Highlighting advances in foot and ankle surgery, wound care and medical technology, the author talks with thought leaders in podiatry about this year’s slate of emerging options to improve outcomes for patients.
Could new designs in surgical hardware help improve outcomes with fusions, fracture repair or total ankle replacement? Will new allografts make a difference in flatfoot intervention and fat pad reconstruction? Could advances in technology revolutionize how providers monitor patients and collect data? With these questions in mind, leaders in the field offer their insights and discuss their experience with these evolving modalities.
SpiralUp™ TCL Allograft System (Arthrosurface). Could a new allograft provide better comfort for patients with flatfoot deformities? The SpiralUp TCL Allograft System is a pre-rolled, decellularized, freeze-dried, gamma-sterilized human dermal tissue for supplementation of the talocalcaneal ligament, according to the manufacturer Arthrosurface.
Having used allograft sinus tarsi implants for six years, Jodi Schoenhaus, DPM feels the SpiralUp TCL Allograft System is a promising prepackaged implant designed to limit talar dislocation on the calcaneus and offers a viable alternative to metal implants.
“… The patient is better able to tolerate the (SpiralUp) implant and it still provides adequate control of the rearfoot,” says Dr. Schoenhaus, a Diplomate of the American Board of Foot and Ankle Surgery.
Arthrosurface adds that no rehydration is necessary when surgeons utilize the graft, which comes in seven mm, nine mm and 11 mm diameters. The system includes a delivery cannula with a trial kit to assist in proper sizing. The company shares that SpiralUp is contraindicated for those with autoimmune connective tissue disease or a sensitivity to antibiotics including polymyxin B, bacitracin, amphotericin B and gentamicin sulfate.
Do New Total Ankle Replacement Systems Facilitate Enhanced Intraoperative Flexibility?
Hintermann Series H2®/H3® Total Ankle Replacement Systems (DT MedTech). Could anatomic adaptability intraoperatively contribute to better total ankle replacement (TAR) outcomes?
The Hintermann Series H2/H3 Total Ankle Replacement Systems are fixed- and mobile-bearing total ankle implants respectively, according to the manufacturer DT Medtech. James Cottom, DPM, FACFAS shares that the complement of these two systems allows a surgeon to decide intraoperatively which is best for the patient. He shares that with both implants, there is minimal resection of the tibia (five mm with the H2 device and three mm with the H3 device). The tibial component also allows for physiological load transfer and no stress shielding, according to Dr. Cottom, who is in private practice in Sarasota, Fla.
The company relates that both systems provide optimal contact area with anatomical component design.
In addition, with the H2 or fixed-bearing implant, the way one inserts the poly into the tibial tray allows the surgeon to put the ankle joint through its full range of motion, notes Dr. Cottom, who discloses that he is a consultant for DT MedTech.
“The poly will actually rotate and move to find the isometric or correct orientation of the individual ankle. This is advantageous in that not all ankles are the same, especially after trauma, says Dr. Cottom, who implanted the first H2 and H3 implants in the United States. “This unique feature allows the implant to adjust to the individual anatomy of each patient which theoretically, will increase the longevity of the implant.”
A Closer Look At The Potential Of A New Injectable Allograft
Leneva™ Allograft Adipose Matrix (MTF Biologics). Could an emerging injectable extracellular matrix make an impact for diabetic foot ulcer (DFU) healing or fat pad reconstruction?
Leneva Allograft Adipose Matrix is an all-natural human adipose tissue, which reportedly preserves matrix proteins, growth factors and cytokines necessary for adipogenesis and angiogenesis, according to the manufacturer MTF Biologics.
Lawrence DiDomenico, DPM, FACFAS, FACPM, CWS, has used the Leneva Allograft Adipose Matrix over the last eight months for areas of increased pressure that previously resulted in DFUs. He says this internal offloading may prevent the need for soft tissue rebalancing in the right patient. Dr. DiDomenico adds that the Leneva Allograft Adipose Matrix may also be beneficial in protecting the sites of healed DFUs in patients who also suffer from fat pad loss.
“The idea is this matrix may then become a lattice for new tissue formation and prevention of DFUs,” says Dr. DiDomenico, the Director of Podiatric Residency Training at East Liverpool City Hospital in Youngstown, Ohio.
Dr. Schoenhaus has used the Leneva Allograft Adipose Matrix for over a year and notes effectiveness for DFU healing, prevention of ulceration recurrence and in providing cushioned relief in high-pressure areas of the foot. The results are promising without any current patients requiring a one-year touch up, which may be necessary with other products clinicians may employ for fat pad restoration, notes Dr. Schoenhaus, who discloses being a consultant for MTF Biologics.
The Leneva Allograft Adipose Matrix is ready to use directly from the packaging and is storable at ambient temperatures, which makes it convenient for facilities and providers, notes Dr. DiDomenico, who discloses being a consultant for MTF Biologics.
A Closer Look At New Fixation Options
AlloMate Bone Pin System (WishBone Medical). An emerging human allograft bone pin may provide surgeons an option for customizable fixation or assist in filling a void after screw removal, according to WishBone Medical.
After a year and half of experience in utilizing the AlloMate Bone Pin System, Patrick DeHeer, DPM, FACFAS, notes the impact of the modality for anatomic areas where traditional fixation poses problems.
“For example, when I am performing Gauthier-type lesser metatarsal osteotomies to correct for Freiberg’s infraction, the osteotomy is intra-articular and this can make fixation challenging,” says Dr. DeHeer, the Residency Director of the St. Vincent Hospital Podiatry Program in Indianapolis. “I use the Allomate Bone Pin through the distal aspect of the metatarsal head across the osteotomy. The bone graft heals via creeping substitution and is visible on X-ray.”
WishBone Medical says the dowel-shaped pin comes in five sizes from 2.0 mm through 4.0 mm. Dr. DeHeer cites the versatility of the system for pediatric and adult cases due to the diverse sizing and length customization.
“The AlloMate Bone Pin System provides foot and ankle surgeons an excellent option for fixation of multiple procedures,” maintains Dr. DeHeer, who discloses that is a consultant and stock owner with WishBone Medical. “The pin diameter sizes and ability to cut to length make it versatile and unique. The unique processing of the allograft preserves its strength.”
OSSIOfiber® Hammertoe Fixation System (OSSIO®). An emerging hammertoe fixation system may provide a strong, non-metallic option for securing proximal interphalangeal fusions.
Available in three sizes and two orientations (zero degrees and 10 degrees), the OSSIOfiber Hammertoe Fixation System provides an implant that fully integrates into the patient’s native anatomy without adverse inflammation, according to the manufacturer OSSIO.
Bob Baravarian, DPM, FACFAS praises the fiber-based osteointegrative material of the hammertoe implant. He notes the implant does not absorb or cause cystic changes, but incorporates into the body and forms bone as it integrates, leaving no residual material.
“Avoiding metal means the product does not need to be removed,” adds Dr. Baravarian, the Director and Fellowship Director at the University Foot and Ankle Institute in Los Angeles. “Over time (the implant) gets stronger and more ‘attached’ to the surrounding bone, which adds a solid fixation.”
This type of technology could eventually replace metal implants in multiple anatomic locations, speculates Dr. Baravarian, who discloses that is the head of the Foot and Ankle Advisory Board for OSSIO.
The company adds that the implant is visible on computed tomography (CT) and X-ray. The device is also artifact-free and safe for magnetic resonance imaging (MRI), according to OSSIO.
Stratum™ Foot Plating System (Zimmer Biomet/Nextremity). Could a novel compression apparatus make a difference in procedures such as arthrodesis and fracture fixation?
“The (Stratum Foot Plating System offers) a new approach to obtaining compression through the plate by using tines on one side of the fusion or fracture, and ramp technology on the opposite side, which allows compression prior to screw insertion,” says Troy Boffeli, DPM, FACFAS, the Program Director of the Podiatric Surgical Residency at Health Partners/Regions Hospital in St. Paul, Minn.
“The Stratum Foot Plating System is uniquely designed to allow the surgeon to achieve up to 3.5 mm of compression though the novel ramp compression design,” adds Shannon Rush, DPM, FACFAS, who is an Adjunct Professor with the California School of Podiatric Medicine at Samuel Merritt University. “This technology combined with the anatomically-designed shapes make it a very powerful system to achieve compression and stability previously unavailable to surgeons.”
The Stratum Foot Plating System includes 49 different anatomic locking plates and six screw categories, according to Zimmer Biomet. The company maintains that the hands-free tines technology resists plate shifting and that once the surgeon inserts the tines, there is no requirement for provisional K-wires to maintain the plate position. The tines have the added benefit of multiple points of fixation in small fragments, adds Dr. Boffeli, who discloses involvement in the design of the Stratum Foot Plating System and receiving royalties through Surgical Design Innovations.
Dr. Rush uses the system primarily for midfoot and medial column arthrodesis procedures. However, the unique aspects of the Stratum Foot Plating System may also be beneficial for Lapidus and great toe arthrodesis procedures in which alignment and compression are critical for success, suggests Dr. Rush, who discloses involvement in the design of the Stratum Foot Plating System and receiving royalties through Surgical Design Innovations.
Evaluating The Role Of New Technologies In Streamlining Patient Care And Data Collection
Orpyx® SI Sensory Insoles (Orpyx Medical Technologies). Could technology-enhanced shoe insoles help providers better care for patients with diabetes?
An embedded remote monitoring system is part of what makes the Orpyx SI Sensory Insoles unique in the management and prevention of DFUs, according to Orpyx Medical Technologies. The sensors monitor plantar pressure, temperature and patient movement, providing real-time alerts for the patient and data management for the provider through a cloud-based dashboard.
“In this age of telemedicine, the Orpyx insoles are ahead of the curve,” says David Yeager, DPM, FACFAS, FASPS. “They provide a positive conduit for the physician to communicate with the patient without an expensive office visit.”
After over six months of experience with the insoles, Dr. Yeager relates a positive response from patients who feel empowered to make better choices and participate actively in their podiatric care. He cites the ease of use with the ability to monitor through a cell phone. If the patient does not have a cell phone, the company provides a patient-friendly monitoring system. User error can be a downside if the patient is not capable of understanding how to use the technology, but this occurrence is very rare, says Dr. Yeager, a Past President of the Illinois Podiatric Medical Association.
Eric Lullove, DPM, CWSP, FAPWH(c) agrees that the interaction between the patient and the technology puts the management and prevention of DFUs under the direct control of the patient with increased provider awareness as well. He also cites the real-time assessments and monitoring as being key innovations with the insoles.
“To my knowledge, there is no other comparative product in the market that gives this level of data and tech back to point of care,” explains Dr. Lullove, the Chief Medical Officer of the West Boca Center for Wound Healing in Coconut Creek, Fla.
PRO-MAPP Platform (PRO-MAPP Health). Data collection and daily operations can overwhelm any practice or surgical facility. According to PRO-MAPP Health, a collaboration with surgeons, software designers and those in clinical academia led to the development of the PRO-MAPP Platform, software that may improve the collection of such data, streamline surgical practice operations, enhance revenue generation, and improve patient care and satisfaction.
The PRO-MAPP Platform is cloud-based and powerful but is intuitive and simple to use, says Dr. DeHeer, who discloses he is a consultant for PRO-MAPP Health.
“Patient-Reported Outcomes Measures (PROMs) are extremely important for long-term understanding of patient satisfaction … and is directly beneficial to improving the quality of our procedures,” maintains Dr, DeHeer. “(Collection of this data) also has a secondary benefit in justifying procedures, negotiating prices with payers, etc.”
Dr. DeHeer points out that the PRO-MAPP system eliminates many pain points for surgeons and their practices. The software system automatically generates operative reports based on the data collected and distributes billing information to the appropriate parties within seconds, according to Dr. DeHeer. He shares that he collaborated on the first podiatry application within the platform and that a suite of podiatry applications is on the horizon.
“(The PRO-MAPP Platform) really is quite painless and users actually enjoy using it without the IT drama of larger systems,” notes Dr. DeHeer.
Could Advances In Wound Care Make A Difference In Healing And Infection Treatment?
Derma-Gide® Wound Matrix (Geistlich). An acellular bilayer scaffold derived from porcine extracellular matrix, Derma-Gide may offer key benefits in facilitating wound closure.
“This novel matrix has unique tissue-filling characteristics,” notes David G. Armstrong, DPM, MD, PhD, who has used Derma-Gide for two years. “The modality’s handling characteristics are promising and we think it might be useful along with a whole host of other technologies such as negative pressure wound therapy. Time will tell.”
Citing in vitro studies, Geistlich says Derma-Gide modulates matrix metalloproteinases (MMP) activity, maintains growth factors in an active state and provides proper structure for cell migration and attachment. The company says the matrix does not require pre-hydration or rinsing prior to use. Derma-Gide conforms naturally to the anatomical defect upon application and adheres upon hydration, according to Geistlich. The company adds that the modality comes in a variety of shapes and sizes to optimize material usage.
Dr. Armstrong, the Director of the Southwestern Academic Limb Salvage Alliance (SALSA), relates that he and other researchers continue to evaluate this technology in ongoing studies.
MicroGenDX Next-Gen DNA Sequencing (MicroGen Diagnostics). Is a newer microbiology technology providing clinicians with more precise culture results? Through its MicroKEY testing options, MicroGenDX accurately identifies bacteria and fungi with next-generation DNA sequencing, according to the company MicroGen Diagnostics.
“We are moving from the era of Louis Pasteur to the era of CSI, in that our fidelity in measurement is much more robust with this type of technology,” says Dr. Armstrong, a Professor of Surgery at the Keck School of Medicine at the University of Southern Calfornia.
MicroGen Diagnostics shares that testing options can include identification of non-tuberculosis acid-fast bacilli, bacteria, fungi, yeast and mold, and includes screening for resistance genes for certain species. According to the company, MicroGenDX technology may be especially useful for organisms that fail routine identification or fail to grow on solid media.
“In time, we will know whether this additional ‘higher fidelity’ in measurement leads to more targeted therapy, more antibiotic-free days and better outcomes,” adds Dr. Armstrong.