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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

Tracking Information
First Submitted Date  ICMJE March 23, 2009
First Posted Date  ICMJE March 24, 2009
Last Update Posted Date March 22, 2016
Study Start Date  ICMJE December 2007
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2009)
  • Order of movement [ Time Frame: baseline, 3 months, 12 months ]
  • Segmental mobility [ Time Frame: Baseline, 3 months, 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis
Official Title  ICMJE Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without an Activ-C Cervical Disc Prosthesis.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diskectomy
  • Intervertebral Disk Displacement
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Anterior cervical discectomy, no disc prosthesis
    Intervention: Procedure: Anterior cervical discectomy
  • Experimental: 2
    Anterior cervical discectomy, with disc prosthesis
    Interventions:
    • Device: Activ C disc prosthesis
    • Procedure: Anterior cervical discectomy
Publications * Boselie TF, van Mameren H, de Bie RA, van Santbrink H. Cervical spine kinematics after anterior cervical discectomy with or without implantation of a mobile cervical disc prosthesis; an RCT. BMC Musculoskelet Disord. 2015 Feb 21;16:34. doi: 10.1186/s12891-015-0479-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2009)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00868335
Other Study ID Numbers  ICMJE CWK-Tracking01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Toon Boselie, Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE B. Braun/Aesculap Spine
Investigators  ICMJE
Principal Investigator: H van Santbrink, MD, PhD Department of Neurosurgery, Maastricht University Medical Center
PRS Account Maastricht University Medical Center
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP