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Study of Safety & Effectiveness of PRESTIGE® LP Cervical Disc vs. Anterior Cervical Fusion in Cervical Degenerative Disc Disease

2014-07-24 14:17:55 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cervical Degenerative Disc Disease

Intervention

PRESTIGE® LP Cervical Disc, ATLANTIS Anterior Cervical Plate

Location

Montgomery Neurosurgical
Montgomery
Alabama
United States
36106

Status

Active, not recruiting

Source

Medtronic Spinal and Biologics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:17:55-0400

Clinical Trials [1519 Associated Clinical Trials listed on BioPortfolio]

An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine

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...

Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels

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...

Advent™ 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 Advent™ Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating degenerative di...

Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)

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...

Clinical Outcome After Anterior Cervical Decompression and Fusion and Cervical Total Disc Replacement

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 ...

PubMed Articles [3868 Associated PubMed Articles listed on BioPortfolio]

Discover cervical disc arthroplasty versus anterior cervical discectomy and fusion in symptomatic cervical disc diseases: A meta-analysis.

Symptomatic cervical disc disease (SCDD) is a common degenerative disease, and Discover artificial cervical disc, a new-generation nonconstrained artificial disk, has been developed and performed grad...

Multilevel cervical disc replacement versus multilevel anterior discectomy and fusion: A meta-analysis.

Cervical disc replacement (CDR) has been developed as an alternative surgical procedure to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical degenerative disc d...

Zero-profile spacer versus cage-plate construct in anterior cervical discectomy and fusion for multilevel cervical spondylotic myelopathy: A systematic review and meta-analysis.

Anterior cervical discectomy and fusion (ACDF) with plate-screw construct has been gradually applied for multilevel cervical spondylotic myelopathy (CSM) in recent years. However, long cervical plate ...

Comparison of Outcomes of Single-Level Anterior Cervical Discectomy With Fusion and Single-Level Artificial Cervical Disc Replacement for Single-Level Cervical Degenerative Disc Disease.

A single-center, prospective comparative study of prospectively collected outcomes, with a minimum 12 months follow-up.

3-Tesla Kinematic MRI of the Cervical Spine for Evaluation of Adjacent Level Disease After Monosegmental Anterior Cervical Discectomy and Arthroplasty: Results of 2-Year Follow-Up.

We prospectively evaluated adjacent disc levels after anterior cervical discectomy and arthroplasty (ACDA) using kinematic magnetic resonance imaging (MRI) and plain functional radiographs.

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.

The segment of the spinal cord within the CERVICAL VERTEBRAE.

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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