Orthofix Inc OFIX-5000-001 Manual De Usuario
13
Clinical Information
Clinical Data Summary
Spinal-Stim was studied in human clinical trials to evaluate its safety and
effectiveness as a therapy added to standard post-surgical care (referred to as
the “adjunct clinical trial”). A separate phase of the clinical trial (referred to as
the “failed fusion clinical trial”) examined patients with fusions that had not
healed (pseudarthrosis) after a lumbar fusion surgery. The patients in both
clinical studies had risk factors.
Adjunct Clinical Trial
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.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:
At one year after the fusion surgery, patients using active devices on a
consistent daily regimen (an average of at least two hours per day) developed
solid fusion in 92% of the cases. Patients consistently using placebo devices
developed solid fusion in 68% of the cases.
Spinal-Stim was studied in human clinical trials to evaluate its safety and
effectiveness as a therapy added to standard post-surgical care (referred to as
the “adjunct clinical trial”). A separate phase of the clinical trial (referred to as
the “failed fusion clinical trial”) examined patients with fusions that had not
healed (pseudarthrosis) after a lumbar fusion surgery. The patients in both
clinical studies had risk factors.
Adjunct Clinical Trial
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.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:
At one year after the fusion surgery, patients using active devices on a
consistent daily regimen (an average of at least two hours per day) developed
solid fusion in 92% of the cases. Patients consistently using placebo devices
developed solid fusion in 68% of the cases.
• Number of levels
• Vertebral level
• Graft type
• Smoking
• Internal fixation
• Age
• 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
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).
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).