well as to analyze its correlation with symptomatic lumbar spinal stenosis (Visual Analog Scale, VAS), disability (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of the FAB Questionnaire, FABQ), and quality of life (SF-12). Measurements will be taken at baseline and 6 days later (day 7).