Top 10 Innovations In Podiatry

The past year was an unusual one for the world in general, with a global pandemic affecting everyday life, and certainly medical practice. However, despite those challenges, innovation in foot and ankle medicine and surgery continued to emerge, giving podiatrists new and exciting options to consider. Here thought leaders share their experience and insights on this year’s slate of innovative and impactful modalities.

Do Updates To Existing Procedures And Techniques Improve Outcomes?

Coronet^™ Soft Tissue Fixation System (CoNextions). Could a streamlined, sutureless approach prove superior for soft tissue fixation? According to the company, the Coronet Soft Tissue Fixation system’s design addresses the pitfalls traditionally associated with suture in these procedures. The tap-in, PEEK bone anchor engages the soft tissue and bone simultaneously and the electropolished soft tissue washer contributes to enhanced tear-through resistance. CoNextions adds that these components connect by a continuous loop of #2 ultra-high molecular weight polyethylene for additional security and gap resistance.

Lawrence DiDomenico, DPM, FACFAS, Director of Podiatric Residency Training at St. Elizabeth Health Center in Youngstown, Ohio, performed the first Kidner procedure with this new system and serves on the company’s Surgeon Advisory Board.

“It is easy to use, saves steps in the surgical process and does not require sutures when fixating soft tissue to bone,” he says. “I find that the system’s fixation is strong and secure with resistance to tear-through.”

The Coronet System provides a customized drill bit as part of a single-use kit. It comes pre-mounted on the disposable inserter. According to CoNextions, it is FDA-approved for fixation of tissue to bone and tissue to tissue in multiple anatomic locations including in the lower extremity. Also need to confirm any disclosures

Lapiplasty^® Mini-Incision^™ System (Treace Medical Concepts). Might a unique approach to an existing system enhance outcomes for bunion correction? The Lapiplasty Mini-Incision System aims to achieve “triplanar correction minus the compromise,” according to Treace Medical’s website. With a smaller, 3.5-cm dorsal incision, placement of the system’s Mini-Incision Positioner over the skin of the first metatarsal can assist surgeons in executing precise triplanar bunion correction in a minimally invasive fashion. The system also includes a Mini-Incision Cut Guide, a plate holder and a SpeedSeeker^™ positioner, which is both a fulcrum and joint-seeking instrument.

J.P. McAleer, DPM, FACFAS, with more than one year’s experience using the Mini-Incision System, says those already familiar with the traditional Lapiplasty technique are best suited to this new approach.

“It includes specialized instrumentation developed to realign the first ray without the need to fully dissect the proximal aspect of the metatarsal,” he says. “These innovations facilitate deformity reduction and work synergistically through a reduced incisional aperture.”

Citing the novel philosophy of the system, Dr. McAleer, who serves on the surgeon advisory board for Treace Medical Concepts, Inc., says that in his experience, it removes the need for free-handed, estimated bone cuts. Although he points out that the smaller incisional approach could increase dependence on intraoperative fluoroscopy (due to obstruction of surgeon vision), he adds that the hardware is specific to the unique regional anatomy.

“The Lapiplasty Mini-Incision System introduces the Plantar Power Plate which is a “U”-shaped, medial plate that helps to stabilize the inferior aspect of the first tarsometatarsal arthrodesis in order to reduce the risk for metatarsal elevation and plantar joint gapping,” says Dr. McAleer, a Fellow of the American College of Foot and Ankle Surgeons.

Autostrut G2 Robotic Hexapod System (OrthoSpin). Could a novel external fixation system be a postoperative breakthrough? FDA-cleared for use with DePuy Synthes MAXFRAME hardware, OrthoSpin says this fully-automated, hexagonal robotic system is compatible with existing treatment plans and does not require a change in procedure.

Jeffrey E. McAlister, DPM, FACFAS shares several months of experience with the G2 system, and feels such a breakthrough in technology only comes around every few years.

“It integrates artificial intelligence (AI) into a standard procedure,” he says. “It’s a true advancement in patient-centric care that allows us to create a consistent approach to a complex problem.”

In his experience, he finds the G2 system to be patient-friendly and a faster, more efficient external fixation device for deformity correction, says Dr. McAlister, in practice at the Phoenix Foot and Ankle Institute.

The OrthoSpin website details that the system replaces traditional mechanical struts with motorized struts, eliminating manual adjustments in favor of a robotic, hands-free system. They add that the system is IP68 waterproof, allowing patients to shower, bathe and participate in therapeutic water exercise.

The company says the system has compatibility with 90 to 270 mm rings and autoclave sterilization, removable duty gear motors and multiple strut sizes.

How Might Advances In Wound Treatment Contribute To Limb Salvage?

ActiGraft^® (RedDress Medical). Could wound care providers create a natural wound healing environment using a patient’s own blood? ActiGraft is an FDA-cleared option that allows for real-time generation of in vitro blood clot tissue to act as a protective and supportive wound covering, says RedDress Medical. They go on to say that the dressing, which contains fibrin matrix derived from the patient’s drawn blood, can support every stage of wound healing, including hemostasis, inflammation, proliferation and remodeling. The company shares that one can prepare the dressing at bedside and integrate this modality into other chronic wound care practices.

Robert J Snyder, DPM, MBA, MSc, CWSP, FFPM RCPS (Glasgow) has over five years experience with this product and is a consultant for RedDress Medical. He shares that this autologous blood clot therapy contains growth factors, macrophages and substrates needed to support closure.

“Additionally, this therapy acts as a vehicle to replace extracellular matrix components,” he says, “thus stimulating dynamic reciprocity. This innovative technology utilizes the body’s own defenses to give the wound ‘what it needs when it needs it’ while fostering the attraction and incorporation of many cells such as keratinocytes and fibroblasts.”

One draws a small amount of blood, injects it with calcium gluconate and then places it in a ‘dome’ where it quickly forms a clot which one fastens to the site with steri-strips, says Dr. Snyder, Dean, Professor and Director of Clinical Research at Barry University School of Podiatric Medicine in Miami Shores, Fla.

“As long as the patient has venous access, I find Actigraft is simple to use, evidence-based and cost efficient,” he adds.

SonicOne^® O.R. (Misonix). According to the company, the SonicOne O.R. is the first and only debridement tool that combines ultrasonic debridement with aspiration. They share that the technology provides accurate debridement without damage to sensitive structures. The system maximizes wound bed preparation, lysing biofilm and preserving healthy tissue while reducing blood loss, they add. The system also has multiple available debridement tip styles that will accommodate various types of wounds.

Lee C. Rogers, DPM, FFPM RCPS (Glasg) has used the SonicOne O.R. since its release in 2020.

“The ultrasonic tip oscillates at 22,500 per second, disrupting biofilm and destroying bacterial cell walls,” he explains. “Additionally, sharp ultrasonic debridement technology discriminately breaks up fibrosis and necrosis while having a positive modulating effect on healthy tissue.”

He adds that part of the goal of any debridement is to reduce bacterial contamination and remove unwanted tissue.

“Sharp ultrasonic debridement fits nicely in the clinical practice pathway for wound management,” says Dr. Rogers, President-elect of the American Board of Podiatric Medicine. No other products or systems combine ultrasonic surgical debridement and aspiration. The initial product is limited to the O.R., but expansion to the clinic outpatient setting is planned soon. Dr. Rogers notes that he serves as an advisor to Misonix.

VACOcast^® Diabetic Boot (OPED Medical). Could a newer offloading boot address some drawbacks to total contact casting? According to OPED Medical, the VACOcast Diabetic Boot provides comfort and stability with a vacuum insert cushion that molds to the foot and allows for weight bearing. They say the high boot shaft improves stability and reduces friction, and washable liners allow for patient hygiene. It’s four-strap system also adds to the stability, and there are optional locks and compliance seals available, according to the product website.

Windy Cole, DPM, CWSP, Adjunct Professor and Director of Wound Care Research at Kent State University College of Podiatric Medicine, shares that over one to two years of using the product, she finds it to be an option for clinicians reluctant to implement total contact casts (TCCs) in their practices.

“Although researchers and consensus bureaus alike have long considered TCC to be the gold-standard offloading device, there is still a gap in clinical use,” she explains.

The ability to unlock the boot to access the wound is a significant feature, according to Dr. Cole, who also cites the locking mechanism as a treatment adherence promoter.

“One of the many advantages of this device is the rocker sole, allowing the patient a safer and more normal gait pattern than other offloading devices, in my experience,” she says. “The liner also covers the toes to prevent debris from entering the boot. An added foam bed layer allows for increased shock absorption and optimal pressure distribution.”

Dr. Cole notes that she is the lead investigator in a trial comparing the use of this product versus total contact casting in the treatment of plantar surface DFUs, which OPED Medical sponsors.

Might New Options Improve Outcomes And Ease Challenges For The Surgeon?

CoLink^® Bone Graft Harvester (In2Bones). According to In2Bones, the CoLink Harvester allows surgeons to enhance bony healing of fractures and fusions by morselizing harvested cancellous bone into chips as part of a sterile, single-use kit. One can use the company’s Tribio^™ Backfill Plugs (5.5 x 40 mm and 7.5 x 40 mm), which one can cut to length, to stimulate bone regeneration in any voids left by the harvester.

“I typically take these grafts from the calcaneus and find the harvester easy to use,” says Lawrence DiDomenico, DPM, FACFAS, Program Director of the Reconstructive Rearfoot and Ankle Fellowship at NOMS Ankle and Foot Care Centers in Youngstown, Ohio.

In2Bones shares that the CoLink Bone Graft Harvester comes in six- and eight-mm outer diameters. The inner trough holds the morselized bone after harvest. According to the website, through a minimally invasive technique, at low speed, surgeons drill to the desired depth in the bone after proper exposure, taking care to remain in the cancellous bone.

Thomas Roukis, DPM, PhD, FACFAS has used the CoLink Bone Graft Harvester system since its release.

“The system is a single-use item that is readily available off the shelf when needed and the sterility is a certainty,” he says. “The entry reamer is very sharp and easily penetrates the cortical wall of the lateral calcaneus, as well as, medial, distal and proximal tibia.”

He says that he finds the system provides ample graft volume, with a time-friendly technique. Dr. Roukis, a Professor of Orthopaedic Surgery and Rehabilitation in the Division of Foot and Ankle at University of Florida Health, Jacksonville, also points out that with reusable instruments, sterility is not guaranteed. The resultant cost of cleaning, repackaging, sterilizing, restocking and paying employees to do so makes the CoLink Bone Graft Harvester a good value as well, in his opinion.

Phantom ActivCore^™ Nail System (Paragon 28). This emerging option for tibiotalocalcaneal fusion and tibiocalcaneal fusion offers constant postoperative compression that accommodates up to eight mm of bone resorption across the joints, according to Paragon 28. They also share that the nail has an outer sheath with a proximal Flex Coil design and inner sliding core, with eleven different size options available. Specifically, the Flex Coil design contributes to stress sharing within the contoured anatomy of the tibia, says the company.

Byron L. Hutchinson, DPM, FACFAS who has used this nail since its launch several months ago, feels the stress-sharing feature within the tibia allows him to have less concern about possible tibial fracture, especially with longer nails.

According to the product website, the system’s reproducibility stems from the PRECISION® guide technology, which allows for precise placement of the initial drill pin, determining implant trajectory from distal to proximal. The parallel offset guide provides flexibility for surgeons to place an additional drill pin four mm in any direction if they prefer an alternate trajectory of the nail. The 7.2 mm threaded calcaneal peg offers variable angles of placement from zero to 18 degrees, improving bony purchase tailored to a patient’s anatomy.

Paragon 28 adds that surgeons implant the Phantom ActivCore nail through their carbon fiber Phantom^® Ghost^™ Outrigger apparatus. Its radiolucent inlay features allow surgeons to visualize the pegs’ direction and placement under fluoroscopy before they drill. Overall, the website adds that the Phantom Hindfoot TTC/TC System carries a comprehensive array of instrumentation for joint preparation in these cases, including cartilage removal tools, curettes, osteotomes, burrs, perforators and bone fenestration chisels.

“The nail can be used for a TTC fusion but also can accommodate a situation where there is no talus, such as a total ankle replacement (TAR) explant or diabetic Charcot where the talus is gone,” says Dr. Hutchinson, Medical Director of the CHI/Franciscan Advanced Foot and Ankle Fellowship in Federal Way, Washington.

What Newer Options Exist For Customizable Insoles And Skin Closure?

CURREX Sport-Specific Insoles (CURREX). Each sport and activity is biomechanically unique. A growing insole company recognized this concept and dedicated themselves to the development of cutting-edge technology to maximize their product across a multitude of users. According to the company website they created their line of insoles to be specific to the movements one encounters in each individual activity, such as running, soccer, skiing, hiking, biking, tennis, hockey and golf.

Across the entire line, CURREX shares that two primary unique features of their insoles, designed by German sports scientists, are their patented Dynamic Arch Technology (DAT) and arch customization. Dynamic Arch Technology allows flexibility in the device balanced with appropriate rigidity, creating sensory stimulation and midfoot guidance. They continue to say that this stimulation could reduce stress on musculoskeletal structures and help avoid injury. Three different arch profiles are also available for each style of device, which one combines with knee alignment to find the optimal fit. CURREX shares that the devices also feature a deep, decoupled heel cup to wrap and lock around the heel, a Poron^® heel cushion for enhanced shock absorption and a bamboo, moisture-wicking midlayer with charcoal for odor control.

HEMIGARD^® Adhesive Retention Suture Device (Suturegard Medical). Could a new device help surgeons better close acute wounds under tension? According to the manufacturer, the HEMIGARD ARS allows high-tension, linear wound closure without skin tearing by bolstering skin strength. Three zones of action, each with varying stiffness, provide different characteristics that contribute to its goal.

David Sipala, DPM, FACFAS says, in his opinion, HEMIGARD has revolutionized his approach to cases of poor tissue quality in limb salvage over the past year.

“(It is a) great tool to provide better protection for my primary closures and more assurance that delayed healing or dehiscence will be prevented,” he explains. “Therefore, more radical resection and use of skin flaps and/or grafts are not necessary. It has provided me confidence in many of my closures, decreasing the need for multiple trips to the operating room, less NPWT applications, and decreased hospital readmissions.”

Dr. Sipala, a clinical consultant for HEMIGARD, cites the adaptability and versatility of the device in providing a multitude of ways of applying the device along a surgical site and facilitating more efficient closure. He goes on to say that he now uses it in many of his elective cases as well.

“(HEMIGARD) is optimizing an ideal environment for healing by decreasing tension, maintaining perfusion and promoting closure,” he adds. Also need to confirm any disclosures

Arun Karwal, DPM first used HEMIGARD in January and has since become a firm believer in the technology. He says his finds it very effective in reapproximating high tension wounds and decreasing wound dehiscence. Initially he shares his interest lied in its use for amputation cases, but this quickly evolved into applications for his trauma cases and other high-risk incisions.

“In the past, I’ve used retention sutures, vessel loop closure and NPWT, but there is nothing like HEMIGARD which assists my primary closure with good cosmetic results,” says Dr. Karwal, who is also a consultant for HEMIGARD.

He concludes by saying he likes to think of the device as a seat belt over his incisions, which allows earlier weight bearing and range of motion.