Clinical Information; Clinical Data Summary - Orthofix Cervical Stim 5505 Manual De Instrucciones

Clinical Information

Clinical Data Summary

The CervicalStim 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, to one of two groups: either the
control group (routine care only) or the treatment group (CervicalStim + routine
care). One hundred and sixty (160) patients were assigned to the control group
and 163 patients were assigned to the CervicalStim group. Patients wore the
CervicalStim 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 CervicalStim 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 CervicalStim group
than in the control group.
Clinical Trial: Overall Success Rate
100
84%
80
60
40
20
0
Treated
69%
Untreated
10