Pre-Preg Carbon Dynamic Orthosis

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By Noel J. Chladek, CO

Have we found the evolution of lower-extremity orthotics? We pose a question to orthotic practitioners: "Are your patients benefiting completely from the devices you are designing for them?"

We may have been asking ourselves this question subliminally or directly for years. It may keep you up at night, or keep you occupied occasionally throughout the days of providing patient care. "Is this the best possible device to treat this patient's pathology?"

As orthotic practitioners, we may have invested years in training, education, and study of the newest technologies and applications to create an optimum rehabilitative device for our patients. As human beings, we want to know that our efforts are creating an improvement in the situation of the patients that we see. The reward, at the end of the day, is dependent on being able to answer our posed question with affirmation. This is our drive to attack each day and the challenges that lie ahead, building on the affirmation of the previous day's success.

Or are we fooling ourselves? If you take a moment and reflect on a recent fitting that went well, ask yourself: "Did that patient benefit from the device 100 percent?" Through honest reflection, the answer may not be 100-percent satisfactory treatment. We are willing to tolerate some dissatisfaction, even with overall success, if we are somehow limited by certain restrictions that are beyond our control, right?

We have posed this question to ourselves as well, and when limitations in the materials and technology failed us, we pushed back, and forced the technologies to meet the treatment standards that we desired. We used our drive to find and experiment with different materials and technologies that were available in different industries. We started frantically including them in our fabrication incessantly, many times ending in failure, although we never stopped searching. Our experimentation has taken us to levels that we had never dreamed possible on the outset of this journey.

Success after Effort

Our clinical practice uses a custom-molded, energy-storing, pre-impregnated carbon device for treatment of 60 percent of our lower-extremity orthosis fittings. We also experience a 90-percent successful first-time fitting rate with little adjustment necessary at fitting. Our patients exclaim their excitement and appreciation for being able to find a facility that understands their complex dilemma and has the answer to treating it. And we are still not satisfied--we will continue to push the standard of bracing in an ongoing attempt to reach orthotist nirvana.

What Is Dynamic Response?

Dynamic response is acquired when the forces acted upon the device from the patient's ambulatory force, are returned, in some form, to the gait cycle to increase the function of the deficient anatomy. The patient often describes the sensation as "having a spring in my step," and a feeling of "natural stability." The dynamic response is set by the practitioner to ensure that the device does not hinder the functioning portions of the limb, though increasing the function of the deficient anatomy.

Utilizing the addition of the new materials, we have found that by creating customized forces throughout the gait cycle, the patient is able to ambulate without a feeling of walking "flat," thus increasing the repetition rate before exhaustion.

With a history of orthosis designs that offer only rigid restriction of motion or free guidance of motion, the evolution we have created is true dynamic response. It allows motion and a gradient resistance throughout the entire stance phase.

Once you begin experimenting in the area of dynamic response, everything becomes much more detailed and complex during the initial evaluation of the patient. You must examine the patient's strengths and weaknesses in the musculature of the affected limb more precisely. Then it is necessary to build on the patient's strengths and replace or assist the areas that are lacking in strength.

You then need to use the information gathered from the evaluation to determine the resistance level that would be beneficial to the patient. Utilizing all the information gathered from the evaluation phase, you can designate then the proper position for casting to optimize the gradient force vector so that the gait cycle is smooth and free of evident transition.

As each orthosis in pre-impregnated composite fabrication is custom to the patient's model, the evaluation and modeling procedure is pivotal to ensure that the device will function effectively for the patient. A very slight alignment flaw could cause the creation of an orthosis that will not function for the patient. Working with such expensive materials, it was necessary for our department to remake hundreds of devices over the years of experimentation.

We have tested numerous composite materials and resin combinations to find the system that would ensure a strong bond within the materials and would tolerate the excessive force and also repetitious forces found in ambulation. The fabrication procedure must be precise regarding curing temperature, cure time, and outside elements, as these variables can cause failure in the device. Even the slightest miscalculation has ruined an entire development cycle of devices.

Appearance

The Dynamic Response Orthosis is aesthetically and functionally pleasing to the patient. Utilizing carbon fiber creates a much lighter device than the traditional orthosis, and the requirement for less material to achieve the necessary function ensures less overall brace for the patient. The orthosis can be made in any range of colors to match the patient's personality and preference.

Evaluation of Success

The simplest evaluation of the patient's success is found when evaluating the patient's stride length and the overall amount of time spent on the affected extremity. We often will view these attributes of the patient while wearing the new device and compare it directly to the previously worn device and anatomical ambulation.

Reimbursement

We currently fabricate our dynamic response orthosis design for several independent facilities across the country. These facilities have found little difficulty with obtaining the increased reimbursement to warrant the additional expense of fabrication of the dynamic response orthoses. In our patient care facility, we have noted a 40-percent increase in reimbursement for this device, which easily offsets the additional expense for fabrication.

Training

The utilization of the device is complex in nature, and a thorough training procedure is necessary. We have devised a hands-on training procedure for practitioners who are interested in providing dynamic response orthoses in their clinic. The class consists of a two-day workshop that will greatly reduce the amount of errors in evaluation and casting and create a complete understanding of the entire process.

Building on our successes has given us the drive to continue on this adventure optimistically. The many years and late nights of experimentation and frequent failure already have been invested, and more will be necessary in the future--this is certain. The financial burden of working with these expensive materials and the specialized equipment has been realized completely. At the end of this, though, we find that we have developed a bracing system that can most closely offer a satisfactory device for fitting to our patients.

We are terribly excited to be able to provide better treatment in lower-extremity orthotics, and we want to be able to share our successes with the entire orthotic community. We have waited for this day to ensure that the devices we have created are successful through fitting in an actual clinical situation on real patients. And now, we are comfortable to begin providing our services to allow other facilities to begin utilizing these custom orthoses for their patient population

Noel J. Chladek, CO, can be contacted at Bio-Mechanical Composites Inc., 1300 Keo Way, Des Moines, IA 50309; phone: 515.554.6132