Clinical Study Summary - VQ OrthoCare BioniCare Manual De Instructiones

BioniCare ® Hand System

Clinical Study Summary

The study was designed as a prospective, multi center, open-label study
to evaluate the efficacy and safety of the BioniCare Hand System in the
treatment of Osteoarthritis of the hand. Patients were entered from the
investigating physician's practice, without advertising, if they were 18 years
or older, had osteoarthritis of the hand that was symptomatic for at least
3 months with a pain score of at least 3 out of 10 on a VAS scale despite
stable NSAIDs and/or analgesics for at least a month prior to study entry.
Eighty two patients were enrolled, 66 females and 16 males, with a mean
age of 64 and a range of 45 to 89 years. When both hands were affected
the more symptomatic hand was designated the index hand to be treated.
The primary outcome measure was osteoarthritis pain in the last 48 hours.
Additional efficacy outcomes were pain in the study thumb in the last 48
hours, patient global assessment and the physicians' global assessment.
Efficacy assessment of function included the validated DASH functional
assessment questionnaire and the traditional measures of strength, pinch
force and grip strength as measured by a JAMAR Hand Assessment Kit
which includes a squeeze (grip) dynamometer and a pinch dynamometer.
Efficacy was expressed for each variable as the effect size. Effect sizes are
generally recognized to be small if they are from 0.2 to 0.49, moderate
from 0.5 to 0.99 and large if they are 1.0 or greater.
In the intent-to-treat statistical analysis, after 8 weeks of treatment, the
effect size for OA pain in the study hand in the past 48 hours was 1.3,
for OA pain in the study thumb for the past 48 hours was 0.8, for patient
global assessment was 1.2, and for physician global assessment was 1.1.
Functional outcome was moderately improved by the DASH Score with
an effect size of 0.5. Smaller but still significant effect sizes were seen
for the additional functional outcomes of pinch force, effect size 0.4 and
grip strength with an effect size of 0.3. A limitation of this trial is that it
was an open label study which includes the likelihood of bias caused by
placebo effect. This was partially compensated by maintaining patients
on stable NSAIDs and/or analgesics for the month prior to and for the
entire study. This makes it more difficult to show efficacy as the benefit
must be in addition to that of NSAIDs and/or analgesics. For example
metaanalytic studies have shown an effect size for acetaminophen of
0.21 (95% confidence interval 0.02 to 0.41) and an effect size for NSAIDs
of 0.32 (0.24 to 0.39). It should be noted that these effect sizes were in
comparison to placebo. However, it should also be noted that all of the
trials required discontinuation of previous pharmacotherapy for 3 to 14
days prior to study entry. The majority of trials additionally required a pre-
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