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Zofran and Birth Defects - Club Foot

Club Foot:

Clubfoot, also called congenital talipes equinovarus (CTEV), is a congenital deformity involving one foot or both. The affected foot appears to have been rotated internally at the ankle. Without treatment, people with club feet often appear to walk on their ankles or on the sides of their feet. However with treatment, the vast majority of patients recover completely during early childhood and are able to walk and participate in athletics as well as patients born without CTEV.

It is a relatively common birth defect, occurring in about one in every 1,000 live births. Approximately half of people with clubfoot have it affect both feet, which is called bilateral club foot. In most cases it is an isolated disorder of the limbs. It occurs in males twice as frequently as in females.

Causes and Risk Factors
The cause for clubfoot has generally been thought to be multi-factorial and including genetics, growth rate affected by amniotic fluid, and other factors. Recent studies suggest that use of the medication Zofran® (ondansetron) may increase the risk of this condition.

Hippocrates, the father of medicine, was the first to make a hypothesis about the cause around 400 B.C. and still to this day there are many other hypotheses for clubfoot pathogenesis. Most of the studies have concluded that clubfoot may be caused by environmental factors, exposure to toxins, physical limitations to proper growth, genetics, or a combination of both.
Modern advances in genetic mapping techniques and the development of mouse models of the disease have improved understanding of the control of developmental processes. Genetic epidemiology studies have led to a more recent hypothesis that is said to be the closest in finding the etiology of clubfoot.


Clubfoot is usually diagnosed immediately after birth simply by looking at the foot. It is then up to the doctor whether or not to x-ray the foot or feet to examine how the internal structures are positioned. In some cases, it may be possible to detect the disease prior to birth during the ultrasound. It may be more prominent if both feet are affected. The ability to possibly identify clubfoot before live birth can prove beneficial to the child as different treatments can be explored.

Once a child has been diagnosed with clubfoot, there are many different treatment approaches. Treatment should be given immediately after diagnosis to take full advantage of the flexibility in the baby’s bones and joints. This allows for improved manipulation to try to achieve a normal foot. The Ponseti method appears to result in better outcomes than the Kite method and similar outcomes to a traditional technique.

This involved manipulation by people specialized in the technique with serial casting and then providing braces to hold the feet in a plantigrade position. After serial casting, a foot abduction brace such as a Denis Browne bar with straight lace boots, ankle foot orthoses and/or custom foot orthoses (CFO) may be used. Manipulation is followed by serial casting, most often by the Ponseti method. Foot manipulations usually begin within two weeks of birth.

Extensive surgery of the soft tissue or bone is not usually necessary to treat clubfoot; however, there are two minimal surgeries that may be required:

• Tenotomy - clipping of the Achilles tendon – is needed in about 80% of cases.
• Anterior tibial tendon transfer, in which the tendon is moved from the first toe to the third in order to release the inward traction on the foot, is needed in about 20% of cases.

In most cases extensive surgery is not needed to treat clubfoot. Extensive surgery may lead to scar tissue developing inside the child's foot. The scarring may result in functional, growth and aesthetic problems in the foot because the scarred tissue will interfere with the normal development of the appendage. A child who has extensive surgery may require on average two additional surgeries to correct the issues presented above.

In stretching and casting therapy the doctor changes the cast several times over a few weeks, gradually stretching tendons until the foot is in the correct position of external rotation. The heel cord is released (percutaneous tenotomy) and another cast is put on, which is removed after three weeks. To avoid relapse a corrective brace is worn for a gradually reducing time until it is only at night up to four years of age.

Ponseti method

This treatment requires stretching. The foot is repositioned to the normal position then a cast (the "Ponseti cast") is placed on top of it. The baby’s foot is then continually repositioned and placed back into a cast once a week for several months. Towards the end of the process after being in a cast, the doctor will then surgically lengthen the heel cord (aka Achilles tendon). After the foot has been realigned, maintenance involves routine stretching. The child also has to wear special shoes or braces full-time for three months, then just nightly for three years. This method can be compared to wearing braces on your teeth. Parents have to follow the doctor’s orders for when to wear and not wear the brace to keep the foot corrected. Failure will occur if the brace is not worn and the foot will return to its odd shape.

Treatment for clubfoot should begin almost immediately to have the best chance for a successful outcome without the need for surgery. Over the past 10 to 15 years, more and more success has been achieved in correcting clubfeet without the need for surgery. The clubfoot treatment method that is becoming the standard in the U.S. and worldwide is known as the Ponseti method. Foot manipulations differ subtly from the Kite casting method which prevailed during the late 20th century. Although described by Dr. Ignacio Ponseti in the 1950s, it did not reach a wider audience until it was re-popularized around 2000 by Dr. John Herzenberg.

Parents of children with clubfeet using the Internet also helped the Ponseti gain wider attention. The Ponseti method, if correctly done, is successful in >95% of cases in correcting clubfeet using non- or minimal-surgical techniques. Typical clubfoot cases usually require five casts over four weeks. Atypical clubfeet and complex clubfeet may require a larger number of casts. Approximately 80% of infants require an Achilles tenotomy (microscopic incision in the tendon requiring only local anesthetic and no stitches) performed in a clinic toward the end of the serial casting.


After correction has been achieved, maintenance of correction may require the full-time (23 hours per day) use of a splint—also known as a foot abduction brace (FAB)—on both feet, regardless of whether the TEV is on one side or both, for several weeks after treatment. Part-time use of a brace (generally at night, usually 12 hours per day) is frequently prescribed for up to four years. Without the parents' participation, the clubfoot will almost certainly recur, because the muscles around the foot can pull it back into the abnormal position. Approximately 20% of infants successfully treated with the Ponseti casting method may require a surgical tendon transfer after two years of age. While this requires a general anesthetic, it is a relatively minor surgery that corrects a persistent muscle imbalance while avoiding disturbance to the joints of the foot.

The long-term outlook for children who experienced the Ponseti method treatment is comparable to that of non-affected children.
Botox is also being used as an alternative to surgery. Botox is the trade name for Botulinum Toxin type A, a chemical that acts on the nerves that control the muscle. It causes some paralysis (weakening) of the muscle by preventing muscle contractions (tightening). As part of the treatment for clubfoot, Botox is injected into the child’s calf muscle. In about one week, the Botox weakens the Achilles tendon. This allows the foot to be turned into a normal position over a period of 4–6 weeks, without surgery.

The weakness from a Botox injection usually lasts from 3–6 months. (Unlike surgery, it has no lasting effect). Most club feet can be corrected with just one Botox injection. It is possible to do another if it is needed. There is no scar or lasting damage.

In severe cases, surgery may be the only option to correct the foot after trying all other non-invasive methods for treatment. Surgery does not ensure full recovery, but most babies who underwent the surgery have maintained their normal feet. A surgeon will go in and lengthen the muscles and tendons to ease the foot into position. After surgery when the cast is removed, a brace is to be worn to prevent the foot from returning to the old position.

On occasion, stretching, casting and bracing are not enough to correct a child's clubfoot. Surgery may be needed to adjust the tendons, ligaments and joints in the foot/ankle. Usually done at 9 to 12 months of age; surgery usually corrects all clubfoot deformities at the same time. After surgery, a cast holds the clubfoot still while it heals. It is still possible for the muscles in the child's foot to try to return to the clubfoot position, and special shoes or braces will likely be used for up to a year or more after surgery. Surgery will likely result in a stiffer foot than nonsurgical treatment, particularly over time.

Without any treatment, a child's clubfoot will result in severe functional disability, however with treatment, the child should have a nearly normal foot. He or she can run and play without pain and wear normal shoes. The corrected clubfoot will still not be perfect, however; a clubfoot usually stays 1 to 1½ sizes smaller and somewhat less mobile than a normal foot. The calf muscles in a leg with a clubfoot will also stay smaller.

Clubfoot Into Adulthood
Long-term studies of adults with post-club feet, especially those with substantial numbers of surgeries, may not fare as well in the long term. A percentage of adults may require additional surgeries as they age, though there is some dispute as to the effectiveness of such surgeries, in light of the prevalence of scar tissue present from earlier surgeries.

In some cases the leg stops developing earlier than the healthy leg and a substantial length difference may occur. In some cases a leg lengthening will be necessary, most commonly by use of the Ilizarov method.


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