The primary goal of this study to investigate the long term functional and radiological outcome of those patients that underwent a cervical laminectomy in the treatment of a cervical spondylotic myelopathy.The secondary goal is to determine those…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter is the functionality of the patient that is
established by scoring this functionality on several different validated
scales. For the group as a whole, including those patients who are lost to
follow up, the scales will be the Odom and the Likert scale.
For those patients in whom follow up study is possible, the outcome will be
established with a combination of the Odom and Likert scale, the Nurick score,
the adjusted Japanese Orthopedic Association (JOA) score, the Cooper Myelopathy
Scale (CMS), the European Myelopathy Score (EMS) and the Myelopathy Disability
Index (MDI).
Another primary outcome parameter is the presence of kyphosis of the cervical
spine, which will be determined by comparing the pre- and postoperative X-ray
of the cervical spine using the Batzdorf classification and the Matsumoto
method. Not only the presence of kyphosis, but also the degree of kyphosis will
be measured.
Secondary outcome
A secundary outcome parameter is the instability of the cervical spine after a
cervical laminectomy. Instability will be measured on functionality X-rays of
the cervical spine on the follow up visit of the patient. Instability will be
determined by considering the alignment of the posterior borders of the
corpora.
Background summary
Degenerative changes of the cervical spine often result in clinical symptoms,
like for instance neurological deficits, because these degenerative changes
result in compression of the spinal cord. In earlier years, a wait-and-see
policy was generally advocated. If eventually a decompression was inevitable
the posterior approach was chosen. In the eighties an anterior approach became
more popular, even for a decompression of more than one level. However, an
anterior discectomy of more levels implies at least one corporectomy and thus a
surgical procedure including a spondylodesis. This leads to loss of mobility of
the cervical spine. Moreover, the patient wears a stiff collar for several
months, which many patients consider uncomfortable. Finally, the risk of
dysphagia and dysphonia is considerable in anterior decompressive surgical
procedures involving corporectomies.
In daily practice, satisfying results are accomplished using the posterior
approach to decompress the cervical spinal cord. In current publications
though, this approach is considered to be outdated, since it would lead to
kyphosis and instability of the cervical spine. This would ultimately lead to
new or recurrent clinical symptoms of spinal cord compression.
It is however insufficiently examined whether a cervical laminectomy indeed
results in kyphosis and instability and it was never investigated whether and
to which extent kyphosis and/or instability cause clinical symptoms. Therefore
a study that studies these aspects is deemed necessary.
Study objective
The primary goal of this study to investigate the long term functional and
radiological outcome of those patients that underwent a cervical laminectomy in
the treatment of a cervical spondylotic myelopathy.
The secondary goal is to determine those factors that have a significant
influence on 1) deterioration in functionality and 2) kyphosis of the cervical
spine after a cervical laminectomy.
Study design
A retrospective patient file investigation in those patients that had a
cervical laminectomy between 1994 and 2005 in combination with a follow up
evaluation (both anamnestic and radiological) of the current situation of those
same patients
Study burden and risks
The patient has to come to the hospital only one time to fill in questionnaires
and on this same day three X-rays of the cervical spine will be made.
Albinusdreef 2
2333 ZA Leiden
Nederland
Albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
Inclusion criteria
cervical laminectomy between 1994-2005
clinical symptoms correspond with a cervical myelopathie
informed consent
Exclusion criteria
no MRI and x-CWK before surgery
has had any additional surgery of the cervical spine
no follow-up after surgery
Design
Recruitment
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 |
|---|---|
| CCMO | NL27566.058.09 |