Clinical Data Summary - Orthofix Cervical-Stim 2505 Patient Manual

Clinical Data Summary

The Cervical-Stim was studied in humans to evaluate its safety and effectiveness
as a therapy added to routine care (adjunct therapy) for high-risk patients having
a cervical fusion surgery for degenerative conditions. Patients were high-risk if
they were a smoker (one pack per day or more) and/or had a multi-level fusion
surgery (more than one level).
The 323 patients were randomly assigned, similar to a coin toss, to one of two
groups: either the control group (routine care only) or the treatment group
(Cervical-Stim + routine care). One hundred and sixty (160) patients were
assigned to the control group and 163 patients were assigned to the
Cervical-Stim group. Patients wore the Cervical-Stim unit for 4 hours each day
either for 4 continuous hours or in one hour sessions.
Safety and effectiveness was evaluated by measuring the following:
• rate and severity of adverse events
• rate of cervical fusion by six months after surgery as determined by x-ray
Eighty-four percent (84%) of the Cervical-Stim group were fused by six months
(102/122 patients) versus only 69% of the control group (81/118 patients). This
is a 15% difference between these two groups and is statistically significant
(meaningful); p=0.0065. That is, more patients fused in the Cervical-Stim group
than in the control group.
The rate of patients who came back for their six month examinations and
x-rays was 74% for the Cervical-Stim 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.
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