More than a third of Ponseti-corrected clubfeet relapse and require additional treatment. Making a complete initial correction, ensuring optimal brace comfort, and encouraging parental buy-in to bracing over the long term reduces brace nonadherence, a major cause of recurrence.
By Barbara Boughton
Since the 1980s, treatment of idiopathic clubfoot with the Ponseti method has become increasingly popular among orthopedic specialists and surgeons due to the method’s superior long-term results. The Ponseti method is minimally invasive since it relies on serial casting, Achilles tenotomy, and bracing, and patients don’t suffer the postoperative and long-term consequences associated with comprehensive surgical clubfoot release.
According to recent studies, clubfoot surgeries among children younger than 6 months have declined by 6.7% per year.1 This shift is primarily due to increased use of the Ponseti method, which is associated with better functional and biomechanical outcomes than more invasive surgical protocols.2
Still, studies have reported clubfoot recurrence rates as high as 40% with the Ponseti method.3 Although research has shown the severity or type of clubfoot deformity can cause recurrence, many studies have highlighted that the strongest predictor of recurrence with the Ponseti method is nonadherence to bracing. In fact, nonadherence is associated with a five- to 183-times greater risk of relapse and need for surgical intervention.3,4
A number of studies have investigated the reasons for parental nonadherence to bracing. Studies have revealed that skin irritations, practical problems in applying the brace, and a child who fusses and cries with brace wear are significant barriers to use. Failure to understand the importance of bracing, forgetting or confusing instructions about brace use, and lack of continuity in medical care are also significant predictors of nonadherence. The treatment regimen is a significant—and sometimes overwhelming—challenge for parents, since it involves keeping the child in the brace for at least 23 hours at the start, with wear time gradually decreasing until the brace is worn only at night and during sleep.
Bracing also needs to be continued for three to five years, and studies have shown that by the time the child is aged 3 years, parents are often no longer able to convince them to sleep with the brace.3 Difficulties in incorporating the brace into the family’s social life, lack of a sufficient support system at home, and language and cultural barriers can also lead to nonadherence, according to recent research.3,5
“Using the brace does require careful parental compliance for the entire duration of the patient’s childhood, and that can feel overwhelming,” said Rachel Goldstein, MD, MPH, assistant professor of pediatric orthopedics at Children’s Hospital in Los Angeles. Goldstein has studied risk factors for recurrence—as well as nonadherence—in patients with idiopathic clubfoot who undergo the Ponseti method.4
Yet, whether parental nonadherence is due entirely to these challenges is open to question, she noted.
“The question that research has not answered is whether kids stop tolerating the brace and parents stop putting it on because the feet are recurring—or is it that parental nonadherence leads to the recurrence?” Goldstein said.
Several studies have noted that brace intolerance can contribute to nonadherence. To reduce brace intolerance, review studies and clinicians interviewed by LER: Pediatrics emphasize the importance of obtaining a complete correction from casting and tenotomy.3
“Casting and tenotomy has to completely correct both abduction and dorsiflexion, so that the feet fit comfortably in the brace,” said Peter Smith, MD, a pediatric orthopedist at Shriner’s Hospital for Children and professor of orthopedic surgery at Rush University Medical Center, both in Chicago. “Not completely correcting the deformity is a common mistake that can lead to poor compliance. Braces can only maintain the correction to prevent recurrence—they don’t actually correct the clubfoot deformity.”
By striving to attain 75° of abduction and 15° of dorsiflexion through casting and tenotomy, and providing careful education to parents, the Shriner’s Hospital for Children has attained what Smith estimates to be a 90% compliance rate.
Review articles have highlighted the difficulties parents face while trying to use braces over an extended time.3
“It is not that easy to put a brace on a child every day. At first, during infancy, brace wear is not that problematic, because the child is sleeping most of the time,” said Jose Morcuende, MD, PhD, professor in the department of orthopedic surgery and rehabilitation at the University of Iowa in Iowa City.
When the child begins walking and becomes more verbal, however, he becomes more aware of the discomfort and awkwardness of the brace, Morcuende said.
Parents can become less adherent when the child begins to walk because the foot appears to have regained normal function once the child becomes more active, said Lewis Zionts, MD, a clinical professor of orthopedics at the David Geffen School of Medicine at the University of California, Los Angeles.
Parents also cannot always distinguish between discomfort and pain when a child cries, so they may take the brace off if they assume it is painful. Frequent removal of the brace over time can increase the risk of relapse; the brace becomes more difficult to apply properly, because it no longer fits the child’s leg correctly. The child then experiences increased discomfort with brace wear and is more likely to become fussy or complain about wearing the brace—creating a vicious cycle that leads to recurrence, Zionts said.3
Research shows there is little difference between different types of braces in terms of adherence.6 However, addressing skin irritations or sores promptly by adjusting the fit of the brace, using a pressure saddle, or putting the foot in a cast if ulcers develop can improve adherence, experts say.3 Redness or skin irritation around the ankle affects about 30% to 40% of patients who undergo treatment with the Ponseti method, Morcuende estimated—often
because the braces are not tight enough and the foot is able to move up and down in them. Yet true sores or ulcers are uncommon, and most skin problems are unlikely after the first month if the parent is using the brace properly, he added.
“Serious skin problems [sores or ulcers] with bracing are rare, and are almost always associated with pulling the straps too tightly,” said John Herzenberg, MD, head of pediatric orthopedics at Sinai Hospital in Baltimore and clinical professor of orthopedics at the University of Maryland Medical School in Baltimore. “These problems can generally be addressed successfully by educating the parents about how to properly apply the shoes of the brace,” he added.
For compliance, experts say, it’s crucial for physicians to engage parents with educational strategies, including detailed instructions and continued education over time about brace wear, and continue to stress to them the importance of bracing.
“The parents need to understand the mechanism of the bracing, and they have to buy in to the treatment,” Morcuende said. “The doctor has to continually reinforce the concept that bracing is crucial to the child’s recovery, and to tell the parent that, without bracing, the child may need to go back to casting or surgery.”
Yet, it is not only parents who have an important role to play in adhering to the bracing regimen. Practitioners have to be dedicated educators, and knowledgeable about the time commitment needed to prevent recurrence with bracing.
“The doctor has to be one-hundred percent convinced that the brace should be worn over several years,” Morcuende said.
Three to five years of bracing is generally recommended, but Morcuende’s research indicates that many orthopedic surgeons believe it can be discontinued after two to three years. A recent survey by Morcuende and colleagues of 321 members of the Pediatric Orthopaedic Society of North America (POSNA) indicated that 23% recommended bracing for just two years and 32.6% recommended bracing for three years. The researchers will present the survey results at the April 2016 POSNA meeting in Indianapolis, IN.7 A similar survey of 323 POSNA members published in 2012 by Morcuende et al revealed that, among patients with clubfoot who underwent the Ponseti method, braces were worn for an average of 33 months.8
Morcuende told LER: Pediatrics that his group’s recent research, based on a national database of pediatric hospitalizations, indicates the rate of surgical clubfoot correction after children are aged 1 year has risen slightly from 1997 to 2012. (This research has not yet been published or presented.) If Ponseti treatment is initiated by age 26 weeks, as recommended,3,9 casting and the first three months of 23-hour bracing should be completed well before the child’s first birthday.
“Doctors are doing a good job of correcting the deformity with the Ponseti method before one year of age, but after that, they are performing surgeries that are unnecessary,” Morcuende said. “The increased rates of surgery after one year of age represent the failure of bracing adherence, and point outs that doctors need to understand the value of bracing for a sufficient amount of time.”
Experts recommend that physicians explain the importance of bracing at the initial appointment—even before casting. At each clinic visit, the doctor should emphasize the crucial role of bracing in achieving a successful outcome, and why it helps avoid recurrence and corrective surgery. Most clinicians interviewed by LER Pediatrics said they provide parents with verbal instructions about bracing before the parents receive the brace. The parents also practice applying a sample brace or the patient’s actual brace on a large teddy bear or doll under the supervision of a nurse or medical assistant.
“Using a doll is less distracting during a twenty-minute practice session [than practicing on an actual child], because a doll will not fuss or cry,” Morcuende said.
When the brace is ready, the parents will be asked to apply and take the brace off the child in the clinic and under supervision to ensure they are comfortable with it and are using correct technique, Smith said.
A review by Zionts and colleagues indicated that using written instructions tailored to the parents’ education level as well as explanatory videos parents can take home may help improve adherence.3 Most experts recommend that printed patient educational materials be written at or below a sixth-grade reading level (see “Health literacy: The challenge of making clinical information accessible to patients,” LER, September 2015, page 18). Studies have shown anxiety impairs memory, and lack of adherence has been linked to misunderstood or forgotten instructions.3,10 So, Zionts noted, physicians should urge parents to ask questions during instructional sessions.
In addition, physicians should encourage parents to call or visit the clinic if they encounter any difficulties, especially any skin irritation or brace-related pain. Zionts also advises that a clinic nurse call the parents the day after they receive the brace to make sure they’re not having problems. Most clinicians interviewed for this article also follow the patient with weekly clinic visits until they are sure the child is tolerating the brace.
Although patients will be seen less frequently after the initial period of adjustment—with visits typically every six months—it’s vital to continue assessing adherence by querying parents about how long the brace is being worn. Doctors should also strive to continue to educate parents and discuss any difficulties, Zionts said.
“It’s important to address and try to resolve any problems that have arisen, especially after the child begins to walk. After the child starts to walk, and the parents see that the foot is corrected, brace use tends to fall off, in my clinical experience,” he said.
Zionts and other experts also said physicians should avoid being judgmental when discussing nonadherence with parents who are failing to use the brace.
“There are barriers to compliance that are outside the control of the parents, including financial problems and transportation difficulties that affect childcare or missed appointments,” Herzenberg said. “It’s worthwhile to recognize and be understanding about the difficulties the parents are facing, and work to lower any barriers. It’s not helpful to be pejorative and critical—that does not encourage adherence.”
Parent support groups, including web-based groups such as “nosurgery4clubfoot” on yahoo.com, allow parents to gain encouragement from and commiserate with their peers. Rachel Goldstein sometimes puts parents who are new to bracing in touch with others who are further along in the treatment process. That way, parents with less bracing experience have more realistic expectations about the treatment regimen, and can gain insight into solving practical problems, she said.
For instance, one set of parents in Goldstein’s practice found their child would regularly bang the brace against the wall and crib to express frustration with its awkwardness. Other parents who had experienced the same problem were able to advise them to cover the brace with a towel to minimize damage to the brace or crib and resist the temptation to remove the brace.
“This is the kind of problem that I, as a physician, couldn’t anticipate, and I probably would not hear about it in a clinic visit once a week,” Goldstein said. “By connecting with other parents, who have practical solutions to the problems they encounter, it’s easier for parents to comply.”
Barbara Boughton is a freelance writer based in the San Francisco Bay Area.
- Zionts, LE, Zhao G, Hitchcock K, et al. Has the rate of extensive surgery to treat idiopathic clubfoot declined in the United States? J Bone Joint Surg Am 2010;92(4):882-889.
- Smith PA, Juo KN, Graf AN, et al. Long-term results of comprehensive clubfoot release versus the Ponseti method: Which is better? Clin Orthop Relat Res 2014;472(4):1281-1290.
- Zionts LE, Dietz FR. Bracing following correction of idiopathic clubfoot using the Ponseti method. J Am Acad Orthop Surg 2010;18(8):486-493.
- Goldstein RY, Seehausen DA, Chu A, et al. Predicting the need for surgical intervention in patients with idiopathic clubfoot. J Pediatr Orthop 2015;35(4):395-402.
- Goksan SB, Bilgili F, Eren I, et al. Factors affecting adherence with foot abduction orthosis following Ponseti method. Acta Orthop Traumatol Turc 2015;49(6):620-626.
- Hemo Y, Segev E, Yavor A, et al. The influence of brace type on the success rate of the Ponseti treatment protocol for idiopathic clubfoot. J Child Orthop 2011;5(2):115-119.
- Hosseinzadeh P, Keibzak G, Dolan L, et al. Management of clubfoot relapses with the Ponseti method: Results of a survey of POSNA members. Accepted for presentation at the annual meeting of the Pediatric Orthopedic Society of North America, Indianapolis, April 2016.
- Zionts LE, Sangiorgio SN, Ebramzadeh E, Morcuende JA. The current management of clubfoot revisited: Results of a survey of the POSNA membership. J Pediatr Orthop 2012;32(5):515-520.
- Zionts LE, Frost N, Kim R, et al. Treatment of idiopathic clubfoot: Experience with the Mitchell-Ponseti brace. J Pediatr Orthop 2012;32(7):706-713.
- Martin LR, Williams SL Haskard KB, et al. The challenge of patient adherence. Ther Clin Risk Manag 2005;1(3):189-199.