Does size matter? Clinical outcome related to the extent of posterior (cranio)cervical fixations. A prospective international multicenter study.

Degenerative disease is the most common indication for cervical fixation, as it
is the most common cause of myelopathy and radiculopathy, causing progressive
functional disability and impairment.
In general, there is an indication for surgery when there is neurological
deficit or pain and lack of response to conservative treatment, spinal cord
compression with significant neurologic deterioration, mechanical instability,
or substantial cervical vertebral deformity. There are several indications for
posterior cervical instrumented spondylodesis, i.e. fixation. In most cases,
the spondylodesis is done secondary to decompression of the dural sac and/or a
spinal root(s). In other instances, spondylodesis is performed to prevent
compression of neural structures. The surgical technique and the extent of the
fixation are currently based on patient related factors, such as age,
comorbidity and antomy, and the preference of the traeting surgeon based on his
expertise and experience with the procedure.

A study on extent-related outcome and complications for degenerative cervical
spinal disease has not yet been performed. Results of this study may form the
basis for a guideline regarding the extent of fixation in degenerative cervical
spinal disease. Furthermore, analysis of the influence of patient related
factors on the clinical outcome and rate of complications will be informative
for the treating surgeon.

This study is a prospective, international, muticenter study to assess the
clinical outcome of posterior (cranio)cervical fixations, differentiated
according to the extent of the surgery. During the inclusion period of one
year, all posterior (cranio)cervical fixations of patients who meet the
inclusion criteria and heave given written informed consent to participate in
this study, will be registered in a secured database. Baseline (preoperative)
and perioperative data will be registered. During the follow-up period ot two
years, all primary and secondary study parameters will be registered. At the
end of the study, which is defined as the last patient's last follow-up, data
analyses will be performed.

(cranio)cervical fixation

Participating in the study will not pose additional risks, because they will be
treated by usual care. Patients will be asked to complete questionnaires.