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The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level anterior cervical discectomy and fusion with Anterior Cervical Plate Fixation.
This is a prospective, multicenter, randomized, single-blinded, controlled study evaluating safety and preliminary efficacy of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) combined with MasterGraft Matrix in a commercially available PEEK cervical Spacer compared to an active control in subjects undergoing 2 or 3 level anterior cervical discectomy and fusion with anterior cervical plate fixation.
Subjects will be evaluated at the same time points for safety.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Cervical Degenerative Disc Disease
Anterior Cervical Discectomy and Fusion with NeoFuse, Anterior Cervical Discectomy and Fusion with Granules
Monash Medical Centre
Published on BioPortfolio: 2014-07-23T21:09:30-0400
Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior c...
The objective of this clinical investigation is to compare patients treated with Anterior Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a concurrent...
The purpose of this study is firstly to determine the efficacy of cervical plate for anterior cervical discectomy and fusion using cervical cage, and secondly to investigate the determinin...
Detect the reason for the frequently occurring C5 palsy after anterior cervical discectomy and fusion
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 effect of anterior cervical discectomy without fusion (ACD), ACD with fusion by stand-alone cage (ACDF) or with arthroplasty (ACDA) on cervical sagittal alignment is not known and is the subject o...
Surgery for cervical radiculopathy is often approached by either anterior cervical discectomy and fusion (ACDF) or posterior cervical foraminotomy (PCF). ACDF is more common; however, recent single ce...
Anterior cervical discectomy and fusion (ACDF) and laminoplasty (LP) are the most commonly performed procedures for degenerative cervical spondylosis. Cervical sagittal alignment (CSA) has recently be...
The purpose of this study is to compare the efficacy and safety of anterior cervical discectomy and fusion (ACDF) and cervical total disc replacement (CTDR) as revision surgeries for symptomatic adjac...
Comparison of the adverse events of anterior cervical disc replacement versus anterior cervical discectomy and fusion: A protocol for a systematic review and meta-analysis of prospective randomized controlled trials.
In the current surgical therapeutic regimen for symptomatic cervical degenerative disc disease, both anterior cervical discectomy and fusion (ACDF) and anterior cervical disc replacement (ACDR) are st...
A rare developmental defect in which the heart is abnormally located partially or totally outside the THORAX. It is the result of defective fusion of the anterior chest wall. Depending on the location of the heart, ectopia cordis can be thoracic, thoracoabdominal, abdominal, and cervical.
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 calcification of the posterior longitudinal ligament of the spinal column, usually at the level of the cervical spine. It is often associated with anterior ankylosing hyperostosis.