Orthofix CERVICAL STIM 5505CE, Instruction Manual

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11
The rate of patients who came back for their six month examinations and
x-rays was 74% for the CervicalStim group and 73% for the control group.
Patients who did not come back for scheduled examinations could not be
evaluated; thus their success or failure is not known. These unavailable data
could have a positive or negative effect on the overall success of this study.
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 CervicalStim 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
CervicalStim.
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 CervicalStim 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 CervicalStim
treatment group and the control group who received rountine care alone.
The results of this study show that the use of the CervicalStim is both safe and
effective in increasing the frequency of fusion by six months after surgery in
high-risk subjects having cervical fusion.