Clinical Information; Adjunct Clinical Trial - Orthofix SPINALSTIM 5212CM Manual De Instrucciones

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.
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
• 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 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).
Patients consistently using placebo (inactive) devices
1,2
• Vertebral level
• Smoking
• Age
Adjunct Clinical Trial: Overall Success Rate
100
92%
80
60
40
20
0
Active
68%
Placebo
14