Orthofix Cervical-Stim 2505 Patient Manual página 18

One hundred and twelve (112) patients reported a total of 157 adverse
(negative) effects for both groups combined at six months after surgery.
There was no significant (meaningful) difference in the total number of adverse
events or the number of patients reporting effects in the control group and
the Cervical-Stim group nor in the numbers of patients in each group who
experienced an adverse event. The adverse effects that may be experienced
include: increased pain, numbness and tingling, headache, migraines and nausea.
These effects may or may not be directly related to the use of the Cervical-Stim.
Clinical success with regard to symptoms was evaluated by the following:
• no worsening in neurological function
• an improvement in pain
• no worsening in Neck Disability Index
Based on the criteria above, there was no major difference between the
control group and the Cervical-Stim group in clinical success. An equal number
of patients in both groups showed an improvement in their clinical condition
after surgery, regardless of treatment.
Long-term x-ray information collected at 11 months after surgery or later
showed no meaningful difference in fusion rate between the Cervical-Stim
treatment group and the control group who received rountine care alone.
The results of this study show that the use of the Cervical-Stim is both safe
and effective in increasing the frequency of fusion by six months after surgery
in high-risk subjects having cervical fusion.
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