Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis
Primary Purpose
Diskectomy, Intervertebral Disk Displacement
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Activ C disc prosthesis
Anterior cervical discectomy
Sponsored by
About this trial
This is an interventional treatment trial for Diskectomy focused on measuring Cervical degenerative disc disease, Anterior cervical discectomy, Cervical disc prosthesis, Activ-C, Mobility, Movement
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
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Anterior cervical discectomy, no disc prosthesis
Anterior cervical discectomy, with disc prosthesis
Outcomes
Primary Outcome Measures
Order of movement
Segmental mobility
Secondary Outcome Measures
Treatment of symptoms (pain, neurological assessment)
Influence on subjects functioning (social, work)
Full Information
NCT ID
NCT00868335
First Posted
March 23, 2009
Last Updated
March 20, 2016
Sponsor
Maastricht University Medical Center
Collaborators
B. Braun/Aesculap Spine
1. Study Identification
Unique Protocol Identification Number
NCT00868335
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center
Collaborators
B. Braun/Aesculap Spine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diskectomy, Intervertebral Disk Displacement
Keywords
Cervical degenerative disc disease, Anterior cervical discectomy, Cervical disc prosthesis, Activ-C, Mobility, Movement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Anterior cervical discectomy, no disc prosthesis
Arm Title
2
Arm Type
Experimental
Arm Description
Anterior cervical discectomy, with disc prosthesis
Intervention Type
Device
Intervention Name(s)
Activ C disc prosthesis
Other Intervention Name(s)
Activ C cervical disc prosthesis, B.Braun/Aesculap Spine
Intervention Description
cervical disc prosthesis
Intervention Type
Procedure
Intervention Name(s)
Anterior cervical discectomy
Intervention Description
Removal of protruding cervical disc through an anterior approach
Primary Outcome Measure Information:
Title
Order of movement
Time Frame
baseline, 3 months, 12 months
Title
Segmental mobility
Time Frame
Baseline, 3 months, 12 months
Secondary Outcome Measure Information:
Title
Treatment of symptoms (pain, neurological assessment)
Time Frame
Baseline, 3 months, 12 months
Title
Influence on subjects functioning (social, work)
Time Frame
Baseline, 3 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H van Santbrink, MD, PhD
Organizational Affiliation
Department of Neurosurgery, Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
25887569
Citation
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.
Results Reference
derived
Learn more about this trial
Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without a Cervical Disc Prosthesis
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