In our annual roundup of new and emerging innovations, this author talks to thought leaders in the field to get their perspectives on advances in podiatric surgery, promising modalities in lower extremity wound care and much more.
Could a new cellular- and tissue-based product carve out a significant role in the armamentarium for diabetic foot ulcers? Will emerging alternatives to common hammertoe implants be game changers? Could a promising new therapeutic option reinvent the treatment of lower extremity warts? Leading podiatrists share their thoughts on these questions and offer insights on a variety of emerging products and technologies.
• TenoTac™ Soft Tissue Fixation System (Paragon 28). The challenges with tendon transfers reportedly include obtaining adequate anatomical exposure, tunneling of suture and maintaining the intended correction postoperatively. That said, when it comes to repairing contracted toes and stabilizing the metatarsophalangeal joint, Patrick DeHeer, DPM, says the digital flexor tendon transfer has remained a time-honored procedure over the past century but without any significant technique advances until now.
As an alternative to traditional flexor tendon transfers, the TenoTac Soft Tissue Fixation System enables surgeons to balance plantar and dorsal tension, facilitating correction without the release of tissue attachments distally, according to Paragon 28, the manufacturer of the TenoTac system.
“The TenoTac (system) changes the approach, lessens the dissection and simplifies the procedure for predictable results and less swelling,” notes Dr. DeHeer, who is board-certified in foot surgery and reconstructive foot and ankle surgery by the American Board of Foot and Ankle Surgery.
Paragon 28 says the TenoTac system offers a titanium threaded implant and a simple insertion approach for surgeons to obtain optimal fixation. After prepping the phalanx and inserting the plantar implant component into the bone tunnel, Paragon 28 says surgeons can subsequently achieve temporary fixation and correction by holding manual tension over the tendon and bone. After achieving the correction, the surgeon threads the dorsal and plantar components of the implant together, according to Paragon 28.
Michael Downey, DPM, FACFAS, calls the TenoTac Soft Tissue Fixation System a unique fixation option for “tacking” a flexor tendon to a phalangeal bone.
“In my opinion, this fixation is ideal for use in Girdlestone-Taylor procedures (i.e. flexor tendon transfers) in which one is transferring the flexor digitorum brevis tendon or the flexor digitorum longus tendon to the proximal phalangeal base,” says Dr. Downey, Chief of the Division of Podiatric Surgery and Medicine at Penn Presbyterian Medical Center of the University of Pennsylvania in Philadelphia. “The lesser digital flexor tendon transfer remains a viable surgical option in plantar plate insufficiency, especially when the plantar plate is attenuated or of poor quality for direct or indirect repair.”
Dr. DeHeer, the Podiatric Residency Director at St. Vincent Hospital in Indianapolis, concurs about the unique nature of the TenoTac system.
“There are many other hammertoe implants available but they all function as internal interphalangeal joint fusion devices,” points out Dr. DeHeer, who discloses that he is a speaker for Paragon 28. “The TenoTac can be used with other devices if arthrodesis/fusion is necessary in order to repair a contracted toe. (Surgeons can use) the device alone for a flexible or semi-rigid deformity repair as well. Many of the digital implants have a 10 degree plantarflexion option so if the proximal interphalangeal joint is in slight plantarflexion, the TenoTac is still a viable option.”
• FlexBand™ (Artelon). For surgeons looking for adjunctive modalities to facilitate ligament and tendon reconstruction in foot and ankle surgery, FlexBand may offer unique promise.
Artelon, the manufacturer of the product, says FlexBand provides a dynamic proprietary biotextile matrix that is 1.2 mm thick and comprised of polycaprolactone and polyurethane-urea co-polymer fibers.
Christopher Hyer, DPM, FACFAS, who has used the FlexBand product for two years, has found it beneficial in chronic tendon tear augmentation and extra-articular ankle ligament reconstructions.
“The FlexBand allows for ligament and tendon soft tissue augmentation with a scaffold that is robust and strong, but also has some stretch and recoil similar to native tissue,” notes Dr. Hyer, the Co-Director of the Orthopedic Foot and Ankle Center Fellowship at the Orthopedic Foot and Ankle Center in Westerville, Ohio.
Dr. Hyer adds that FlexBand comes in two useful lengths that are helpful in weaving and reapproximating native structure.
Nicholas Romansky, DPM, FACFAS, says the FlexBand product has a “tensile strength unlike any other product on the market.”
Dr. Romansky, who has used the product for more than two years, notes “excellent results” in utilizing FlexBand in Achilles tendon and lateral ankle stabilization procedures. The team podiatrist for the U.S. World Cup and U.S. Men’s and Women’s National Soccer Teams, Dr. Romansky says FlexBand provides an “instant stability” upon application.
In addition to strength and elasticity, Artelon notes the FlexBand offers the porosity that is essential for regenerative ingrowth as well as a four- to six-year dissolution rate.
A New ‘Standard’ For Hammertoe Surgery?
• ExoToe™ Hammertoe Correction System (Surgical Design Innovations). For surgeons looking for a hammertoe implant that reportedly preserves the bony canal, the ExoToe Hammertoe Correction System may provide a viable option as an extramedullary device that preserves medullary bone.
Surgical Design Innovations, the manufacturer of the device, says the ExoToe allows interoperative anatomic angle adjustability, provides augmented fixation in comparison to K-wires alone and enables surgeons to combine the implant with K-wire to stabilize the metatarsophalangeal joint (MPJ).
“(The ExoToe) is an alternative to intramedullary devices used in hammertoe surgery and it has an innovative design to be external to the bone rather than internal,” explains Troy J. Boffeli, DPM, FACFAS, who is board-certified in foot surgery and reconstructive rearfoot and ankle surgery by the American Board of Foot and Ankle Surgery. “Intramedullary (IM) devices limit the use of K-wires, which are often desired to stabilize the MPJ. IM devices are nearly impossible to remove in the event of complications while the ExoToe implant captures the fusion site on the exterior of the bone, allowing easy removal.”
Dr. Boffeli says the ExoToe procedure is quick and the implant is easy to apply.
“The surgeon can do his or her standard hammertoe fusion procedure with no modifications. Once the proximal interphalangeal joint is pinned, the ExoToe implant is placed beneath the extensor tendon around the exterior of the bone and crimped in place,” notes Dr. Boffeli, who is the Residency Director of the Foot and Ankle Surgical Program at Regions Hospital/HealthPartners Institute for Education and Research in St. Paul, MN.
Dr. Boffeli, who discloses that he was a consultant with the manufacturer in the late stages of the device’s development, anticipates that the ExoToe will become his “standard approach for hammertoe surgery.
Surgeons may utilize the ExoToe system as a primary hammertoe implant or for hammertoe revision cases, according to Surgical Design Innovations.
A Closer Look At A Promising Wart Therapy Treatment
• Swift® Microwave Therapy (Emblation). If you are looking for a new way to treat warts that is cleaner, more precise and quicker with minimal patient prep, Swift Microwave Therapy may warrant a closer look.
Unlike common wart treatments such as cryotherapy, salicylic acid and laser ablation that break the skin surface and destroy tissue from the point of application, Swift Microwave Therapy enables clinicians to deliver a targeted and controlled low dose of microwave energy to a pre-determined depth in the skin, according to Saorsa, the distributor of Swift Microwave Therapy in the United States. Saorsa adds that the design of the device ensures that the delivery of the microwave energy is in straight lines and does not have the lateral spread that one may see with cryotherapy treatment.
Tracey Vlahovic, DPM, who has used the device since January 2019, praises the unique and efficient nature of the modality.
“(Swift Microwave Therapy) is a portable and efficient system that applies microwave therapy to warts for approximately 10 seconds,” notes Dr. Vlahovic, a Clinical Professor in the Department of Podiatric Medicine at the Temple University School of Podiatric Medicine. “It is a novel therapy and there is nothing else for warts that uses this modality.”
Saorsa also notes that with the Swift Microwave Therapy, there is no anesthetic, minimal debridement, no post-procedure smoke and no post-procedure dressing. The company also says there is no evidence of scarring.
Dr. Vlahovic says patients may have brief pain during the procedure but she notes that most of her patients report less post-procedure pain than what they had initially had with the wart.
Promoting Improved Stability And Comfort With An External AFO
• TayCo External Ankle Brace (TayCo Brace LLC). While there are a variety of ankle foot orthoses (AFOs) and braces on the market, Dr. DeHeer says the TayCo External Ankle Brace is the only external stability AFO for functional ankle treatment.
Dr. DeHeer, who has used the product for over a year, says the TayCo External Ankle Brace provides “excellent stability” while allowing patients to comfortably use their own jogging shoes or work boots. With the TayCo brace fitting over the shoe, Dr. DeHeer says this eliminates overcrowding of the brace in the shoe (allowing for less restrictive shoe options) and reduced pressure points that cause irritation due to bony deformities.
The TayCo External Ankle Brace also provides a viable lightweight alternative (typically 12 ounces) to the cast boot (ranging from two to four pounds), according to Dr. DeHeer, a Diplomate of the American Board of Podiatric Surgery. He also notes that cast boots can cause leg length discrepancies that can lead to secondary back, hip and knee problems. In his experience, Dr. DeHeer says the TayCo brace allows a “much quicker functional recovery” for work, shopping, playing, etc.
Dr. DeHeer notes that clinicians should not use the TayCo External Ankle Brace for conditions such as spasticity, severe dropfoot and severe ankle deformity.
Can Emerging Advances In Wound Care Have An Impact?
• SkinTE™ (PolarityTE). Derived from a patient’s own skin, SkinTE is a cellular and tissue-based product clinicians can use to regenerate full-thickness functional skin, according to the manufacturer PolarityTE.
The results of a pilot trial assessing the use of SkinTE for diabetic foot ulcers (DFUs) were presented at the American Diabetes Association’s 79th Scientific Sessions in June 2019. After one application of SkinTE, 10 of 11 patients with DFUs had healed wounds at eight weeks with a mean time to heal of 29.7 days, according to PolarityTE. (For more info on the pilot study, see “Can An Autologous Homologous Skin Construct Have An Impact For Diabetic Foot Ulcers?” in this issue.)
David G. Armstrong, DPM, PhD, MD, the principal investigator on two ongoing studies of SkinTE for DFUs and venous leg ulcers, calls SkinTE an “interesting and potentially exciting technology.”
“While there is much yet to learn about this technology and technique, (SkinTE) seems to behave like a hybrid between a split-thickness and full-thickness graft when mature,” notes Dr. Armstrong, a Professor of Surgery at the Keck School of Medicine at the University of Southern California, and Co-Director of the Southwestern Academic Limb Salvage Alliance.
Dr. Armstrong says SkinTE currently is a two-stage process, which begins with the initial harvest of a small piece of full-thickness skin and fat. Clinicians send that to PolarityTE for processing and the treating clinician subsequently applies the processed material (SkinTE). These procedures are usually scheduled two days apart, according to Dr. Armstrong.
Dr. Armstrong says an innovative aspect of SkinTE is that the procedure may eventually be done entirely in the clinic setting.
“This is in contradistinction to split-thickness or full-thickness skin grafts that require an operating room or procedure room,” notes Dr. Armstrong.
PolarityTE says physicians may employ SkinTE to repair, reconstruct, replace or augment a patient’s damaged or missing skin tissue.
• Debritom+ (Medaxis). For more precise debridement of lower extremity wounds in a tissue-preserving manner, podiatrists may want to assess Debritom+ (Medaxis), an emerging micro water jet modality expected to debut in the U.S. in July 2019.
Stephanie Wu, DPM, MSc, FACFAS, has been using Debritom+ since the beginning of April and notes the faster debridement time and tissue-preserving ability of the device.
“The pressure imparted on the wound is only sufficient to remove the necrotic tissue and fibrin with the granulating tissue being unharmed. (Debritom+) is more precise and can be carried out with less tissue damage than other mechanical methods,” says Dr. Wu, an Associate Dean of Research, a Professor of Podiatric Surgery and Applied Biomechanics, and Director of the Center for Lower Extremity Ambulatory Research (CLEAR) at the Dr. William M. Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science.
Medaxis notes that clinicians can utilize Debritom+ in both in-patient and outpatient settings. The company also points out that one can perform this debridement with the patient having no anesthesia or local anesthesia.
“The sensate patients whom we have tried the device on reported no to minimal pain and prefer (Debritom+) over traditional sharp debridement methods,” points out Dr. Wu.
Medaxis says Debritom+ is indicated for diabetic foot syndrome, decubitus ulcers, infected acute wounds, venous and arterial leg ulcers, and burn wounds.
• Endoform® Antimicrobial (Aroa Biosurgery /Appulse Medical). For clinicians looking for answers to help expedite the healing of chronic wounds, the extracellular matrix Endoform Antimicrobial may offer a variety of benefits.
According to the manufacturer, Endoform Antimicrobial is a natural intact collagen scaffold with 0.3% ionic silver, which gives patients a wide spectrum of antimicrobial protection as well as extended antimicrobial protection for up to seven days.
Nooshin Zolfaghari, DPM, who used the product for a year, notes a “rapid response” in facilitating wound healing within a couple of weeks after application of Endoform Antimicrobial.
“The advantage is Endoform Antimicrobial is not only an extracellular matrix, it’s an antimicrobial product that helps heal wounds that are colonized with bacteria and reduces the risk of infection,” says Dr. Zolfaghari, who is in private practice at multiple locations in Florida.
Igor Zilberman, DPM, who is in private practice in Ft. Lauderdale, Fla., has also had “great results” with the product in his experience and cites benefits such as easy application by clinicians and non-clinicians, long wear time, affordability and the ability to apply Endoform Antimicrobial on deep structures down to tendon and bone.
Dr. Zilberman says the product is contraindicated for those with an allergy to silver or ovine products. Dr. Zolfaghari notes that Endoform Antimcrobial “works well with well perfused wounds” and is contraindicated for ischemic wounds and active infections with purulent drainage.
The manufacturer says Endoform Antimicrobial is indicated for a variety of wounds including partial- and full-thickness wounds, pressure ulcers, diabetic ulcers and traumatic wounds.
Assessing The Potential Of New Surgical Modalities
• Salvation™ 2 Midfoot Nail (Wright Medical). For surgeons looking for an alternative fixation option in Charcot reconstructive surgery, the recently launched Salvation 2 Midfoot Nail may be an intriguing modality.
The 8 mm intramedullary device features cross-locking technology that has anti-migration benefits and is capable of providing up to 8 mm of controlled compression across fusion sites, according to Wright Medical, the manufacturer of the device.
Dr. Hyer, who has used the Salvation 2 Midfoot Nail in several cadaver labs, says it could be a significant advance in Charcot reconstruction.
“It is a midfoot Charcot nail that is similar to the concept of TTC nailing. The (Salvation 2 Midfoot Nail) has significantly increased strength over and above current beams and screws used in Charcot medial column fusion procedures,” notes Dr. Hyer, who is board-certified in foot and ankle reconstructive surgery.
Wright Medical says a cannulated technique and streamlined instrumentation facilitate ease of application for complex pathologies.
• 5th Metatarsal Fracture System (Arthrex). For tricky fifth metatarsal fractures, having a variety of fixation options and the relevant instrumentation within one package may facilitate more efficient procedures and optimal outcomes.
Dr. Downey says the Arthrex 5th Metatarsal Fracture System provides this kind of one-stop shopping.
“It is a nice, consolidated group of screws and plates for the fixation of just about any fifth metatarsal fracture,” emphasizes Dr. Downey, a senior faculty member of the Podiatry Institute.
The system allows for the percutaneous placement of a guidewire and subsequent percutaneous drilling, tapping and measuring for the placement of an intramedullary screw, according to Dr. Downey. He notes that the surgeon subsequently removes the guidewire and inserts a “solid” screw with a low-profile head percutaneously into the pre-drilled and pre-tapped hole.
“If the fracture is comminuted or too small for a screw, the tray also includes a hook plate with a compression slot, which allows for open fixation of those fractures as well,” points out Dr. Downey, a Clinical Professor and past Chairman of the Department of Surgery at the Temple University School of Podiatric Medicine.
Arthrex, the manufacturer of the Fifth Metatarsal Fracture System, says the system also features robust 4.5 mm, 5.5 mm and 6.0 mm screws, and cannulated drills and taps to facilitate accurate placement and efficiency.