Ingrown toenail is a very common condition most of us treat on a daily basis. Yet, after more than 27 years in practice, I have not really changed the way I approach them. Recently, I decided to look at possible alternative options for treatment that may be less invasive and/or traumatic to the toenail, and the patient.
Often, we may or may not properly address the underlying biomechanical condition that contributes to the formation of ingrown toenail. There may also be structural conditions to consider, such as subungual exostosis or hallux valgus deformity. Shoes may also play a role in causing pressure on the toes. Leaving these possible etiologies aside for the time being, we often reach for the “easiest,” most common tool among our options: avulsion and/or chemical or mechanical ablation/matrixectomy.
Over the past two to three months, I have seen more and more patients with ingrown or pincer nails who refuse any type of injection. This may be due to a previous bad experience from another provider or even another podiatrist. In these cases, I often cut out the edges very gently in hopes of building trust so in one to two weeks, I can have these patients return for a matrixectomy if warranted.
I then recalled an article I read about five years ago that discussed a surgical device for ingrown toenails that one implants and then turns to reduce the curvature of the toenail. While I could not track down the original article, when I did a Google search, numerous similar devices came up that are apparently available on Amazon or via other vendors for home do-it-yourself treatments.
One such device is called Makizume Robo (Fine Hearts) and has hooks on the sides that attach to the nail plate. One then turns a center clamp/screw-like device, which pulls the medial and lateral borders of the nail up. One then soaks the toe in warm water for 20 minutes and turns the device some more to get additional lifting of the nail. I do not know if it really works or who would want to crank this weekly, but it is available.
I also came upon a little jar of spring-like hooks with a similar process. This seems similar to the use of super elastic wire that Moriue and colleagues reported on in 2008.1 For the hooks, there does not seem to be instructions to soak the foot or an indication of when to remove the device. It seems that one leaves the device on as the toenail grows out.
The closest approximation I found to the original implant I read about years ago is the K-D device (S & C Biotech), which involves surgically cutting the medial and lateral borders of the nail to implant the device, and turning it weekly to reduce the curvature on the edges. If patients do not want an injection to facilitate removal of the nail borders, would they want me to inject them to implant this device?
Other authors have discussed techniques for taping the nail borders down to reduce pressure to the skin from the nail edge.2,3 These techniques include the use of a flat brace or sleeve, and a gutter treatment made of vinyl or metal with a slit pushed along the nail edge to pull the nail away from the skin border. This may work for mildly curved nails but a pincer nail does not lend itself to having a tube slipped down the edge.
Then I came across a new product called Onyfix® (Onyfix), a Class I medical device, which is marketed as a painless option for the correction of involuted toenails.4 The process with this product reportedly involves the placement of an acrylic-like material on the proximal nail fold. This material subsequently hardens and as the nail grows out, it supports a reduced curvature of the nail. There are six to seven steps that one has to follow but the process appears relatively easy once one does two to three applications of the material.
With the full realization that the articles noted by the Onyfix manufacturer are not randomized controlled studies, and without fully knowing the study design, I decided to see for myself how Onyfix would work. I obtained the product from a U.S. distributor and started to offer this as a possible alternative to my patients. While Onyfix reportedly has a 510(k) clearance from the Food and Drug Administration (FDA), it is not a covered procedure from an insurance plan perspective. I offer it as a non-covered procedure in my practice. I also advise patients that Onyfix is likely considered experimental as there has not been any studies done or published in the U.S. as of yet.
I have only used Onyfix for one month in my practice as of the publication of this blog but the immediate acceptance of the product by patients has been overwhelming with only about 10 percent of my patients wanting the phenol procedure. Almost all of my pediatric patients would prefer Onyfix. This is with the full understanding that re-application will be necessary in two to three months and that it may take nine to 12 months to see the full results. They are just happy that the treatment does not hurt and that they do not have to have an injection. Anecdotally, I have also noted immediate pain relief at the nail borders after the application of Onyfix.
Again, while my experience with Onyfix is anecdotal and limited to one month, I thought I would share it with you in case you see a potential role for it in your practice. In regard to disclosures, I am not doing a study for the device company or the distributor. I am not a consultant for the device’s manufacturer and have no financial relationship with the company.
Since the COVID-19 pandemic hit in the United States, I have been looking at newer treatments that are not surgically driven and which may offer my patients gentler, less invasive approaches. For my patients with diabetes who may have vascular issues or other challenges with wound healing, I have found anecdotally that Onyfix is still a safe procedure for preventing ingrown nails and infection. In turn, we may be able to avoid potential complications for others at high risk, such as those with immune compromise.
- Moriue T, Yoneda K, Moriue J, et al. A simple therapeutic strategy with super elastic wire for ingrown toenails. Dermatol Surg. 2008;34(12):1729-1732.
- Watabe A, Yamasaki K, Hashimoto A, Aiba S. Retrospective evaluation of conservative treatment for 140 ingrown toenails with a novel taping procedure. Acta Derm Venereol. 2015;95(7):822-825.
- Tsunoda M, Tsunoda K. Patient-controlled taping for the treatment of ingrown toenails. Ann Fam Med. 2014;12(6):553-555.
- Hanisch E. Physiological and painless treatment of ingrown and curled toenails. Kosm Med. 2018;3(18):118-123.
5. Haneke E. Controversies in the treatment of ingrown nails. Dermatology Research and Practice. 2012. Available at: http://downloads.hindawi.com/journals/drp/2012/783924.pdf . Accessed August 20, 2020.