An interventional study of Activ C disc prosthesis and Anterior cervical discectomy in Diskectomy and Intervertebral Disk Displacement, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-03-22.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
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.
478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.
This study's enrollment of 24 is below the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.
Browse Intervertebral Disc Displacement studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Anterior cervical discectomy, no disc prosthesis
Procedure: Anterior cervical discectomy
Anterior cervical discectomy, with disc prosthesis
Device: Activ C disc prosthesis · Procedure: Anterior cervical discectomy
cervical disc prosthesis
Also known as: Activ C cervical disc prosthesis, B.Braun/Aesculap Spine
Removal of protruding cervical disc through an anterior approach
Order of movement
Time frame: baseline, 3 months, 12 months
Segmental mobility
Time frame: Baseline, 3 months, 12 months
Treatment of symptoms (pain, neurological assessment)
Time frame: Baseline, 3 months, 12 months
Influence on subjects functioning (social, work)
Time frame: Baseline, 3 months, 12 months
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Displacement→
Maastricht University Medical Center