Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis
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 cervical spine.
Intractable nerve pain to the arm caused by a cervical disc herniation is typically treated by removal of the protruding disc through an operation. Fusion of the discs follows in about 70% of cases.
Adjacent disc disease (ADD), symptomatic degenerative changes in the levels adjacent to the operated level is regarded as a late complication. Fusion at the operated level is thought to contribute to this process due to compensative increased mobility and stress on the adjacent segments.
Keeping the operated segment mobile through the use of a cervical disc prosthesis possibly prevents ADD.
We hypothesize that use of a cervical disc prosthesis preserves or restores normal mobility to the cervical spine. To test this hypothesis subjects are randomised in a group receiving a standard anterior cervical discectomy, and a group receiving a standard discectomy with placement of a cervical disc prosthesis. Digital X-ray cinematographic videos are made of a flexion/extension movement. The videos will be analyzed manually and through a newly designed automated program, to check for mobility and order of movement.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Activ C disc prosthesis, Anterior cervical discectomy
Maastricht University Medical Center
Maastricht University Medical Center
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00868335
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Excision, in part or whole, of an intervertebral disk. The most common indication is disk displacement or herniation. In addition to standard surgical removal, it can be performed by percutaneous diskectomy (DISKECTOMY, PERCUTANEOUS) or by laparoscopic diskectomy, the former being the more common.
A ready-made or custom-made prosthesis of glass or plastic shaped and colored to resemble the anterior portion of a normal eye and used for cosmetic reasons. It is attached to the anterior portion of an orbital implant (ORBITAL IMPLANTS) which is placed in the socket of an enucleated or eviscerated eye. (From Dorland, 28th ed)
A prosthetic appliance for the replacement of areas of the maxilla, mandible, and face, missing as a result of deformity, disease, injury, or surgery. When the prosthesis replaces portions of the mandible only, it is referred to as MANDIBULAR PROSTHESIS.
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.
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 evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical verte...
The purpose of the study is to evaluate the safety and effectiveness of the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between...
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 objective of this clinical investigation is to compare the safety and effectiveness of ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomat...
INTRODUCTION: There is considerable controversy as to which technique is best option for reconstruction after multilevel anterior decompression for cervical spondylosis. The aim...
BACKGROUND: The current standard of care for cervical myopathy is anterior discectomy and fusion (ACDF). Although well tolerated in the short term, this treatment might ultimatel...
STUDY DESIGN.: Retrospective study of the difference of heterotopic ossification (HO) occurrence according to 3 different types of prosthesis. OBJECTIVE.: This study was designed to investigate the di...
OBJECTIVE: Our goal was to increase the safety of anterior cervical discectomy, a routine surgery performed by neurosurgeons worldwide, in the face of vertebral artery (VA) anomalies. CLINICAL PRESENT...
STUDY DESIGN.: Case report. OBJECTIVE.: To present a rare case of a patient who during posterior lumbar spinal decompression and diskectomy underwent a laceration of the aorta. The patient survived wi...