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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 disc disease at a single level from C3-C4 to C6-C7.
This pivotal clinical trial is being conducted to compare treatment data of the investigational implant device,the PRESTIGE® LP Cervical Disc, with a control patient group receiving a plate. The PRESTIGE® LP Cervical Disc device will be implanted using an anterior surgical approach. Data from control patients receiving anterior cervical discectomy and fusion with an ATLANTIS Anterior Cervical Plate from the initial Artificial Cervical Disc study (IDE # G010188)will be compared as both treatment groups receive single-level surgical treatment from C3-C4 to C6-C7 for symptomatic cervical degenerative disc disease.
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cervical Degenerative Disc Disease
PRESTIGE® LP Cervical Disc, ATLANTIS Anterior Cervical Plate
Active, not recruiting
Medtronic Spinal and Biologics
Published on BioPortfolio: 2014-07-24T14:17:55-0400
This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervi...
The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease...
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 di...
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...
The aim of this study is to examine the clinical outcome after anterior cervical decompression and fusion, and cervical disc prostheses in general. Additionally these two surgical methods ...
Anterior cervical discectomy and fusion (ACDF) has been considered as a gold standard for symptomatic cervical disc degeneration (CDD), which may result in progressive degeneration of the adjacent seg...
Cervical total disc replacement (TDR) is an emerging technology. Cervical arthroplasty theoretically reduces the risk of adjacent level disc degeneration and segmental instability. However, the factor...
Combination of ACDF and ACCF (Anterior cervical discectomy or corpectomy with fusion) has been demonstrated to be effective for multi-level CSM (cervical spondylotic myelopathy). However, the combinat...
We conducted a retrospective cohort analysis of early outcomes after elective anterior cervical discectomy and fusion (ACDF) vs cervical artificial disc replacement (C-ADR) using the National Surgical...
A single-center, prospective comparative study of prospectively collected outcomes, with a minimum 12 months follow-up.
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.
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.
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)
A supernumerary rib developing from an abnormal enlargement of the costal element of the C7 vertebra. This anomaly is found in 1-2% of the population and can put pressure on adjacent structures causing CERVICAL RIB SYNDROME; THORACIC OUTLET SYNDROME; or other conditions.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...