Maastricht University Medical Center
Maastricht, Limburg, 6229 HX, Netherlands
NCT Number: NCT00868335
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.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Maastricht, Limburg, 6229 HX, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
cervical disc prosthesis
Other names: Activ C cervical disc prosthesis, B.Braun/Aesculap Spine
Removal of protruding cervical disc through an anterior approach
Time frame: baseline, 3 months, 12 months
Time frame: Baseline, 3 months, 12 months
Time frame: Baseline, 3 months, 12 months
Time frame: Baseline, 3 months, 12 months
Maastricht University Medical Center
Other
Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without an Activ-C Cervical Disc Prosthesis.
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