Clinical Information; Clinical Data Summary - Orthofix CERVICALSTIM 5505CE Manuel D'instructions

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