Increasing compliance with 3D-printed AFOs for relapsed club foot

By
Christabelle Asoluka
September 19, 2022

Four-year-old Nambi was born with congenital talipes equinovarus (CTE, also known as club foot) and tendo achilles tightness bilaterally. As any other four-year-old, Nambi is highly active and enjoys a wide range of activities. She has been prescribed ankle foot orthoses (AFO) to help maintain her correction and also has physical therapy sessions.

However, she was starting to outgrow her Cunningham brace (a type of AFO) and she was facing a relapse. So Nambi’s mom spoke with medical professionals about a non-invasive way to further improve her mobility following Nambi’s fourth tenotomy. All while allowing her to maintain her active lifestyle.  

The solution? 3D-printed AFOs.

Why turn to pediatric AFOs for the treatment for club foot?
Following the successful correction of CTE using the Ponseti method, it is possible for growing children to relapse. Relapses are recurrent deformities in previously well-corrected feet.

Major reasons for relapsed/residual clubfoot include incomplete application of the Ponseti principles, inability to adhere to the foot abduction brace protocol, failure to recommend a complete course of bracing and inadequate follow-up. Surgical interventions like tenotomy in the more severe case are common practice, but appropriate orthoses must be chosen to maintain the resulting degree of correction.

Parents and carers of children above the age of 1 no longer want their children to use the commonly prescribed Dennis brown shoes as it hinders them from walking and other activities akin to growing children.

Custom ankle-foot orthosis (AFO) may be fabricated to meet the requirements of a clinician prescribing non-invasive treatment for post-surgical clubfoot care.

To opt for a custom-made AFO for a child over one year is quite tricky because the demands for comfort are higher, and the possibility of low compliance is high as well. Bulky unbreathable devices that are traditionally fabricated do not offer the comfort nor the compliance necessary to maintain this correction.

This is where we turn to 3D-printed AFOs.

3D printed AFOs are capable of being designed to accommodate every aspect of design and manufacture, making it easier for the clinician, parent, and, ultimately, the child.
AFOs have a unilateral design that promotes early walking and improved gait in young children. Its lightweight property enhances comfort since the child is comfortable wearing them for long hours. Perforations along the orthoses allows breathability to avoid any skin irritation as children's skin is sensitive to prolonged use of plastic material. Addition of fun colors and designs that get the children excited about their brace that they look forward to wearing it, which eventually improves compliance.

The process

Once Nambi had been evaluated for a 3D-printed brace, the next step was to scan her foot.

Spentys is one of the few platforms that allow you to scan with any available scanner and import it into the iPad.Once the accurate scan of her feet was obtained, it was imported into the Spentys workflow.

Once in the Spentys app, the clinician was able to choose the actual product, which in Nambi's case was our B8 (Articulated AFO), and followed the step-by-step instructions.

AFO workflow for B8


Within 20 minutes of the entire consultation the scan and desired timelines were submitted to Spentys. Then Nambi got involved in this process as well and could choose the color of her brace as well as the design she liked.
Nambi's mother said that the level of precision that went into the customization was one of the things she loved the most about the process.

The outcome

Upon receiving the AFO, Nambi's mother was instantly impressed by how lightweight the devices were. The Aveolis on every Spentys brace accounts for about 20% of the reduction in the weight of the device whilst ensuring that it is completely breathable. These AFOs do not need any extra layer of padding as they are comfortable and interact nicely with the skin. Nambi was able to wear her AFOs without assistance and was comfortable enough to have them worn with her shoes.

I think a month into wearing them, I noticed that her gait was well improved, especially when she is wearing them, she can run in them, she can walk in them, she can stand because one of the things that she did she does without them is that she tends to stand on her toes. But when she's wearing them, her feet up plantigrade.
Nambi's Mother
Nambi: Increasing compliance with 3D-printed AFOs

For children past 12 months, the available options to maintain the correction obtained from the Ponseti method are limited. From 15 months to 2 years: infant's feet will grow half a size every two to three months. This then implies that the financial cost and time required to have traditional fabricated AFOs TFAFOs will increase and become burdensome on both the child and parents. More so, these TFAFOs tend not to fit the child's anatomy accurately.

I found that the traditionally made orthoses were very narrow at the toes for Nambi, which made her toes really crammed, which she complained about every time.

In the research by Haft et al., the non-compliance rate was 49%, and patients who did not adhere to the bracing protocol were five times more likely to have a relapse in comparison with children who wore the brace regularly. Dobbs et al. found that the non-compliance rate was 41% and children who discontinued wearing the brace were 183 times more likely to have a recurrence of clubfeet.

From the success story of Nambi, we saw that her general clinical improvement resulted from the fact that she complied with wearing the AFO for longer hours as she could use them to play and go about her daily activities without restraint.

Typically, I would say she wears the AFOs about 16 to 18 hours a day. So when she gets up in the morning, she puts them on. And then, she spends the entire day with them until around bath time, which is around 6 pm. And then we do our stretch and our physical therapy and other things. And so that the compliance is much higher. And it's I think it's in large part because of the way that they're designed.
-Nambi’s mother

3D-printed AFOs have a number of advantages, as stated in this article, that ultimately point towards improved patient compliance and satisfaction. The manufacturing process is seamless and repeatable, which is perfectly suited for a growing child prone to relapse. The entire consultation period can last for 10-15 minutes, and the patient receives the brace in their home.

To learn more about Spentys products, click here.
Or to get in touch to learn about bringing pediatrics AFOs to your practice, get in touch.

References

Zhao D, Liu J, Zhao L, Wu Z. Relapse of clubfoot after treatment with the Ponseti method and the function of the foot abduction orthosis. Clin Orthop Surg. 2014 Sep;6(3):245-52. doi: 10.4055/cios.2014.6.3.245. Epub 2014 Aug 5. PMID: 25177447; PMCID: PMC4143509.

Haft GF, Walker CG, Crawford HA. Early clubfoot recurrence after use of the Ponseti method in a New Zealand population. J Bone Joint Surg Am. 2007;89(3):487–493.

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