Adventâ„¢ Cervical Disc Versus Anterior Cervical Discectomy and Fusion(ACDF) for Treatment of One Level Degenerative Disc Disease (IDE Study)
Summary
The purpose of this study is to establish the safety and effectiveness of the Advent™ Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating degenerative disc disease at a single-level in the cervical spine (from C3 to C7) following cervical discectomy in skeletally mature patients (at least 18 years of age).
Description
Following surgery study subjects will be evaluated at the following intervals: 6 wks (± 2wks); 3 Months (±2 wks); 6 Month (±1 months); 12 and 24 Month (±2 months) and annually until the last subject enrolled completes their 24 Month follow-up
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Conditions
Cervical Degenerative Disc Disease
Intervention
Cervical Artificial Disc (Advent™ Cervical Disc), ACDF (Hallmark™ Anterior Cervical Plate System with corticocancellous allograft bone)
Location
University of California Davis
Sacramento
California
United States
95816
Status
Suspended
Source
Orthofix, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00637312
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Electrophoresis, Disc
Electrophoresis in which discontinuities in both the voltage and pH gradients are introduced by using buffers of different composition and pH in the different parts of the gel column. The term 'disc' was originally used as an abbreviation for 'discontinuous' referring to the buffers employed, and does not have anything to do with the shape of the separated zones.
Cervical Plexus
A network of nerve fibers originating in the upper four cervical spinal cord segments. The cervical plexus distributes cutaneous nerves to parts of the neck, shoulders, and back of the head, and motor fibers to muscles of the cervical spinal column, infrahyoid muscles, and the diaphragm.
Cervical Length Measurement
A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.
Cervical Atlas
The first cervical vertebra.
Cervical Rib Syndrome
A condition associated with compression of the BRACHIAL PLEXUS; SUBCLAVIAN ARTERY; and SUBCLAVIAN VEIN at the thoracic outlet and caused by a complete or incomplete anomalous CERVICAL RIB or fascial band connecting the tip of a cervical rib with the first thoracic rib. Clinical manifestations may include pain in the neck and shoulder which radiates into the upper extremity, PARESIS or PARALYSIS of brachial plexus innervated muscles; sensory loss; PARESTHESIAS; ISCHEMIA; and EDEMA. (Adams et al., Principles of Neurology, 6th ed, p214)
Clinical Trials
The purpose of this study is to determine the safety and effectiveness of the DISCOVER Artificial Cervical Disc in the treatment of degenerative disc disease in one level in the cervical s...
SECURE®-C Cervical Artificial Disc Clinical Study
The purpose of the study is to evaluate the safety and effectiveness of the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between...
Kineflex-C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD)
The purpose of this study is to show that the Kineflex-C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenera...
The purpose of this clinical trial is to evaluate the safety and effectiveness of the PRESTIGE® LP Cervical Disc as a method of treating patients with symptoms of cervical degenerative di...
The purpose of the study is to evaluate the performance of the Discover cervical Artificial disc in the treatment of degenerative disc disease in one level of the cervical spine.
PubMed Articles
INTRODUCTION: There is considerable controversy as to which technique is best option for reconstruction after multilevel anterior decompression for cervical spondylosis. The aim...
BACKGROUND: The current standard of care for cervical myopathy is anterior discectomy and fusion (ACDF). Although well tolerated in the short term, this treatment might ultimatel...
OBJECTIVE: To evaluate the effects of cervical artificial disc replacement (ADR) and anterior discectomy and fusion (ACDF) on adjacent spinal alignments. METHODS: The cohort consisted of 33 patients w...
Upper thoracic spine arthroplasty via the anterior approach.
Significant progress has been made in lumbar and cervical disc replacement therapy. Several cervical disc prostheses have recently gained FDA approval. Although arthroplasty has not been previously de...
Complex Regional Pain Syndrome Associated with Cervical Disc Protrusion and Foraminotomy.
Abstract Study Design. Case report. Objective. To report a previously undescribed association between complex regional pain syndrome (CRPS) and surgery for cervical disc protrusion. Summary of Backgro...
