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

Sponsors and Collaborators:	Maastricht University Medical Center B. Braun/Aesculap Spine
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00868335

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

MedlinePlus related topics: Herniated Disk Neck Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Cervical Spine; Movement Before and After Anterior Cervical Discectomy, With or Without an Activ-C Cervical Disc Prosthesis.

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
1: Active Comparator Anterior cervical discectomy, no disc prosthesis	Procedure: Anterior cervical discectomy Removal of protruding cervical disc through an anterior approach
2: Experimental Anterior cervical discectomy, with disc prosthesis	Device: Activ C disc prosthesis cervical disc prosthesis 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

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, Limburg
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:	Maastricht University Medical Center ( H. van Santbrink, MD, PhD, Neurosurgeon. )
Study ID Numbers:	CWK-Tracking01
Study First Received:	March 23, 2009
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00868335 History of Changes
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

Study placed in the following topic categories:

Spinal Diseases
Musculoskeletal Diseases
Intervertebral Disk Displacement
Bone Diseases

Additional relevant MeSH terms:

Spinal Diseases
Musculoskeletal Diseases
Intervertebral Disk Displacement
Bone Diseases

ClinicalTrials.gov processed this record on May 07, 2009