A Clinical Study of the Dynesys(R) Spinal System
Summary
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.
Description
The purpose of this clinical study is to demonstrate the safety and effectiveness of the Dynesys Spinal System for patients requiring one or contiguous two-level posterior spinal stabilization of the lumbar, and/or sacral spine following decompression. The ability for this implant to maintain spinal alignment and non-fusion of spinal segments, while positively affecting clinical outcomes, will be assessed and compared to a posterior lateral spinal fusion (PLF) procedure using autogenous bone with a semi-rigid, polyaxial posterior spinal fixation system.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Conditions
Degenerative Spondylolisthesis or Retrolisthesis
Intervention
Posterior Pedicle Screw System
Location
Scottsdale Spine Center
Scottsdale
Arizona
United States
85251
Status
Active, not recruiting
Source
Zimmer, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00759057
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Myopia, Degenerative
Excessive axial myopia associated with complications (especially posterior staphyloma and CHOROIDAL NEOVASCULARIZATION) that can lead to BLINDNESS.
Paraneoplastic Syndromes, Nervous System
Degenerative or inflammatory conditions affecting the central or peripheral nervous system that develop in association with a systemic neoplasm without direct invasion by tumor. They may be associated with circulating antibodies that react with the affected neural tissue. (Intern Med 1996 Dec;35(12):925-9)
Hypothalamus, Posterior
The part of the hypothalamus posterior to the middle region consisting of several nuclei including the medial mamillary nucleus, lateral mamillary nucleus, and posterior hypothalamic nucleus (posterior hypothalamic area). The posterior hypothalamic area is concerned with control of sympathetic responses and is sensitive to conditions of decreasing temperature and controls the mechanisms for the conservation and increased production of heat.
Screw Worm Infection
Infection with larvae of the blow fly Cochliomyia hominivorax (Callitroga americanum), a common cause of disease in livestock in the southern and southwestern U.S.A.
Infarction, Posterior Cerebral Artery
NECROSIS induced by ISCHEMIA in the POSTERIOR CEREBRAL ARTERY distribution system which supplies portions of the BRAIN STEM; the THALAMUS; TEMPORAL LOBE, and OCCIPITAL LOBE. Depending on the size and location of infarction, clinical features include OLFACTION DISORDERS and visual problems (AGNOSIA; ALEXIA; HEMIANOPSIA).
Clinical Trials
Evaluation of the PediGuard™ for Pedicle Screw Insertion
The aim of the study is to determine the relative effectiveness of the PediGuardTM , a device manufactured by SpineVision, Inc, for placement of a pedicle screw pilot (drill) hole and for...
Efficacy of the Aspen Spinous Process System in Anterior Lumbar Interbody Fusion (ALIF)
This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with degenerative disc disease (DDD) treated with ALIF and supplemental posterior...
Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis
Study to evaluate the superiority of the osteosynthesis associated with a decompressive surgery in comparison with a simple decompressive surgery in the treatment of lumbar degenerative st...
Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
The purpose of this study is to compare patients who underwent decompression/discectomy with pedicle screw fusion to patients who received decompression/discectomy without fusion.
Spine Patient Outcomes Research Trial (SPORT): Degenerative Spondylolisthesis With Spinal Stenosis
This study tests the effectiveness of different treatments for the three most commonly diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of two commo...
PubMed Articles
A slip above a slip: retrolisthesis of the motion segment above a spondylolytic spondylolisthesis.
OBJECTIVE: The purpose of this study is to assess the degenerative changes in the motion segments above a L5S1 spondylolytic spondylolisthesis and to view these in light of the retrolisthesis in the s...
Degenerative cervical spondylolisthesis: a systematic review.
PURPOSE: Degenerative cervical spondylolisthesis has received insufficient attention, in contrast to degenerative lumbar spondylolisthesis. In fact, degenerative cervical spondylolisthesis may be more...
STUDY DESIGN.: Retrospective clinical data analysis. OBJECTIVE.: To investigate the misplacement rate and related clinical complications of percutaneous pedicle screw insertion in the thoracic and lum...
Recent studies have demonstrated excellent results in treating isthmic spondylolisthesis via an anterior lumbar interbody fusion (ALIF). The authors describe 3 patients with isthmic spondylolisthesis...
Posterior pedicle screw fixation is now the standard treatment for surgical correction of idiopathic scoliosis and has largely replaced anterior techniques, but there have been reports describing a lo...
