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

• ClinicalTrials.gov Identifier: NCT00868335
• Recruitment Status: Completed
• First Posted: March 24, 2009
• Last Update Posted: March 22, 2016
• Sponsor: Maastricht University Medical Center
• Collaborator: B. Braun/Aesculap Spine
• Information provided by (Responsible Party): Toon Boselie, Maastricht University Medical Center

Tracking Information

• First Submitted Date: March 23, 2009
• First Posted Date: March 24, 2009
• Last Update Posted Date: March 22, 2016
• Study Start Date: December 2007
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Diskectomy
• Intervertebral Disk Displacement

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 23, 2009): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2015
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00868335
• Other Study ID Numbers: CWK-Tracking01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Toon Boselie, Maastricht University Medical Center
• Study Sponsor: Maastricht University Medical Center
• Collaborators: B. Braun/Aesculap Spine

Investigators

• Principal Investigator: H van Santbrink, MD, PhD; Department of Neurosurgery, Maastricht University Medical Center

• PRS Account: Maastricht University Medical Center
• Verification Date: March 2016