Clinical trial NCT00868335: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diskectomy
Intervertebral Disk Displacement
Keywords: Cervical degenerative disc disease
Anterior cervical discectomy
Cervical disc prosthesis
Activ-C
Mobility
Movement
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: B. Braun/Aesculap Spine
First posted: 2009-03-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Order of movement
timeFrame: baseline, 3 months, 12 months
measure: Segmental mobility
timeFrame: Baseline, 3 months, 12 months
Secondary outcomes:
measure: Treatment of symptoms (pain, neurological assessment)
timeFrame: Baseline, 3 months, 12 months
measure: Influence on subjects functioning (social, work)
timeFrame: Baseline, 3 months, 12 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Department of Neurosurgery, Maastricht University Medical Center
name: H van Santbrink, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.