Adventâ„¢ Cervical Disc Versus Anterior Cervical Discectomy and Fusion(ACDF) for Treatment of One Level Degenerative Disc Disease (IDE Study)
The purpose of this study is to establish the safety and effectiveness of the Adventâ„˘ 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).
Following surgery study subjects will be evaluated at the following intervals: 6 wks (Â± 2wks); 3 Months (Â±2 wks); 6 Month (Â±1 months); 12 and 24 Month (Â±2 months) and annually until the last subject enrolled completes their 24 Month follow-up
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Cervical Degenerative Disc Disease
Cervical Artificial Disc (Adventâ„˘ Cervical Disc), ACDF (Hallmarkâ„˘ Anterior Cervical Plate System with corticocancellous allograft bone)
University of California Davis
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00637312
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
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.
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.
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)
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