The Bellacure Treatment Device—Revisited
By Judith Philipps Otto When a new orthotic contender appears on the market
from nowhere, and its claims appear almost too good to be true, a
dubious world naturally clamors for
outcomes--documentation--quantitative evidence one can take to the
bank.
Unfortunately, as many previous clinical studies by O&P
researchers have discovered, the multitude of factors that may
influence the relative success of patients utilizing a particular
specimen of prosthetic or orthotic technology are so diverse and
individual to each case as to make valid outcomes studies a
daunting challenge.
Across the board, however, recognizing the growing need for more
specific substantiation of O&P devices' vague claims to "help"
patients, we are making progress in developing measurement systems
that stand up to scrutiny.
The worst enemy of any new technology is, ironically, its very
novelty. Studies with any claim to validity take time to complete.
Before-and-after comparisons cannot be made unless and until we
have a reasonable amount of time between the "before" and the
"after"; the evolution of developing improvement cannot be measured
without allowing reasonable time for measurable degrees of
evolution to take place.
The recently introduced Bellacure Osteoarthritis Treatment
Device is in the unenviable position of being such an unproven new
product. As previously described, this unique orthosis not only
relieves pain, but is simple to don, requires no readjustment after
the first donning, is comfortable to wear, and cosmetically more
appealing than most braces.
It is referred to as a "treatment device" rather than a brace,
because it includes a revolutionary built-in dosing mechanism that
allows the patient to dial in the correct amount of decompressing
force to the arthritic compartment of the patient's knee. The pain
relief level is sensed and displayed electronically, allowing
patients to accurately reproduce the physician's prescription for
pain relief.
Thus far, documentation has not been offered, although the
device reportedly continues to be fitted to an increasing number of
satisfied customers.
Yet, even while pointing out that barely six months' worth of
sales and distribution of the Bellacure device hardly offers
sufficient fodder for study, Mike Cannon, executive vice
president-sales & marketing for Bellacure Inc., is far from
offering apologies or excuses.
Instead, he points to existing studies that support the basic
design of his product and the rationale behind the improvements
that have made it so popular with orthotists and patients alike,
earning endorsements from one and compliance from the other.
"Basically," says Cannon, "every study that's been done to prove
the efficacy of a three-point force design is directly applicable
to our product."
The three-point design is the most studied in the history of
bracing with regard to unloading capabilities, he points out,
citing research that supports the conclusion that three-point force
is more efficient and delivers a greater amount of decompression
than other available systems. Such studies include those done by
Horlick and Loomer, Matsuno, Katsuragawa, S. Kirkley, F. Polo, and
T. Wickiewicz and R. Warren.
"What we have done differently with the three-point force design
is to make it far more efficient in its delivery, and far more
comfortable in the way that it wears. The increased efficiency
allows it to deliver a greater capacity for unloading the knee
compartment than anything else currently available.
"That doesn't mean that we're not looking for more studies," he
is quick to add. "As a matter of fact, we've been approached by
multiple entities with respect to pursuing studies, and we are
currently moving forward with those."
Bellacure is committed to focusing on outcomes studies, says
Cannon, "but in order to gain real knowledge you have to be out
there for a long period of time. That is certainly our
intention."
Unlike Athena, Cannon's device did not spring from its creator's
head fully mature and armored for battle.
"It was based not only upon a lot of prior research, but also
upon extensive mathematical formulations and calculations which
gave us the ability to look at three-point pressure designs and
actually make something that was much more efficient. We developed
the appropriate engineering data, the force diagrams--it took time,
careful study, and some inventive problem-solving."
Things are coming together as the product's longevity grows,
however, and within one to five years, Cannon expects to be able to
provide a continuous flow of both analytical data and solid
clinical information as it becomes available through the
researchers currently at work.
"There are not enough studies being done in the O&P industry
on functional outcomes for patients," Cannon said. "We know that
there are a lot of very solid large facilities and even smaller
facilities that would be willing and able to handle some very basic
studies concerning outcomes on patients in the Bellacure treatment
device, and we welcome any inquiries.
"There is such a wealth of talent and knowledge from our
professionals in the O&P industry that it's a bit disturbing to
me that more orthopedic companies are not seeking their knowledge
and doing studies with our O&P professionals," says Cannon. "I
find that very discouraging, and I would love the opportunity to do
more studies with them."
If growing popularity is any measure of success, Bellacure's
sales figures constitute a ringing endorsement: Within the last
three months, sales have quintupled from the 1,000 devices in use
recently reported, based on end-of-January figures.
Cannon expects more high-profile professional athletes to soon
join the several who are already numbered among his clientele.
(While San Francisco Giants left fielder Barry Bonds has not yet
confirmed that he actually wears a Bellacure treatment device, the
press has stated that he does. Note: Watch ESPN on April 4 for more
information.)
The best test of success is ultimately time; in Bellacure's
case, as in all others, time will tell.
For more information on the Bellacure device, visit www.oandp.com/edge/issues/articles/2006-03_15.asp
Valgus Knee Bracing for Medial Gonarthrosis
Simon G. Horlick, B.Sc., MD
Richard L. Loomer, B.A., MD
Clinical Journal of Sports Medicine
3:251-255 1993
Kinematics of Valgus Bracing for Medial Gonarthrosis: Technical
report
Peter L. Davidson
David J. Sanderson
Richard L. Loomer
Clinical Biomechanics 13 (1998) 414-419
Change of Bone Mineral Density with Valgus Knee Bracing
Y. Katsuragawa
N. Fukai
K. Nakamura
Journal of International Orthopedics (1999) SICOT
The Effect of Bracing on Varus Gonarthrosis
A. Kirkley MD
S. Webster-Bogaert M.SC
R. Litchfield MD
A. Amendola MD
S. Macdonald MD
R. McCalden MD
P. Fowler MD
Volume 81-A No 4 April 1999
The Journal of Bone and Joint Medicine
The Increasing Need for Nonoperative Treatment of Patients with
Osteoarthritis
Joseph Buckwalter MD
William D. Stanish MD
Randy N. Rosier MD, PhD
Robert C. Schenck Jr., MD
Douglas A. Dennis MD
Richard D. Coutts MD
Clinical Orthopaedics and Related Research
April 2001 #385 38-45
Lippincott Williams and Wilkins, Inc.
Reducing Compartment Loads with Valgus Bracing in The
Osteoarthritic Knee
Fabian E. Pollo Ph.D.
James C. Otis Ph. D
Sherry I. Backus M.A., P.T.
Russell F. Warren M.D.
Thomas L. Wickiewicz M.D.
American Orthopedic Society for Sports Medicine
June 28-July 1, 2001 
Table Of Contents - April 2006
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