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
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Richard L. Loomer, B.A., MD
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William D. Stanish MD
Randy N. Rosier MD, PhD
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Richard D. Coutts MD
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April 2001 #385 38-45
Lippincott Williams and Wilkins, Inc.
Reducing Compartment Loads with Valgus Bracing in The
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Fabian E. Pollo Ph.D.
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American Orthopedic Society for Sports Medicine
June 28-July 1, 2001
