Orthofix SpinalStim 5212, Инструкция по эксплуатации

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Clinical Information
Adjunct Clinical Trial
The SpinalStim device 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. The SpinalStim device 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.
1
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:
• Number of levels • Vertebral level
• Graft type • Smoking
• Internal fixation • Age
• Gender
100
80
60
40
20
0
92%
68%
% Patients Fused
Active Placebo
Adjunct Clinical Trial: Overall Success Rate
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
SpinalStim device 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).