Clinical Information; Clinical Data Summary - Orthofix CervicalStim 5505CE Bedienungsanleitung

Clinical Information

Clinical Data Summary

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