Orthotics: New Ideas

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By Judith Philipps Otto

The Bellacure Osteoarthritis Treatment Device is one of those ideal solutions that make us wonder why someone didn't think of it years ago. 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.

Bellacure refers to it 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.

Mike Cannon, executive vice president-sales & marketing for Bellacure Inc., Seattle, Washington, said the new product was developed in response to surveys of patients and practitioners to determine what they disliked about available orthotic products, and what would have to go into the design of a device that would encourage patient compliance.

"We needed a simplified device that was easy to don and easy to apply with respect to how the forces were delivered to unload a patient's knee," explained Cannon. "Patients don't like a lot of straps and hard shells that make braces really uncomfortable to wear."

Since many patients have poor hand dexterity, an electromechanical dosing system was developed to allow accurate and repeatable application of the appropriate level of pain-relieving forces, by setting a simple dial. This dial-up dosing technology is the first of its kind in the O&P marketplace. A further benefit of the dosimeter is the associated forced feedback system that tells the practitioner how much unloading force is being generated and delivered to the patient's knee.

The computer chip technology that is incorporated into the treatment device includes LED indicators that warn the patient if they dial in too much force. A force sensor in the computer tells the patient when they've dialed in 50 lb. of torsional decompression, and continues to measure forces up to 150 torsional lb. of decompression.

 "We developed a three-point pressure unloading system that is very user-friendly, and also very comfortable, so we could ensure that the patient would actually want to wear this treatment device," Cannon said. "We also felt the need to really bring the technology up to [today's] standards. That meant creating garment structures that were abrasion-resistant, stretchable, had a long lifespan, and were comfortable for the patient."

Also new in the Bellacure brace is a cabling mechanism that is applied across soft dampening beds of material. "The patient does not feel all that force," said Cannon. "What they feel is the pain relief."

In addition, a 60-percent stretch textile that is lightweight and breathable incorporates impressive stretch memory for a secure and repeatable fit. The incorporated cabling mechanism allows the device to bio-comform to the patient's anatomy straight out of the box.

The device includes only one strap, which is adjusted during the initial fitting; once set, it provides stable alignment of the internal support shells, and never needs readjusting. Its structure allows direct biomechanical matching to each patient.

Introduced in August 2005, the Bellacure OA Treatment Device has an estimated 1,000 satisfied customers, and it continues to sell vigorously, Cannon said. "Our guarantee says that if patients don't get pain relief in 30 days, we'll refund the product price. So far, not a single unit has been returned because a patient did not receive adequate or full pain relief as a result of wearing the product."

Bellacure is committed to constantly reevaluating design improvements, and keeps a close eye on outcomes studies, said Cannon. "Are patients getting sustained practical pain relief? Is it facilitating their ability to restore their lifestyle to what it was before they had a debilitating injury or an osteoarthritic condition? We consistently examine and monitor this information. We will be moving forward with much more advanced studies related to the Bellacure treatment device. We will never stop recreating or advancing the technology for our O&P professionals out there, to ensure that they get a much better outcome for their patient than what is available on the market at this point."

For more information, call 206.762.3609 or 800.795.2070, e-mail mcannon@bellacure.com, or visit www.bellacure.com

Propioceptive Ankle Orthosis

Also on the orthotics horizon is a proprioceptive ankle orthosis from Stanford University. The university's Biodesign Innovation Program fosters problem-solving through creative inventiveness. The program recognizes excellence in biodesign innovation with annual awards. The 2005 Silver Award was accepted by a Stanford Biodesign Innovation Program Team including graduate engineering students Buzzy Bonneau, Jeremy Dittmer, Surag Mantri, Ryan McDonell, Tim Ramsey, and Tejas Mazmudar for "A Device to Prevent Falls in the Elderly."

With aging comes decreased proprioception, past studies reveal--and a subsequent increase in falls and resulting injuries. Stanford's innovators have equipped an ankle orthosis with a "smart chip" that is both sensitive and vigilant. It continuously monitors ankle roll and warns the wearer to compensate for a greater-than-normal roll by issuing a correctional vibration. The wearer is thus enabled to shift balance or change position to prevent the potential fall.

Research and testing continue before the brace can be made commercially available.