Intervertebral Disk Displacement Clinical Trial
Official title:
Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without an Activ-C 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
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