Emerging advances in podiatry include a new system to facilitate plantar plate repair, new diagnostic tools, a topical wound care gel and the development of amniotic membrane for use in podiatric surgery. Accordingly, this author talks to various experts to get their insights on these new innovations.
In the latest roundup of innovations in podiatry, emerging modalities range from a new plating system for the Lapidus procedure and a non-pharmaceutical topical for dystrophic nails to an intriguing bone graft modality and an advanced diagnostic tool for detecting peripheral arterial disease. Without further ado, here is what the experts have to say on ten of the most innovative products for podiatric physicians.
1. Anchorage (Stryker). An innovative surgical solution can help surgeons achieve enhanced compression in internal fixation while maintaining stability.
The Anchorage system (Stryker) is very procedure specific and designed for Lapidus and first metatarsophalangeal joint (MPJ) fusions, according to Lowell Weil Jr., DPM. He says the compression ramp technology permits interfragmentary compression incorporated in plates. The Anchorage creates “an unusual amount of stability with compression” for internal fixation, which Dr. Weil notes somewhat mimics the properties of external fixation.
Stryker notes that the compression ramp technology creates mechanical compression between two corresponding bone segments. The company adds that the Anchorage has dedicated plates for each indication to boost anatomical congruence and the product’s cannulated instrumentation can increase efficiency in the operating room.
Dr. Weil, the President of the Weil Foot and Ankle Institute in Chicago, says there are “some rumors” that there will be greater plating options for the Anchorage system in the near future.
2. Contours Lapidus Plating System (Orthofix). Another option for Lapidus procedures is the Contours Lapidus Plating System (Orthofix). The company notes the placement of the locking screw captures the “sweet” spots of bone to permit optimal purchase and the screw configuration is trapezoidal to facilitate the stability of the fusion. Orthofix adds that the system’s stable construction can resist significant loads.
Raymond Smith, DPM, has been using the Contours Lapidus Plating System since its release a few months ago. He cites its innovative design, anatomical configuration, easy application, compression and reproducibility. Orthofix notes that the Contours system is designed specifically for the tarsometatarsal anatomy and Dr. Smith concurs, citing the plating system’s anatomical fit to the first tarsometatarsal joint as a key advantage.
“The offset nature of the plate fits perfectly to the tarsometatarsal abutment and the medial face of the medial cuneiform, resulting in greater stability,” explains Dr. Smith, a Fellow of the American College of Foot and Ankle Surgeons who is in private practice in Edmond, Ok.
3. Complete Plantar Plate Repair System (Arthrex). The plantar plate can be a challenge for surgeons to repair but a new plate repair system can facilitate easier anatomical access. The Complete Plantar Plate Repair System allows plantar plate repair through a dorsal incision, according to the manufacturer Arthrex.
“This is a hugely innovative technology,” says Dr. Weil. “The development of the procedure and the instrumentation will allow a very common foot problem to finally be repaired anatomically.”
Arthrex notes that the system comes with Micro SutureLassos and a Mini Scorpion DX, which provide suture passing options in the plantar plate. The system’s Mini Joint Distractor can facilitate surgeon visualization and access to the confined space of the plantar plate, according to Arthrex.
As Dr. Weil notes, the development of plantar plate pathology is nearly always mechanically based and previous plantar plate repairs inadequately address the totality of the problem. The Complete Plantar Plate Repair System is the first opportunity to address all aspects of the problem, according to Dr. Weil. This technology derives from arthroscopic shoulder surgery and he says it has been adapted and refined for the specific needs of the forefoot.
Dr. Weil has been using the product’s general plate repair technology for almost six years. He says the system simplifies the plantar plate repair and makes the procedure reproducible for all foot and ankle surgeons. In addition, Dr. Weil says one can use the Arthrex system to appreciate pathology in its entirety from a dorsal perspective.
4. PedCAT (CurveBeam). Although surgeons consider weightbearing X-rays as the standard of care to evaluate non-traumatic foot injuries, Kent Feldman, DPM, notes that the two-dimensional nature of X-rays can often prevent one from making a true assessment of foot structure and alignment. He says the pedCAT (CurveBeam) solves this problem as it is the first three-dimensional weightbearing advanced foot and ankle imaging modality. Dr. Feldman has used the imaging device for eight months.
Curvebeam notes that the pedCAT, which recently received FDA approval, uses computed tomography (CT) and can provide scans in under seven minutes. Dr. Feldman adds that single foot scan time is approximately 25 seconds, the two foot scan time is under one minute and computer processing time is under four minutes. As he says, the pedCAT allows one to evaluate the three-dimensional nature of the foot and ankle in a weightbearing position. Dr. Feldman says this capability assists in evaluating subluxations and dislocations, such as Lisfranc’s dislocations, and is helpful in the preoperative evaluation of flat feet.
“The pedCAT is advantageous over traditional X-rays, which have inherent spatial flaws due to bony superimposition and radiographic distortions due to variable magnification (bones closest to the film are more anatomically correct and those farther from the film are magnified) and distortions due to beam angle,” says Dr. Feldman, a Diplomate of the American Board of Podiatric Surgery, who is in private practice in San Diego.
Dr. Feldman emphasizes that the pedCAT uses 5 to 10 percent of the radiation of a traditional CT scanner, exposing the patient to less cumulative radiation. However, he still urges caution in using any radiation-emitting device on patients. Dr. Feldman will only use the pedCAT on patients with a pathology that he cannot evaluate effectively with plain radiographs. He also uses the modality for weightbearing preoperative planning and to evaluate pathologies that have been historically evaluated via CT.
5. Sensilase PAD-IQ (Vasamed). Skin perfusion pressure (SPP) can be a valuable and efficient indicator of the presence of peripheral arterial disease (PAD). The new and improved iteration of one device for measuring SPP is more portable with advanced analysis techniques.
The latest generation of the laser-based SPP monitor, the Sensilase PAD-IQ (Vasamed), is “drastically smaller and lighter” at about 15 pounds, notes Kazu Suzuki, DPM, CWS. He notes that physicians can now carry it from room to room or secure it to an intravenous pole.
Dr. Suzuki says the PAD-IQ has two channels — in comparison to one channel for the previous Sensilase model — that allow one to test both limbs at the same time and reduce the testing time by half. He notes the interface is entirely based on a touch screen so physicians can operate the device without a mouse or keyboard.
“I have had this new PAD-IQ device for a few weeks and I am quite impressed with its form factor (smaller and lighter),” says Dr. Suzuki, the Medical Director of the Tower Wound Care Center at the Cedars-Sinai Medical Towers. “The simple fact that I can measure two areas at one time also cuts down on the testing time, especially when I am measuring multiple limb levels on complicated vascular patients.”
Another facet of the PAD-IQ is its “Studycast” cloud computing feature, which enables physicians to send the test results wirelessly to the Vasamed’s Studycast secure Web site, according to Dr. Suzuki. He says that feature allows one to review and interpret the test results, and share them with colleagues for better communication among medical disciplines and building referral bases.
Dr. Suzuki used the original Sensilase device for seven years and calls it an “absolute necessity for our wound care practice” for monitoring SPP to assess the wound healing potential by measuring the skin capillary blood flow. He says measuring SPP is vital for wound care and surgery planning as well as for diagnosing peripheral arterial disease. Dr. Suzuki emphasizes that skin perfusion pressure is a more accurate and reproducible microcirculatory test in comparison to transcutaneous oximetry monitoring. He also notes that SPP offers a big advantage over the ankle-brachial test as it is not affected by calcified arteries that often occur in patients with diabetes or those on dialysis.
Dr. Suzuki notes that since the laser Doppler monitor is proprietary, one will need to purchase or lease the unit. However, he notes that since non-invasive vascular tests are fully reimbursable tests with appropriate diagnosis and medical necessity, one should be able to recoup the cost relatively easily. For example, Dr. Suzuki says the PAD-IQ allows one to perform and submit for CPT code 93923 (non-invasive physiologic study of lower-extremity, three levels or measurements with reactive hyperemia). He says this CPT code is listed as 0.45 Work RVU and has a $183.51 facility rate in his Los Angeles area.
6. Excellagen (Cardium Therapeutics). A new topical gel may help foster improved healing in chronic wounds. Excellagen is a fibrillar bovine Type I collagen-based topical gel (2.6%) that could provide adjunctive debridement benefits in non-healing diabetic foot ulcers, according to the product’s manufacturer Cardium Therapeutics.
Arthur Tallis, DPM, says the product’s full-length collagen molecules are in their natural, fibrillar form, and are formulated in a unique physiologic buffer that ensures maintenance of the collagen molecule’s structure and function. Dr. Tallis, a Fellow of the American College of Foot and Ankle Surgeons and the American Professional Wound Care Association, was involved in Phase 1 and Phase 2b diabetic ulcer trials for Cardium Therapeutics.
Dr. Tallis has applied Excellagen following surgical debridement in the presence of blood cells and platelets. He notes that Excellagen activates human platelets, triggering the release of platelet-derived growth factors (PDGF).
Dr. Tallis also notes that Excellagen can save time for the physician and patient as dressing changes are required only once a week. He notes additional advantages of Excellagen are that no thawing or mixing of components is required prior to use. Dr. Tallis adds that one can easily apply the formulation to wounds of all sizes and shapes, and the product achieves complete, even wound coverage without dripping. He says 0.5 cc of the collagen can treat a wound up to 5 cm2 in area.
As Excellagen contains bovine collagen, Dr. Tallis cautions that it is contraindicated in patients who have a known sensitivity to products of bovine origin. Excellagen requires refrigerated storage and he says one must allow some time for the product to achieve room temperature before applying in order for the product flowability to be at its best. The shelf life is 18 months.
7. Naftin 2% cream (Merz Pharmaceuticals). An improved formulation of a topical antifungal may be beneficial for patients with tinea pedis.
Patients used the older Naftin 1% (naftifine) formulation twice a day for four weeks. Tracey Vlahovic, DPM, says patients can now use the 2% Naftin once daily for two weeks. She cites the advantage of a shorter treatment time, noting that it will likely facilitate more adherence in patients.
Manufacturer Merz Pharmaceuticals notes that Naftin 2% is indicated for interdigital tinea pedis, tinea cruris and tinea corporis caused by Trichophyton rubrum.
Dr. Vlahovic, an Associate Professor and J. Stanley and Pearl Landau Fellow at the Temple University School of Podiatric Medicine in Philadelphia, was involved in the product’s clinical trials and has used it for patients since the recent launch of the product.
8. Augmatrix (Biomimetics Therapeutics). A new orthobiologic technology may be a useful tool for filling bone voids in the lower extremity.
Augmatrix is approved for use in combination with autogenous bone marrow, notes Peter Blume, DPM, FACFAS. He says the product is composed of synthetic carbonated apatite and bovine type I collagen in a 55:45 ratio (w/w). The manufacturer Biomimetics Therapeutics notes the carbonated apatite component closely resembles the mineral phase of bone and Augmatrix granules provide an enhanced osteoconductive scaffold that supports bone remodeling. The carbonated apatite disperses throughout the collagen matrix and the entire construct is 80 percent porous, which Dr. Blume says allows for absorption of bone marrow aspirate and stem cell attachment.
“Augmatrix is an exceptional osteoconductive graft with osteogenic potential (provided by autogenous stem cells) and an innovative option for bone repair,” says Dr. Blume, an Assistant Clinical Professor of Surgery, Anesthesia and Orthopedics and Rehabilitation at the Yale School of Medicine. “As an off-the-shelf product, Augmatrix represents a cost-effective alternative to autograft that spares patients additional pain and morbidity from a bone graft harvest site.”
Dr. Blume says Augmatrix does not carry an allogeneic risk. He also points out that the product has improved handling characteristics in comparison to commercial allografts and provides an added benefit from live autogenous stem cells when mixed with bone marrow aspirate. Dr. Blume says Augmatrix contains a higher percentage of collagen at 45 percent in comparison to similar synthetic products that contain an average of 20 percent or less. The higher collagen content provides for efficient absorption of bone marrow aspirate, adds Dr. Blume.
9. Neox (Amniox Medical). Amniotic membrane has had proven success in eye surgery for years as an anti-inflammatory and anti-adhesive barrier. Christopher Hyer, DPM, has been using the Neox human amniotic membranes for about a year in foot and ankle cases, and has seen good results.
The manufacturer Amniox Medical says Neox uses the Cryotek process, which can deliver the membranes to surgeons in a hydrated form, preserving its natural elasticity and saving time in the OR. The company adds that one can cut Neox to size and suture it in place.
Dr. Hyer, a Fellow of the American College of Foot and Ankle Surgeons, notes there are “no other products out there” to reduce and prevent scarring or adhesions in a postoperative setting. He says artificial products like silicone sheathes are not effective and elicit foreign body reactions. In contrast, he says the anti-scarring properties of amniotic tissue are very useful around tendons and nerves.
10. Nuvail (Innocutis). Dystrophic nails can be an issue for patients with onychomycosis but a new non-pharmaceutical modality may provide a solution.
Nuvail (Innocutis) is a topical nail polymer that does not have a pharmaceutical agent and is indicated for dystrophic nails, according to Dr. Vlahovic. She says one can use it in conjunction with other onychomycosis therapies such as laser treatments and orals, or psoriatic nail therapies.
Dr. Vlahovic cites a clinical trial showing that 60 percent of patients had improvement in their nail appearance at six months just with using Nuvail.1 She notes that Nuvail recently received the approval of the Food and Drug Administration.
Dr. Vlahovic adds that Nuvail is advantageous in that it forms a waterproof barrier so patients do not have to reapply the topical each time they get their nails wet.
1. Nasir A, Goldstein B, van Cleeff M, Swick L. Clinical evaluation of safety and efficacy of a new topical treatment for onychomycosis. J Drugs Dermatol. 2011; 10(10):1186-91.