Objective of the study is to verify whether the movement pattern after anterior cervical discectomy normalises, in case of implantation of a cervical disc prosthesis.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Spinal cord and nerve root disorders
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Movement testing of the cervical vertebral column in both groups according the
given methods. Comparing both investigational arms, defined to normal values.
Secondary outcome
Clinical condition of the different patients groups according the used
outcome/scoring scales
Background summary
Standard treatment for cervical radicular syndrome based on a cervical disc
protrusion is anterior cervical discectomy with or without intended fusion. In
case fusion is not intended, in 70% of the cases the operated level will fuse
spontaneously. The movement of the cervical vertebral column will change after
anterior cervical discectomy. The pressure in the intervertebral disc above or
below the operated level will increase, which leads to an increased
degeneration of these intervertebral disc levels. Artificial disc implants are
developed to prevent this increased degeneration by restoring the anatomy and
functionality of the operated level. Studies showed that a disc implant allows
flexion and deflexion but whether this is a natural movement pattern is
unclear. The underlying protocol intends to investigate the movement pattern
after implantation of a cervical disc implant. A natural movement pattern is an
obligatory condition to prevent increased degeneration in the adjacent levels.
Study objective
Objective of the study is to verify whether the movement pattern after anterior
cervical discectomy normalises, in case of implantation of a cervical disc
prosthesis.
Study design
Open randomised trial. The control group consists of patients who receive a
standard treatment, simple anterior cervical discectomy. The study group
consists of patients who receive the standard treatment with additional
implantation of a cervical disc prosthesis.
The reference values will be established on the basis of a historical control
group and an also analyzed group of healthy subjects.
Intervention
Anterior cervical discectomy (standard treatment option) in the control group,
additional impantation after discectomy of a disc prosthesis in the
investigational group.
Study burden and risks
The study requires three times fluoroscopy of the cervical vertebral column to
investigate movement (0.1 mSv /study), which takes several minutes. Besides the
patient is asked to fill out scoring forms which will take 15 to 20 minutes a
time. There will also be a short fysical examination, which takes about 5
minutes. These activities are planned in succession to each other so the total
time spent on filling out the questionairres and the examinations is about 30
minutes.
The literature reports no additional operation related risks of implantation of
an cervical disc prosthesis. Main reported implant failure is fusion, which
will happen in simple anterior cervical discectomy in 70% of the cases.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Studygroups:
Clinical moniradicular syndrome C6 or C7
age between 18 and 55
Monosegmental abnormality on MRI
Able to perform flexion and extension movement by the patient self
Segmental Range of Motion (ROM) > 2 degrees
Willingness to Follow up
Informed consent;Control-group:
Age 18-55
Subject is able to actively perform flexion and extension movement
Informed consent
Anamnestic and based on the neck disability index no neck complaints (NDI <5)
Exclusion criteria
-Cervical spinal surgery in history
-Degenerative spinal deformities on multiple levels
-Positive sign of L'Hermitte
-Active infection
-Immature bone
-Cervical spine tumor
-Radiotherapy in history
-Pregnancy
-Cervical myelopathy
-Not able to speak and understand the Dutch language;Control-group:
-Cervical spinal surgery in history
-X-ray imaging of head/cervical spine/thorax in the previous year
-Degenerative spinal deformities (vertebral bodies or zygapophysial joints)
-Positive sign of L'Hermitte
-Active infection
-Immature bone
-Cervical spine tumor
-Radiotherapy in history
-Pregnancy
-Cervical myelopathy
-Not able to speak and understand the Dutch language
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00868335 |
| CCMO | NL14240.068.06 |