Orthofix SS-5212, Instruction Manual

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100
80
60
40
20
0
92%
68%
% Patients Fused
Active Placebo
Adjunct Clinical Trial: Overall Success Rate
Consistent users (n=64) of the device in this phase had an initial success
rate of 92.2% with a success rate of 70% after four years (a 24% reduction).
Inconsistent users (n=34) and the entire placebo group (n=97) had an
initial success rate of 65% with a success rate of 50% after four years (again,
a 24% reduction). Long-term follow-up data indicates the success rate
differentials between active and placebo units are maintained over time.
Long-term, consistent Spinal-Stim users benefit with a 40% increase in fusion
success, when compared to inconsistent and placebo device users. Based
on this analysis, the reduction in long-term success rates appears unrelated
to treatment with the Spinal-Stim. During this four year period, 10% of the
original patients in the randomized double-masked phase were lost to
follow-up and are not reflected in these success rates.
Failed Fusion Clinical Trial
Spinal-Stim was also tested for nonoperative salvage in patients presenting
with established pseudarthrosis of lumbar fusion in an open trial. Without
additional regrafting of fusion surgery, 67% of these cases reached a
successful fusion with consistent (an average of at least 2 hours per day)
PEMF treatment.
2
Spinal-Stim reduced smoking and multi-level fusion as risk factors in failed
fusion patients. Consistent users showed a 67.2% success rate in non-smokers
and a slightly lower 66.7% success rate in smokers. Users with failed single
level fusions showed a 68% success rate and a slightly lower 66% success
rate for failed multi-level fusions.