Clinical Information; Clinical Data Summary; Adjunct Clinical Trial - Orthofix 5212 Manual De Instrucciones

Clinical Information

Adjunct Clinical Trial

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