Innovations in podiatric care may reduce the risk of post-op complications, improve wound healing outcomes or facilitate enhanced pain management. With this in mind, this author talks to leading physicians about key innovations including a new hammertoe implant, an emerging total contact cast, plating systems and a promising non-invasive pain management device.
New systems for hammertoe surgery and Lapidus plating. A new wound care dressing and an allograft for wounds. A device to help patients in pain get some sleep. Without further delay, here is what expert physicians have to say about new and emerging podiatry products.
Lync (Novastep). With a new one-piece hammertoe system, surgeons can achieve compression with accurate device placement. The Lync is composed of titanium and the manufacturer Novastep says its insertion tapers and migrant resistant talons permit stable purchase of bone.
The Lync features a single-piece, bifocal, barbed leg configuration that provides two zones of compression, notes Thomas Roukis, DPM, PhD, FACFAS, the Immediate Past President of the American College of Foot and Ankle Surgeons. He says the device requires no refrigeration and is specifically designed for small bone intramedullary insertion. Novastep adds that surgeons do not need guide wires for medullary canal preparation and Lync insertion.
Dr. Roukis says the Lync takes advantage of the manufacturer’s cleanSTART single-use sterile technology, which has double nested-tube packaging.
“(The cleanSTART technology) greatly increases the efficiency of my staff and their ability to control, track and trace inventory,” adds Dr. Roukis, an attending foot and ankle surgeon within the Department of Orthopaedics, Podiatry and Sports Medicine with the Gundersen Health System in La Crosse, Wis.
After one removes the outer tubes of the Lync, Dr. Roukis says a holder retains the sterile implant and permits direct implant to instrument transfer. He also says the tubes are organized by a customizable dispenser unit that contains enough implants to cover multiple surgeries. “The dispenser functions like a mini-vending machine, consuming minimum space outside of the sterile field and completely eliminates the need for any caddies,” says Dr. Roukis.
Dr. Roukis adds that Novastep’s forefootCOMPLETE and forefootEXACT tray platforms add convenience and efficiency to the OR experience. As he says, the forefootCOMPLETE has an intuitive layout with interchangeable, implant-specific modules and a compatible, universal instrumentation compartment that allows him to utilize the company’s hammertoe, staple and headless/snap-off screw implants from a single tray. In addition, the forefootEXACT is a much smaller tray that Dr. Roukis says provides the flexibility to customize his tool kit for a specific procedure. He notes it includes a built-in partition for the universal instruments along with a docking bay that accepts any of their implant-specific instrument modules.
“Novastep is ahead of the curve when it comes to implant, instrument and delivery innovation,” says Dr. Roukis. “Everything the company is coming up with will have a dramatic, positive impact on how we operate at our hospitals and surgery centers.”
As Thomas Rocchio, DPM, notes, the SonicAnchor Bioresorbable Anchoring System is composed of a biodegradable polylactide polymer. Dr. Rocchio explains that ultrasonic energy liquefies the polylactide implant, causing it to flow into the cancellous bone cavities in a process referred to as bone welding. As it quickly solidifies, this implant becomes an incredibly stable fixation device, according to Dr. Rocchio.
“This product’s long resorption time and excellent biocompatibility have made issues such as sterile abscess and foreign body reaction seen with other biodegradable products nonexistent in my significant experience with this material,” notes Dr. Rocchio, a Fellow of the American College of Foot and Ankle Surgeons.
The manufacturer Stryker notes that the SonicAnchor promotes 95 percent enhancement of dynamic load stability without the presence of cortical bone.
In the last three years, Dr. Rocchio has implanted hundreds of SonicPin (Stryker) devices, which is composed of the same material and fixates the osteotomy utilizing the same welding process that stabilizes the SonicAnchor. He claims he has never had a non-union, foreign body reaction or radiographic cystic change with these procedures. He notes the product is approved for fixation of the Austin/chevron osteotomy in bunion correction. Dr. Rocchio adds that the sonic cancellous fixation device has a low to zero profile, the stability of a bicortical screw and eliminates possible return to the operating room for fixation removal.
Dr. Rocchio, who is in private practice at PA Foot and Ankle Associates in Pennsylvania, notes that one downside to the sonic technology is that with the current approved use, there needs to be cancellous bone present at the fixation site. While noting there are techniques that offer possibilities of excellent anchor ability in anatomy with little to no cancellous bone and only cortical bone such as the shaft of long bones or in the presence of subcortical cysts, Dr. Rocchio says more research and testing are needed.
Gorilla Recon Plating System (Paragon 28). A new plating system combines technology and precision for a variety of surgical procedures. The Gorilla Recon Plating System has 10 subsystems and more than 20 plate styles, including patented Precision Guide plates for the Lapidus procedure, according to the manufacturer Paragon 28.
Patrick DeHeer, DPM, FACFAS, has used the Gorilla Recon Plating System for the past few months, citing it as a “very innovative” fixation device for first metatarsocuneiform arthrodesis.
“It provides fixation on both medial and lateral aspects of the joint, combining a compression screw laterally and a compression locking plate medially,” says Dr. DeHeer, who has multiple offices in Indianapolis.
The Gorilla plate prevents the plantar gapping of the dorsal medial plates and Dr. DeHeer says the medial pull of a straight medial plate reduces the deformity correction. He emphasizes that compression on both sides of the plate provides excellent rigid fixation and allows for earlier weightbearing, and possibly even immediate weightbearing. Dr. DeHeer says he emphasizes two weeks of non-weightbearing initially for these patients, transitioning to partial weightbearing in a cast boot and the use of crutches or a walker for the next two weeks with subsequent assisted weightbearing in a cast boot.
Paragon 28 notes that the Gorilla Recon Plating System uses Tuffnek Technology with a tapered neck to increase bending strength, optimized shaft balances and double lead thread. The company also offers various sizes of Gorilla Screws in locking and non-locking styles.
Dr. Roukis cites favorable experiences using the CrossTIE, a simple one-piece implant design precision manufactured from polyether ether ketone (PEEK), a thermoplastic polymer. He points out that the CrossTIE surgical approach only requires one drill bit to perform the procedure and features a transverse hole in the distal aspect of the implant. Dr. Roukis notes the CrossTIE’s transverse hole in the implant is unique and an asset when reducing the joint.
Dr. Roukis says many hammertoe implants have barbs, threads or expanding grippers that try to prevent pistoning of the implant. The simple answer, he advises, is to place a suture through the transverse hole and use the suture to hold the implant and reduce the joint, creating a tight fusion line. According to the manufacturer CrossRoads Extremity Systems, leaving the suture in with this technique is pending FDA approval as this issue went to press.
The company notes that the CrossTIE’s distal suture hole can aid in joint reduction and adds that the device is available in 0 and 10 degrees.
The company adds that the CrossTIE features an EcoSMART Instrument Recovery System. Dr. Roukis says having all the instruments and implants available sterile saves the facility the time and money associated with preparing surgical trays.
Dr. Roukis cautions that the CrossTIE implant depends on a press fit and that selecting the appropriate precision reamer is key. He notes the implant is not cannulated.
Variable Angle LCP Medial Column Fusion Plates (DePuy Synthes). “Medial column arthrodesis can be a technically demanding procedure and many of the options prior to this system were inadequate in my opinion,” says Dr. DeHeer, a Fellow of the American College of Foot and Ankle Pediatrics and member of the APMA Board of Trustees.
On the contrary, Dr. DeHeer says the 3.5 mm Variable Angle LCP Medial Column Fusion Plating System provides enough bulk with large enough screws to provide the stability and rigidity required. He notes the modality consists of a locking compression plate system with an external compression clamp.
The Variable Angle LCP system has advanced stabilization for fusion, particularly for the Charcot foot, according to the manufacturer DePuy Synthes. The company notes surgeons can use this plating system to independently compress each joint through the plate via forceps, 2.8 mm wires and posts. In addition, DePuy Synthes says the product’s variable angle locking technology allows surgeons to adapt screw trajectory to patient anatomy and target specific areas of cortical bone.
“Arthrodesis of multiple medial midfoot joints can be very difficult to fixate individually and other plating systems are just not robust enough, and do not allow segmental compression within the plate,” notes Dr. DeHeer.
Emerging Advances In Wound Care
Grafix (Osiris Therapeutics). As an alternative to autologous skin grafts, physicians may use the three-dimensional matrix allograft Grafix for acute and chronic wounds such as diabetic foot ulcers, according to the manufacturer Osiris Therapeutics.
A recently published multicenter trial by Lavery and colleagues comparing Grafix to standard wound care for the treatment of diabetic foot ulcers found that a significantly higher proportion of Grafix-treated patients achieved complete healing at 12 weeks (62 percent) in comparison to 21 percent in the standard wound care group.1 The study authors also noted that the Grafix-treated group had lower percentages of adverse events (44 percent versus 66 percent) and wound-related infections (18 percent versus 36.2 percent) than the control group.
Kazu Suzuki, DPM, CWS, notes that Grafix uses the proprietary manufacturing process BioSmart to preserve the inherent properties and structural matrix of fresh placental membrane. Dr. Suzuki says the unique cryopreservation process produces an unaltered extracellular matrix that he calls rich in native collagen, growth factors and resident cells such as fibroblasts, epithelial cells and mesenchymal stem cells. The company says Grafix protects tissue from infection, reduces inflammation and lowers the incidence of scarring. Dr. Suzuki has used Grafix grafts at his facility since last fall.
“We are very impressed with the wound healing results we have seen in our own patients and we now use (Grafix) almost daily in our wound care center,” he says.
Osiris notes that Grafix eliminates the potential pain and complications that may come with harvesting autologous grafts. In his clinical experience, Dr. Suzuki says acellular, dehydrated, irradiated or devitalized skin substitutes may be not as efficacious in wound healing as Grafix. Unlike other grafts on the market, Grafix offers the benefit of endogenous cell viability as a result of its cryopreserved functionality, notes Dr. Suzuki. He adds that Grafix’s three-dimensional architecture of the collagen rich matrix provides a scaffold to facilitate wound closure through a sustained release of growth factors.
“In practice, Grafix grafts have been quite useful in closing difficult wounds, including complex wounds with tendon and bone exposure,” says Dr. Suzuki, the Medical Director of the Tower Wound Care Center at the Cedars-Sinai Medical Towers in Los Angeles. “We believe it is one of the most effective skin substitute grafts on the market today, possibly even more effective than the patients’ own split-thickness skin grafts.”
Dr. Suzuki notes that due to the proprietary manufacturing and cryopreservation process, Grafix requires a freezer for storage as well as thawing prior to product application. He says the product’s price is on par with other amniotic membrane grafts and it is reimbursable with the use of appropriate Q-codes.
PluroGel Burn and Wound Dressing (PluroGen). An inventive biomaterial is an integral part of a new wound dressing.
PluroGel Burn and Wound Dressing is based on surfactant technology in high viscosity material and provides an optimally moist wound healing environment, according to Stephanie Wu, DPM, MSc, FACFAS, the Associate Dean of Research and a Professor of Surgery at the Dr. William M. Scholl College of Podiatric Medicine at Rosalind Franklin University.
The manufacturer PluroGen notes that PluroGel, which is not antimicrobial, is for patients with chronic wounds and burns. The company says the dressing’s PluroGel Biomaterial’s surfactant quality is cell-friendly and biocompatible. PluroGel has shown superior performance and cost-effectiveness in comparison to standard of care treatments, according to the company.
Dr. Wu has used PluroGel for about six months and calls it “a great addition to a wound care physician’s tool kit.” She says patients spread the paste in a 2-3 mm thick layer on a wound to help remove debris and can change it as required. Since the paste is made out of a surfactant that thickens at body temperature, this allows better retention on the wound site, according to Dr. Wu.
Dr. Wu cautions that patients need to apply PluroGel daily, which may be difficult for some patients.
The FastCast OLS includes a low-level compression sock for edema management and a padded sock for comfort, according to the manufacturer Hollister Wound Care. For infection management, the cast features Hollister Wound Care’s antibacterial Hydrofera Blue Ready Foam and Endoform dermal template, which the company says provides an extracellular matrix and can reduce matrix metalloproteinases.
The FastCast is the first total contact cast designed so patients can apply it while sitting rather than rolling onto their stomachs, according to Greg Bohn, MD, a Fellow of the American College of Surgeons.
He notes the cast is sturdy and ventilates well. In addition, if patients get the FastCast wet, it will dry quickly, notes Dr. Bohn, who is affiliated with the West Shore Medical Center in Manistee, Mich. He says moisture can be a problem in other casts due to the potential for maceration and infection.
Dr. Bohn, who has used the cast for about a year since it was in its prototype stage, notes there can be an initial learning curve with the FastCast. To make application quicker, he makes a template of each patient’s foot, which he can reuse.
Relieving Lower Extremity Pain
Quell (NeuroMetrix). For patients with lower extremity pain, relief does not necessarily require medication. Quell is a device patients can wear on the leg that uses OptiTherapy to calibrate an optimal stimulation level to provide maximum pain relief and help patients get a good night’s sleep, according to the manufacturer NeuroMetrix.
Dr. Wu says patients can use the non-invasive Quell either alone or in conjunction with medication therapies, and it does not require a prescription. She notes Quell offers customizable pain relief that one can track via an iOS app, helping users understand what changes in sleep activity and levels of therapy are most optimal for them. Dr. Wu says this information could also be useful for healthcare providers if patients are comfortable providing it to them.
Dr. Wu says it is the only FDA-cleared device of its kind approved for use while a person is sleeping. The device is reportedly able to detect when a user is sleeping and automatically decreases therapeutic intensity to help prevent stimulation from disrupting sleep. Dr. Wu says the device is lightweight and has a discreet form to allow users to take their pain therapy with them wherever they go.
“The Quell device provides true functionality and actionable insights to those suffering from chronic pain disorders, including diabetic peripheral neuropathy, sciatica, fibromyalgia and osteoarthritis, among others,” says Dr. Wu.
Although Quell is new to the market, Dr. Wu has seen the results from the device’s predecessor Sensus. She says Quell improves on the Sensus technology, allowing patients to track their therapy and progress on their mobile devices.
“The data captured regarding therapy, activity and sleep will be helpful for healthcare providers to track patient progress,” notes Dr. Wu.
Quell utilizes similar technology to the traditional transcutaneous electrical nerve stimulation (TENS) devices but as Dr. Wu points out, other TENS devices are typically not wearable, meaning that patients could only use them while at home or in a doctor’s office. She asserts that Quell is twice as powerful as currently available TENS devices and utilizes innovative nerve stimulation technology that calibrates automatically for every user, determining the ideal therapeutic intensity of electrical nerve stimulation to provide optimal pain relief. Unlike other TENS devices, Dr. Wu says Quell provides stochastic (random) stimulation to limit therapeutic plateaus in the nerves.
Dr. Wu adds that people with existing implanted devices that utilize electrical stimulation — such as a pacemaker, defibrillator or implanted TENS device — should not use Quell.
What You Should Know About A New Scar Gel
Celacyn Prescription Scar Management Gel (IntraDerm). Unsightly scars from surgery and previous medical treatments can be embarrassing for patients. A new gel can help cover the appearance of scars.
Celacyn Prescription Scar Management Gel is the first 510K cleared prescription scar management gel, according to Tracey Vlahovic, DPM, an Associate Professor and J. Stanley and Pearl Landau Fellow at the Temple University School of Podiatric Medicine. She notes that patients can use Celacyn to minimize scarring post-procedure and after healing.
As the manufacturer IntraDerm notes, Celacyn is intended for the management of old and new keloid and hypertrophic scars from trauma, surgical procedures and burns. The company adds that patients would apply the gel to skin three times a day for a recommended eight weeks of treatment.
Dr. Vlahovic, who has used the product since last January, says Celacyn is affordable for both insured and non-insured patients. She adds that there is a coupon program that limits what a cash paying patient would pay (under $40) and Dr. Vlahovic says this makes it accessible to a range of patients. Celacyn is fragrance free and relieves the itch and pain associated with scars, according to Dr. Vlahovic, IntraDerm says the gel is non-irritating and non-cytotoxic.
1. Lavery LA, Fulmer J, Shebetka KA, et al. The efficacy and safety of Grafix for the treatment of chronic diabetic foot ulcers; results of a multi-centre, controlled, randomized, blinded, clinical trial. Int Wound J. 2014;11(5):554-60.