Orthofix AccelStim Manual De Instrucciones página 33

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 treatment of fracture, duration of follow-up, and days to start weight-
bearing. 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 continued for 20 weeks
or until the clinical investigator judged the fracture to have healed. All patients were
scheduled for follow-up radiographs at 4, 6, 8, 10, 12, 14, 20, 33 and 52 weeks after
the fracture. Clinical follow-up evaluations were performed at the time of any cast
change (usually at 6 and 10 weeks) and at the follow-up visit when radiographic
evaluation indicated the fracture had healed sufficiently to allow removal of the cast.
Clinical Results
EXOGEN treatment induced a 38% acceleration in achieving the prospectively defined
primary endpoint of a combination of clinical and radiographic healing (96±4.9 days in
the active group versus 154±13.7 days in the control group; p = 0.0001).
Analysis of Fresh Fracture Studies
1
Cook et al. retrospectively studied the tibial and distal radius fracture data of Heckman
et al. and Kristansen et al. to analyze the impact of low-intensity pulsed ultrasound
9 10
on the incidence of delayed unions, and on the healing time of smokers. Significant
reductions in time to healing of tibial shaft fractures were observed in the active
ultrasound treatment group with casting versus the casting only placebo control group
(a 41% reduction for those who smoked, p<0.006; a 26% reduction for nonsmokers,
p<0.05). Similarly, the distal radius fractures treated with the ultrasound device also
showed decreases in healing time compared to placebo control group (51% faster
active healing rate in smokers, p<0.003; 34% faster active healing in nonsmokers,
p<0.0001).
Heckman et al. reported similar results in a group of tibial fractures treated with the
9
ultrasound device as compared to placebo control. There was a statistically significant
decrease in the time to clinical healing (86 +/- 5 days vs. 114 +/- 10.4 days, p=0.01)
and also a significant decrease in the time to overall clinical and radiographic healing
(96 +/- 4.9 days vs. 154 +/- 13.7 days, p=0.0001).
32