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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2015-10-31

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.

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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.

Conditions

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Diskectomy Intervertebral Disk Displacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Anterior cervical discectomy, no disc prosthesis

Group Type ACTIVE_COMPARATOR

Anterior cervical discectomy

Intervention Type PROCEDURE

Removal of protruding cervical disc through an anterior approach

2

Anterior cervical discectomy, with disc prosthesis

Group Type EXPERIMENTAL

Activ C disc prosthesis

Intervention Type DEVICE

cervical disc prosthesis

Anterior cervical discectomy

Intervention Type PROCEDURE

Removal of protruding cervical disc through an anterior approach

Interventions

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Activ C disc prosthesis

cervical disc prosthesis

Intervention Type DEVICE

Anterior cervical discectomy

Removal of protruding cervical disc through an anterior approach

Intervention Type PROCEDURE

Other Intervention Names

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Activ C cervical disc prosthesis, B.Braun/Aesculap Spine

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No