Study of Safety & Effectiveness of PRESTIGEÂ® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical Degenerative Disc Disease
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
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00667459
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
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.
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 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 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...
Prestige artificial disc replacement is an alternative treatment option with 16 years of experience addressing the unmet needs of surgical fusion interventions. Previous studies on the PRE...
The purpose of this study is to find out if use of a cervical disc prosthesis in the treatment of a cervical disc herniation preserves or restores normal mobility and movement in the cervi...
Anterior cervical interbody grafts/cages combined with a plate were frequently used in multilevel discectomies/corpectomies. In order to avoid additional posterior stabilization in patients who underg...
To explore the clinical and radiological outcomes of Discover artificial cervical disc arthroplasty and the range of motion status on adjacent segments for cervical spondylosis causing radiculopathy o...
Anterior cervical discectomy and fusion (ACDF) is often complicated by subsidence, pseudoarthrosis, kyphosis, and graft donor site morbidities. To decrease the occurrence of these complications, vario...
Cervical disc degeneration can result in nerve root compression and severe symptoms that significantly impair the patient's quality of life. The purpose of this study is to investigate multiple diffus...
To determine the role of dynamic cervical implant (DCI) replacement for single-level degenerative cervical disc disease in Chinese patients.