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The Top Ten Innovations In Podiatry

Can a new advance enhance external fixation? Could a native collagen product have an impact in counteracting biofilm recurrence? Can emerging topicals provide epidermal barrier repair in patients prone to dry, irritated skin? Could an intriguing surgical system facilitate more consistent, reproducible first ray correction with Lapidus bunionectomy procedures? With these questions in mind, this author talked to leading experts in the field to get their thoughts on the latest innovations in podiatry.

This year’s innovations include a new wound matrix, external fixation for the Charcot foot, an intriguing acoustic wave technology for plantar fasciitis, an emerging approach for bunion repair and therapies for the diabetic foot and diabetic skin.

Salvation™ External Fixation System (Wright Medical). An emerging fixation product may provide a comprehensive surgical solution for the Charcot foot.

Wright Medical says the Salvation™ External Fixation System can address fractures, non-unions and complex foot and ankle deformities such as Charcot neuroarthropathy. H. John Visser, DPM, notes the

Salvation system includes bolts (non-cannulated screws) and beams (cannulated screws) as well as a 3Di Plating system. Wright Medical notes that the 3Di locking technology permits surgeons to place screws up to 15 degrees off-axis.

Dr. Visser also notes the Salvation’s ex fix system includes screws with an osteoporotic thread profile for patients with poor bone quality. He also cites the system’s anatomically designed medial column plate styles for patients with abnormal contour and bone loss.

The system utilizes tensioned thin wires, half-pins and rings, and also facilitates proper frame positioning and more efficient frame application, according to the company. Wright Medical adds that the Salvation system’s slotted ring design lets surgeons attach frame components quickly and easily as surgeons do not need to assemble small, threaded components. Salvation also has a Wire Guide, which the company says ensures precise wire placement on the ring, decreasing the need for additional connection components and extra surgical steps.

Dr. Visser, the Director of the Foot and Ankle Surgery Residency at SSM Health DePaul Hospital in St. Louis, has used the system for two years.

“(The Salvation system) offers one-stop shopping for Charcot,” notes Dr. Visser, who acknowledges the product’s beams/bolts for use in midfoot and Lisfranc repair.

He also cites the product’s locking plates to address bone loss and medial/lateral column stability.

Lapiplasty (Treace Medical Concepts). Surgeons can enhance their Lapidus bunionectomy results with a new surgical system.

The Lapiplasty can facilitate predictable and reproducible triplanar correction of the first ray in case after case, notes Jason Miller, DPM. As he notes, realigning the sesamoids in many patients is crucial to maintaining correction of the hallux abductovalgus deformity.

“It cuts precious OR time down significantly and typically allows for less shortening of the first ray as there is no guesswork in how much bone to remove,” maintains Dr. Miller, the Podiatry Residency Director at Phoenixville Hospital in Phoenixville, Pa.

Dr. Miller has used the system for two years “and will never go back to doing a traditional Lapidus again.”

The manufacturer Treace Medical Concepts says the Lapiplasty can provide control and reproducibility for the first tarsometatarsal joint fusion as it accurately positions the metatarsal in anatomic alignment, including frontal plane rotation. It adds that the Lapiplasty Positioner can close the intermetatarsal angle and derotate the metatarsal, providing anatomic alignment of the metatarsal and sesamoids.

When surgeons perform the procedure correctly, Dr. Miller says he has never seen a patient have excessive shortening or sagittal plane deformity after the correction.

The Lapiplasty is the only system that provides the surgeon with cutting blocks and a jig “to make the correction perfect,” according to Dr. Miller, an Adjunct Associate Professor in the Department of Surgery at the Temple University School of Podiatric Medicine. The system allows 5-, 7.5- and 10-degree corrections, which he notes will accommodate any patient’s deformity. Since the system is prepackaged sterile, this makes it easy for surgery centers or ORs to manage as there is no processing of the implants, according to Dr. Miller, who is a consultant for Treace Medical Concepts.

In addition, the company says its low-profile Biplanar™ Plating with the anatomic Plantar Python® Plate facilitates multiplanar stability and plantar plating via standard-sized locking screws to accommodate anatomic variations without the need for intra-operative measuring. Dr. Miller notes Lapiplasty comes with two plating options but only one set of screws for a “one size fits all” locking screw approach. As studies have demonstrated that locking screws do not perform statistically better with bicortical purchase, he says the company “ran with that concept” to simplify the sets.

Pertinent Insights On An Innovative Ankle Implant

Cadence Total Ankle System (Integra LifeSciences). An emerging ankle implant may be able to address the pain of ankle arthritis while preserving patient anatomy.

Describing the Cadence Total Ankle System as “the evolution of the ankle implant,” Arush Angirasa, DPM, says the fourth-generation implant is intuitive and can provide reproducible results. He has used Cadence for a year and notes the implant system takes into account anatomic variability, provides varus/valgus solutions and addresses anterior and posterior bias in order to ensure proper tibiotalar axis alignment.  

“In my opinion, anecdotally, implantation time is markedly decreased with Cadence and the system design is very user-friendly,” says Dr. Angirasa, a Fellow of the American College of Foot and Ankle Surgeons, and a partner at Southwest Orthopedic Group in Austin.  

The manufacturer Integra LifeSciences says use of the Cadence implant can treat systemic, primary or secondary ankle arthritis, leading to less pain, better alignment, and more movement at the replaced joint. The company says the implant includes a tibial tray, a talar dome and a polyethelene insert of various sizes and biases, and when surgeons implant all three components, the insert acts as a bearing along the talar dome, enabling flexion and extension movement at the replaced joint. Integra adds that the Cadence implant reduces the risk of injury to the malleoli and is designed to prevent dissymmetry and malalignment of the prosthesis.

Dr. Angirasa cites several advantages to the Cadence implant, namely the integration of the alignment guides and cutting guides, which he says eliminates the need for instrumentation swapping and also saves tourniquet and anesthesia time. Dr. Angirasa notes the alignment guide and jig are intuitive, and that surgeons can place and utilize the guide and jig without the need for fluoroscopy to ensure proper symmetry of the ankle joint.

Dr. Angirasa adds that the Cadence, with more than 670 combinations, offers the most comprehensive options for implant sizes. He notes that the implant is anatomically designed with left and right tibial trays, and adds that the tibial trays facilitate anatomic-shaped coverage extending around the lateral incisura.

Furthermore, the talar dome implant is chamfer cut, which Dr. Angirasa says preserves significant bone stock and reduces subsidence risk with minimal overall talar bone resection resection, and hopefully preserves the talar body vascularity.

“The chamfer cut of the talar dome has a simple, elegant design, eliminating the frustration typically found with other systems,” points out Dr. Angirasa.  

The articulating system mimics the conical flexion and extension of the ankle joint after proper placement, according to Dr. Angirasa. He notes anterior- and posterior-biased poly inserts accommodate talus sagittal plane subluxation, which ensures proper linear symmetry.  

“Any guessing or uncertainty is eliminated by the engineering design of this system,” says Dr. Angirasa.

Making An Impact In Reducing Bioburden

PuraPly AM (Organogenesis). Bioburden is an “incredibly common complication” that can negatively impact tissue repair and delay healing if it goes unaddressed, notes Ryan Fitzgerald, DPM, FACFAS. He says PuraPly AM (Organogenesis) can help address the challenges of bioburden in wounds.

Dr. Fitzgerald, a consultant for Organogenesis, notes that PuraPly AM, a bilayer, cross-linked native collagen product, has an intact structure and polyhexamethylene biguanide (PHMB), which can address matrix metalloproteinase (MMP) imbalance. He points out that PuraPly AM is unique as it combines purified native collagen with PHMB, which provides broad antimicrobial coverage and protects against a wide range of bacteria that colonize wounds and can progress to biofilm formation and infection.

PuraPly AM utilizes purified Type 1 native collagen matrix to create a durable biocompatible scaffold, according to the manufacturer Organogenesis. In addition, the company notes the wound matrix is an effective barrier against a wide array of microorganisms and PHMB can inhibit the formation of biofilm on the wound surface.

As Dr. Fitzgerald notes, PuraPly AM is approved for acute and chronic wound management across a variety of wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, venous ulcers and diabetic ulcers. He has used PuraPly for more than a year on more than 60 patients, noting patients tolerate it well and none have had any adverse outcomes.

“A lot of times, debridement alone isn’t enough to prevent the reformation of biofilm,” says Dr. Fitzgerald, an Associate Professor of Surgery at the University of South Carolina School of Medicine. “As part of a comprehensive biofilm-based wound management approach including sharp debridement, PuraPly AM provides a barrier that helps prevent biofilm re-formation and supports healing.”

Could A New Piscine Graft Improve Wound Healing?

Kerecis Omega3 (Kerecis). Wound care patients may experience enhanced healing with a new piscine graft.   

Kerecis Omega3 is the first in a new class of grafts derived from fish skin, according to Lee C. Rogers, DPM. He notes the graft, harvested from the abdomen of Atlantic cod, is cleared by the Food and Drug Administration for use in wounds and surgery.

Dr. Rogers notes that Kerecis is processed differently than virtually all other grafts derived from mammals. He adds that there are no known viruses that transmit from fish to humans. Dr. Rogers says piscine grafts maintain the native collagen structure and cross-linking, and also contain omega-3 fatty acid, a potent anti-inflammatory.  

“Since chronic wounds may be stuck in the inflammatory phase of healing, a graft which reduces inflammation has tremendous potential,” says Dr. Rogers, the Medical Director of the Amputation Prevention Centers of America and a Clinical Assistant Professor at the Western University of Health Sciences College of Podiatric Medicine.

Dr. Rogers also says Kerecis is less expensive than many other grafts on the market but use of the modality still receives high-tier reimbursement in hospital outpatient departments and wound care centers. He points out that the graft is also a useful alternative option for patients with certain religious objections to grafts using porcine, bovine or human tissues. The manufacturer Kerecis adds that the Omega3 technology can be helpful with skin reconstruction in burns and chronic wounds.

Dr. Rogers notes physicians should ensure the patient has a clean, uninfected, vascularized wound bed and should combine Omega3 with regular debridement and good offloading.

Addressing The Challenges With Preventing Venous Ulcer Recurrence

Extremit-EASE (AmerX Health Care). Venous leg ulcers have a very high rate of recurrence, according to Jeffrey Lehrman, DPM, FASPS. While compression garments can help prevent recurrence of these ulcers, Dr. Lehrman says the challenge is that patients have a very difficult time getting the compression garments on and often give up.

Dr. Lehrman calls the new Extremit-Ease compression garment a “game changer.” Extremit-Ease has zipper technology, allowing a user to open it all the way up, which he notes makes it very easy to apply. Just zipping up the garment provides 10 mmHg of compression and Dr. Lehrman notes patients can pull bungee straps, affixed with Velcro, to provide an additional 30 to 50 mmHg of compression, which patients can independently adjust for comfort.  

The manufacturer AmerX Health Care says the Extremit-Ease garments can be helpful in managing mild to moderate swelling from lymphedema, chronic venous insufficiency, acute postoperative edema and other disorders that cause swelling.

The ease of patient application “provides a huge advantage over traditional compression garments,” according to Dr. Lehrman, a Fellow of the American Academy of Podiatric Practice Management (AAPPM), who is in private practice in Pennsylvania. Further, he says patients can adjust each “zone” of the garment independently without removing the entire garment, which is helpful when patients are lying down or napping. He notes patients can also disengage the “zones” without the need to remove the entire device. Lastly, Dr. Lehrman says the structural design of the device helps to prevent pistoning, which is common with traditional compression garments.  

AmerX Health Care notes the compression garments consist of a fabric that is comfortable, lightweight and air-permeable. The company says the Extremit-Ease is available in a range of sizes and does not contain latex.

Dr. Lehrman says the Extremit-Ease modality should help to prevent recurrence of venous leg ulcers. The prevention of ulcer recurrence is critical for patients and providers as quality metrics and cost begin to factor into reimbursement, according to Dr. Lehrman. He also cites impactful practice management considerations with the product as it has its own HCPCS code. “Providers can dispense this (product) and enjoy considerable profits,” asserts Dr. Lehrman.

Dr. Lehrman notes that while the first model of Extremit-Ease provides compression only to the leg, the second-generation model is expected to include the foot as well.

Treating Heel Pain With An Emerging Modality

D-Actor 100 (Storz Medical/Medical Wave). Can an emerging acoustic wave therapy modality make an impact in treating heel pain?

With the D-Actor 100, Nicholas Romansky, DPM, FACFAS, says one can treat both chronic and acute heel pain in a non-invasive manner by addressing the underlying cause, not the symptom. He says the acoustic wave device uses high-energy sound waves to treat the lack of blood flow, chronic inflammation and scar tissue inherent with heel pain.

Dr. Romansky notes the D-Actor 100’s hand controls allow physicians to adjust the frequency, energy levels and degree of pressure applied. He says this permits safer treatment by making changes while not looking away from the patient. The D-Actor 100 also has deep impact pressure transmitters to accurately pinpoint deep pain regions, according to Dr. Romansky, a Fellow of the American College of Foot and Ankle Surgeons.

Dr. Romansky, who is in private practice in Pennsylvania, has used the technology for over a year. He uses it to successfully treat a myriad of conditions, including Achilles tendonosis, shin splints and patellar tendinitis, and cites a “high rate of success” in using acoustic wave therapy to treat plantar fasciitis. He adds that it takes about seven to 10 minutes to administer the therapy and that it is cost-effective, necessitating only three to five treatments.

“It garners better and faster results for plantar fasciitis than any other noninvasive modality or treatment available to me,” says Dr. Romansky, a Diplomate of the American Board of Podiatric Surgery.

Offering Patients Relief From Dry Skin

Epidermal barrier repair. A new technology may offer patients relief from dry and irritated skin.

Tracey Vlahovic, DPM, says clinicians can provide epidermal barrier repair through the use of emerging products that contain hyaluronic acid or ceramides or both as these products can penetrate the epidermis and moisturize the skin.

Dr. Vlahovic notes products with epidermal barrier repair reduce transepidermal water loss for patients with conditions like xerosis and inflammatory skin conditions, and also reduce flares associated with inflammatory skin conditions. She notes patients can use the non-steroidal therapy in conjunction with other medications or as monotherapy. Many of these products contain ceramides, hyaluronic acid and physiologic lipids that help restore and heal the stratum corneum, according to Dr. Vlahovic, a Clinical Associate Professor in the Department of Podiatric Medicine at the Temple University School of Podiatric Medicine.

Dr. Vlahovic cites several products that can facilitate epidermal barrier repair.

EpiCeram® Controlled Release Skin Barrier Emulsion (PuraCap Pharmaceutical) is a topical skin-barrier repair product that has an approved indication for atopic dermatitis. The company notes EpiCeram contains the essential lipids ceramide, conjugated linoleic acid and cholesterol.

HylatopicPlus (Encore Dermatology) can provide relief from the burning, itching and pain associated with atopic dermatitis, allergic contact dermatitis and radiation dermatitis, notes the manufacturer Encore Dermatology. The company adds that the lotion can treat dry skin by providing a moist environment.

Neosalus (Exeltis) can be helpful in managing various types of dermatoses such as atopic dermatitis and allergic contact dermatitis, notes Exeltis. The company notes the product’s free fatty acids penetrate beyond the stratum corneum to synthesize ceramides, cholesterol and other free fatty acids.

Ceramax (IntraDerm Pharmaceuticals) may be beneficial in managing the skin irritations and inflammation caused by atopic dermatitis and allergic contact dermatitis, notes the manufacturer IntraDerm Pharmaceuticals. The company says Ceramax consists of selected lipids and a lipid precursor, which can penetrate the bilayers of the skin by blending with the natural lipid building blocks.

Dr. Vlahovic notes the research and development of the aforementioned prescription products are superior to that of over-the-counter products. When prescribing epidermal barrier repair, she will use coupons and specialty pharmacies to get the product into the patient’s hands.  

A Cost-Effective, Efficient Option For Implant Surgery

FlowerCube (Flower Orthopedics). Surgeons can come prepared for any type of implant surgery with a line of products that bundles everything needed for a specific surgery in one self-contained package.

Patrick DeHeer, DPM, FACFAS, notes the implants and instruments in the FlowerCube package are single-use and sterile, resulting in reduced cost and improved efficiency. “Both of these factors are paramount in today’s healthcare market,” emphasizes Dr. DeHeer.

Dr. DeHeer, who has used the FlowerCube system for two years, says the system provides surgical instruments, cannulated screws and implants for forefoot, midfoot, hindfoot, fibula and tibia repair. He says the fact that the products are ready for use in surgical procedures eliminates the need for preoperative, on-site sterilization. In addition, Dr. DeHeer notes there is an environmentally friendly technology with FlowerCube, saving water, energy and packaging for sterilization.

The manufacturer Flower Orthopedics notes all instruments and implants that are required for specific surgeries are contained in secure shipping containers made of hard plastic. The company says the package includes the FlowerCarriage, made of medical grade laminate, which physicians can transport in and out of the operating room.

“Implant expenses are in the crosshairs for hospitals and surgical centers. Products that save time and reduce expense are a big deal. I think they are changing the market,” says Dr. DeHeer, who is in private practice with various offices in Indianapolis and is the founder of Step by Step Haiti.

Can A New Allograft Enhance Fixation For Small Bone Osteotomies?

AlloAid® Nail (In2Bones). An emerging allograft may provide more reliable fixation in small bone osteotomies.

The AlloAid® Nail has osteoconductive properties and is sterile cortical bone with a sterility assurance level of 10-6 SAL, according to the manufacturer In2Bones. The company says the allograft is engineered with multiple wedge facets that can anchor the nail in the bone.

Gary Lepow, DPM, FACFAS, an Associate Clinical Professor at both the Baylor College of Medicine and the University of Texas Medical School in Houston, has used the AlloAid Nail for several years without any complications.

As Dr. Lepow notes, AlloAid Nail is particularly beneficial in first metatarsal osteotomies such as the Austin or chevron bunionectomy.

In comparison with other fixation devices, Dr. Lepow cites several advantages of the AlloAid Nail allograft, including design, ease of application, strength, improved sizing and instrumentation.

In2Bones notes the AlloAid Nail is resorbable so there are no hardware concerns. The allograft comes in two diameters (2.3 mm or 2.8 mm) and three lengths ranging from 16 to 22 mm.

To read the top ten innovations of past years, see http://tinyurl.com/y8bs4228 .

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Brian McCurdy, Managing Editor
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