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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
B. Braun/Aesculap Spine
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00868335
First received: March 23, 2009
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

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 Intervention
Diskectomy
Intervertebral Disk Displacement
Device: Activ C disc prosthesis
Procedure: Anterior cervical discectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Order of movement [ Time Frame: baseline, 3 months, 12 months ] [ Designated as safety issue: No ]
  • Segmental mobility [ Time Frame: Baseline, 3 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment of symptoms (pain, neurological assessment) [ Time Frame: Baseline, 3 months, 12 months ] [ Designated as safety issue: No ]
  • Influence on subjects functioning (social, work) [ Time Frame: Baseline, 3 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2007
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868335

Contacts
Contact: H van Santbrink, MD, PhD +31 43 3875001 H.van.Santbrink@mumc.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: T Boselie, MD    +31 43 3874041    T.Boselie@mumc.nl   
Sub-Investigator: T Boselie, MD         
Sponsors and Collaborators
Maastricht University Medical Center
B. Braun/Aesculap Spine
Investigators
Principal Investigator: H van Santbrink, MD, PhD Department of Neurosurgery, Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: H. van Santbrink, MD, PhD, Neurosurgeon., Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00868335     History of Changes
Other Study ID Numbers: CWK-Tracking01
Study First Received: March 23, 2009
Last Updated: April 13, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:
Cervical degenerative disc disease
Anterior cervical discectomy
Cervical disc prosthesis
Activ-C
Mobility
Movement

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 27, 2014