Clinical Data Summary - Orthofix SPINAL-Stim Manual De Instrucciones

Clinical Data Summary

Spinal-Stim has been tested in a clinical study involving 54 surgeons at 31 centers.
This clinical investigation contained a prospective randomized double-masked
trial of PEMF efficacy. Spinal-Stim was tested as a surgical adjunct in patients
undergoing a first attempt at lumbar fusion. At one year postoperative,
patients using active devices on a consistent daily regimen (an average of
at least two hours per day) developed solid fusion in 92.2% of the cases.
Patients consistently using placebo (inactive) devices developed solid fusion
in 67.9% of the cases. This 35% increase in treatment effect is statistically
significant, and is realized regardless of:
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Number of Levels
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Graft Type
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Internal Fixation
The success rate for patients in the randomized double-masked phase for
whom success or failure status is known at four years after treatment with the
Spinal-Stim for all subjects (consistent and inconsistent users combined) was
63% (n=88) as compared with 83% in this phase of the clinical trial (i.e., one
year postoperative). 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.
Spinal-Stim was also tested for nonoperative salvage in patients presenting
with established pseudarthrosis of lumbar fusion in an open trial. Without
concomitant regrafting, 67% of these cases reached a successful fusion with
consistent (an average of at least 2 hours per day) PEMF treatment.
The four year success rates for these patients in the open trial, non-operative
salvage phase for all subjects (consistent and inconsistent users combined) was
39% (n=119) as compared with 57% in this phase of the original clinical trial
(i.e., one year postoperative). Consistent users (n=93) of the device in this
phase had a success rate of 44% after four years. Inconsistent users (n=26)
of the device in this phase had a success rate of 19% after four years. The
reduction in success rates from the time of commercial marketing compared
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Gender
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Vertebral Level
11
1
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Smoking
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Age
2