PRAFO: The New Revolution in Combating Pressure Sores in Patients

by Jessica Mancini

One day, in 1995, while getting out of the tub, Mrs. Theresa Davies slipped on the tile floor of her bathroom. The 78 year-old woman fell to the ground breaking her hip and fracturing her leg in two places. When the paramedics came to the scene, they evaluated the need for immediate surgery. Mrs. Davies is taken to the hospital and placed under the care of the medical team which includes her surgeon and an orthopedic consult. Her injuries require surgery to replace her hip and the casting and eventual bracing of her leg. Mrs. Davies will have to spend a inordinately long period of time in a hospital bed and possibly need to be placed in a nursing home because of the restriction of movement from the healing process of the replaced hip.

The diagnosis of Mrs. Davies presents some possible complications in her treatment. One of the foremost secondary problems is the occurrence of ulcers on the Achilles heel portion of the foot. These ulcers are common in patients who spend a long time in a recumbant position. These ulcers are also referred to as pressure sores. They occur when fluids and blood that are normally distributed through the body build up due to lack of movement on the patient's part. The location on the patient where these sores occur is the point of contact of the foot (the Achilles heel region) and the bed. These ulcers are particularly troublesome because often times they lead to expensive medical treatment or even foot amputation.

The cost of treating a pressure sore can run as high as $4,255.00. Typical monthly costs for nursing personnel, both licensed and non-licensed, is $3,069.00 and transport services and supplies amounting to $1,186.00. The transport and supplies involve things such as pressure relieving devices, pharmaceutical supplies and laboratory fees. The question arises whether anything that can be done about the current problem facing Mrs. Davies and her medical team that will both be cost effective and beneficial to the patient.

The answer is yes. A new device in orthopedic bracing has been invented that will take care of the complications and pain of pressure sores. In late 1990, Anatomical Concept Inc. based in Youngstown, Ohio developed a device named the PRAFO in order to alleviate these problems. PRAFO is an abbreviation for Pressure Relief Ankle Orthosis (brace). It provides a ninety degree alignment of the ankle foot complex and alleviates pressure on the Achilles heel region, which supports more than normal body weight to alleviate potential heel ulcerations. The PRAFO also works well for treating heel ulcerations because it controls internal and external rotation of the hip. By providing control of the rotation of the hip, the foot is not able to rotate from one side to the other which allows the body to absorb some of the built up fluid. It is designed to be used as both an ambulatory and recumbant device for patients.

According to inventors and orthotists William DeToro and James Mancini the need for the PRAFO arose out of treatment problems and complications arising out of a case like Mrs. Davies. "We were seeing a great number of patients who developed heel ulcers due to lengthy bedfast periods. The current methods of treatment were not effective in combating or treating these ulcers once they occurred." says Mr. Mancini. The current methods for treatment were AFOs, which stands for Ankle Foot Orthosis. "The current treatment consists of primarily AFOs that are custom-fit to the patient and generally casted over the orthosis. These devices do not provide the necessary ambulatory requirements involved in the rehabilitation process of these patients. The AFO's aren't effective in preventing or treating the specific problem of heel ulcers either." continues DeToro. The two orthotists combined their efforts with another expert, Rick Riffle, to create the PRAFO .

The PRAFO differs from the AFO in design because it allows the patient to be ambulatory as well as supine. It is also more versatile in the types of ailments and injuries to which it can be applied. The PRAFO can be used in the treatment of Multiple Sclerosis, Cerebral Palsy, head trauma cases where rehabilitation requires physical therapy, multiple trauma cases, cardiac procedures which involve lengthy bedfast recoveries, orthotic procedures such as hip replacements, and bedfast patients in general.

The PRAFO itself is simply constructed . It comes in four different forms which are marketed all over the United States and Europe. They are the PRAFO, PRAFO KAFO Attachment, the PRAFO EV and the Custom Made PRAFO. The generic classification for the PRAFO system is ankle foot orthosis; single, metal, posterior upright and thermoplastic calf and foot segments. Translated into laymen's terms the four braces in the PRAFO system are all below knee braces that extend from the mid-calf to beyond the distal (tip) end of the toes. The braces (orthoses) are made of a polypropylene calf form segment that has a channel engraved in it into which an anatomically formed upright structure of anodized aluminum or stainless steel fits. The upright is attached at both ends to the calf segments with brass screws and retainers. Attached to the middle of the calf segment is the rotation control bar. An additional segment of polypropylene is extended from the foot plate just beyond the distal segment of the toes. A rubber walking base is attached to the bottom of the foot plate and a bootie made of Kodel or wool slips over the bare frame in order to pad the patient's leg. The PRAFO can be used without the walking base and liner.

The dual functionality of the PRAFO allows for the patient, while confined to the hospital, to be fitted for the brace to alleviate the ulcers using only the skeletal frame of the brace. When the patient begins rehabilitation, the liner and walking base can be added to allow ambulatory movement. The remarkable aspect of the PRAFO is that because of the walking base and the liner no special footwear is needed. The PRAFO allows the patient to get up and walk around because the orthosis offers support and rotation control as well as primary foot gear which permits ambulatory use. The braces in the PRAFO system are adjustable in length and can be adjusted to increase or decrease the ankle-foot relationship to the calf, and relationship to the shin. This means that for the first time in a device, you can have either an adjustable posterior or anterior stop.

The PRAFO is only available through a certified orthotist. A doctor's referral to a certified orthotist for evaluation in the primary stage of treatment is needed to obtain the orthosis. The cost ranges from $160.00 to $290.00 depending on the model of PRAFO and the necessary accessories the physician desires for the patient. Though this does seem like quite an expense for a simple orthosis, but Medicare and most insurance companies do cover the cost of the bracing as necessary orthotic procedure.

The significance of a device like the PRAFO is invaluable to patients like Mrs. Davies. The orthosis is the solution to alleviating the problematic pressure sore which leads to amputation if not treated properly. Mrs. Davies is spared the pain and trauma of losing a limb and provided a relatively inexpensive brace that can be used during bed confinement and physical therapy. Being an ambulatory device, the PRAFO will allow Mrs. Davies mobility when she returns home and continues effective treatment for her condition.