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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00868335
Recruitment Status : Completed
First Posted : March 24, 2009
Last Update Posted : March 22, 2016
Sponsor:
Collaborator:
B. Braun/Aesculap Spine
Information provided by (Responsible Party):
Toon Boselie, Maastricht University Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diskectomy Intervertebral Disk Displacement Device: Activ C disc prosthesis Procedure: Anterior cervical discectomy Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without an Activ-C Cervical Disc Prosthesis.
Study Start Date : December 2007
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Anterior cervical discectomy, no disc prosthesis
 Procedure: Anterior cervical discectomy
Removal of protruding cervical disc through an anterior approach
Experimental: 2
Anterior cervical discectomy, with disc prosthesis
 Device: Activ C disc prosthesis
cervical disc prosthesis
Other Name: Activ C cervical disc prosthesis, B.Braun/Aesculap Spine

Procedure: Anterior cervical discectomy
Removal of protruding cervical disc through an anterior approach


Outcome Measures
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Primary Outcome Measures :
  1. Order of movement [ Time Frame: baseline, 3 months, 12 months ]
  2. Segmental mobility [ Time Frame: Baseline, 3 months, 12 months ]

Secondary Outcome Measures :
  1. Treatment of symptoms (pain, neurological assessment) [ Time Frame: Baseline, 3 months, 12 months ]
  2. Influence on subjects functioning (social, work) [ Time Frame: Baseline, 3 months, 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868335


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
B. Braun/Aesculap Spine
Investigators
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Principal Investigator: H van Santbrink, MD, PhD Department of Neurosurgery, Maastricht University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Toon Boselie, MD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00868335    
Other Study ID Numbers: CWK-Tracking01
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Keywords provided by Toon Boselie, Maastricht University Medical Center:
Cervical degenerative disc disease
Anterior cervical discectomy
Cervical disc prosthesis
 Activ-C
Mobility
Movement
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Spinal Diseases
Bone Diseases
 Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical