Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without an Activ-C Cervical Disc Prosthesis.

Conditions
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Diskectomy, Intervertebral Disk Displacement

Intervention / Treatment
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* Device: Activ C disc prosthesis
* Procedure: Anterior cervical discectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication for anterior cervical discectomy monoradicular syndrome caused by compression at C5-6 or C6-7 monosegmental disease on MRI able to actively perform flexion/extension movement segmental mobility on the afflicted level >2 degrees of rotation informed consent Exclusion Criteria: previous operative interventions on the cervical spine multiple segments afflicted positive L'Hermittes sing Active infection Immature bone Tumorous processes in the cervical region Previous radiation therapy in the cervical region Pregnancy Cervical myelopathy not able to speak Dutch

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Anterior cervical discectomy, no disc prosthesis | Procedure: Anterior cervical discectomy<br>* Removal of protruding cervical disc through an anterior approach<br>|
| Experimental: 2<br>Anterior cervical discectomy, with disc prosthesis | Device: Activ C disc prosthesis<br>* cervical disc prosthesis<br>* Other names: Activ C cervical disc prosthesis, B.Braun/Aesculap Spine;Procedure: Anterior cervical discectomy<br>* Removal of protruding cervical disc through an anterior approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Order of movement |  | baseline, 3 months, 12 months | 
| Segmental mobility |  | Baseline, 3 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of symptoms (pain, neurological assessment) |  | Baseline, 3 months, 12 months | 
| Influence on subjects functioning (social, work) |  | Baseline, 3 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical degenerative disc disease, Anterior cervical discectomy, Cervical disc prosthesis, Activ-C, Mobility, Movement