Orthofix AccelStim Manual De Instrucciones página 32

cases healed within 5.5 months when treated with the combination of low-intensity
pulsed ultrasound and intramedullary fracture nailing.
Acceleration of Conservatively Treated Fresh Distal Radius Fractures
Study Design
Placebo-controlled, randomized, double-blind multi-center study with the
prospectively defined primary end-point of a combination of clinical and radiographic
healing (4 out of 4 cortices bridged as judged by the blinded principal investigator). Sixty
one fractures with conservatively treated cancellous radial fractures were randomized
into the EXOGEN treated and control groups (Kristiansen et al. ).
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Patient Population and Demographics
The demographics of the trial participants were comparable across treatment and
control groups with regard to age, sex, fracture characteristics, interval between
fracture and change to: treatment of fracture, and duration of follow-up. Race
and ethnicity of trial participants were not provided. Results of this study may not
necessarily be applicable to patients of all races and ethnicities.
Evaluation Schedule
Treatment was started within seven days of the fracture, and patients instructed to
use the device until the 10 week follow-up visit. Duration of immobilization in the cast
was determined by the site investigator. Patients were scheduled to return for follow-
up at 1, 2, 3, 4, 5, 6, 8, 10, 12 and 16 weeks.
Clinical Results
EXOGEN treatment accelerated healing by 38% (61±3.4 days in the active group versus
98±5.2 days in the control group; p<0.0001).
The effect of EXOGEN pulsed low-intensity ultrasound on fracture reduction during
healing was also assessed. The subset of fractures which were satisfactorily reduced
having presented with at least 10 degrees of negative volar angulation were analyzed.
The active group demonstrated significantly smaller loss of reduction compared to the
placebo group (p<0.01).
Acceleration of Conservatively Treated Fresh Tibial Fractures
Study Design
Placebo-controlled, randomized, double-blind multi-center study with the
prospectively defined primary endpoint of a combination of clinical and radiographic
healing (3 out of 4 cortices bridged as judged by the blinded principal investigator).
Sixty seven patients with conservatively treated closed or Grade I open, cortical
diaphyseal tibia fractures were randomized into the EXOGEN® (SAFHS® Model 2A)
treated and control groups (Heckman et al. ).
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