Reinventing The Delivery Of Quality Care

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By Jeff Hall, Editor-in-Chief

There are some consistent themes that have emerged from this year’s roundup of leading innovations in podiatry. “Minimally invasive” seems to be the phrasing of choice as the technology seems to be more and more focused on reducing patient pain and downtime via more targeted surgical solutions. In addition to products geared toward common podiatric ailments such as flatfoot, plantar fasciitis and Achilles tendonitis, there are other modalities in the mix that may not be on the cusp of mainstream acceptance, but show intriguing promise for the future. Without further delay, here is what the experts had to say … 1. Minimally Invasive Injectable Graft (Wright Medical). As Harold Schoenhaus, DPM, and colleagues wrote earlier this year (see page 22, May 2003 issue), Minimally Invasive Injectable Graft (MIIG) offers “surgical grade calcium sulfate that has been formulated to replace defects in metaphyseal bone and provide temporary structure for hardware fixation in fractures.” Steven Boc, DPM, Chairman of the Department of Foot and Ankle Surgery and Director of Residency Training at St. Agnes Medical Center in Philadelphia, praises the osteoconductive biomaterial of the MIIG. In his experience, Dr. Boc has found that the MIIG provides a stable, osteoconductive scaffold that hardens within three minutes. He says the MIIG is an “excellent way to fill large osseous defects secondary to limb deformity as well as those formed from bone tumors.” Dr. Boc recalls one particular case of a patient who came into the office with a 2 cm tibial metaphyseal defect from a previous arthrodesis failure. He says they removed the failed bone block, put in MIIG and achieved arthrodesis and stability for the patient within four weeks. Dr. Schoenhaus, the Chief of Foot and Ankle Surgery at the Graduate Hospital in Philadelphia, has used the MIIG as an intraoperative option for patients who undergo implant arthroplasty of the first metatarsophalangeal (MPJ) joint, but lack the adequate bone stock to keep the implant in place. As he and his colleagues noted in the article, they found that patients who underwent the procedure with MIIG had “adequate dorsiflexory motion of the great toe and (were) able to stand on their toes.” They also noted that post-op radiographs three months out revealed that there was no “bulldozing or loss of stability of the implant” and the implant position had remained unchanged. “MIIG is an excellent alternative approach to implant seating in light of poor proximal phalangeal support,” wrote Dr. Schoenhaus, a Fellow of the American College of Foot And Ankle Surgeons. Exploring Minimally Invasive Treatment Options 2. Isoguard System (Koby Surgical). This five-component system offers podiatrists minimally invasive surgical approaches to performing Morton’s neuroma decompressions and plantar fasciotomies. When it comes to the intermetatarsal nerve decompression, the Isoguard system is indicated when the patient has failed conservative treatment for chronic neuroma pain or when the surgeon opts to decompress the nerve as opposed to excising it. Bruce Werber, DPM, concurs, noting that he reserves the small incision procedure for patients who have relatively new neuromas of less than a year in duration and have failed sclerosing alcohol injections and orthotic control. While Dr. Werber cautions that he has only performed eight procedures with this device to date and that eight months out is a better barometer to judge the effectiveness of the procedure for Morton’s neuroma, he says the preliminary results have been “very encouraging” so far. Dr. Werber, the President of the American College of Foot and Ankle Surgeons, reports no recurrences and that all of the patients have done well postoperatively with minimal inconvenience to their lives. He notes that those who had sedentary jobs went back to work the next day. He says one nurse took some time off but was back at work in two weeks and was “extremely happy” with the results. ‘A Bridge To Epithelialization’ 3. GammaGraft (Promethean LifeSciences). GammaGraft is a human skin allograft that may be used as a temporary dressing for burns, chronic wounds and partial and full-thickness wounds, among other indications, according to the manufacturer Promethean LifeSciences. David G. Armstrong, DPM, says GammaGraft “works well on the diabetic foot and perhaps even better on venous leg ulcers.” “We have been using GammaGraft for over two years and have found it to be a very promising bridge to promoting epithelialization after a wound has filled in to a superficial state,” notes Dr. Armstrong, the Director of Research and Education within the Department of Surgery, Podiatry Section, within the Southern Arizona Veterans Affairs Medical Center in Tuscon, Ariz. The company notes that GammaGraft acts as a vapor barrier “that limits fluid and protein loss from the wound while preventing infection.” Since the modality offers epidermal and dermal layers, the company says GammaGraft may be a more durable and effective vapor barrier than some artificial skin substitutes, which lack the keratinocyte layer. Another key differentiating factor is the ability to store GammaGraft at room temperature for up to two years. It is readily available to use when you open the package as opposed to other dressings that require more preparation time before you use them. “We use GammaGraft as a wound cover and apply it until it stimulates the wound bed to produce an aggressive granular response or adheres and desiccates,” adds Dr. Armstrong. “We generally will change the dressing every five to seven days.” When using GammaGraft on some partial thickness wounds, the company notes the modality will remain on the wound for four to six weeks. This is especially the case if these patients are nutritionally depleted or immunosuppressed. The manufacturer says the modality will remain on full-thickness wounds anywhere between two to six weeks depending upon local wound conditions. Getting Sustained Antimicrobial Activity 4. Aquacel Ag (ConvaTec). Aquacel Ag is a silver-impregnated dressing that may be used to treat burns, pressure ulcers, surgical wounds and diabetic foot ulcers, according to the manufacturer. In last month’s article, “Achieving Adjunctive Success With Wound Dressings,” Alan J. Cantor, DPM, noted that “wound exudate activates the (dressing’s) delivery of silver in a sustained manner.” (See pg. 50, July 2003 issue.) “When we have used this dressing, it has facilitated superb management of exudate, reduced pain at dressing changes and enhanced wound bed appearance with decreased slough and non-viable tissue,” wrote Dr. Cantor, a Fellow of the American College of Foot and Ankle Orthopedics and Medicine. ConvaTec also points out that the antimicrobial dressing kills a broad spectrum of wound pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE). Dr. Cantor adds that he uses Aquacel Ag on “wounds of various etiologies” and has also used it on donor graft sites. What’s The Verdict On Ultrasonic Debridement? 5. Sonoca 180 (Soring, Inc.). There does seem to be a growing buzz about ultrasonic assisted wound treatment (UAW) as a potential alternative to surgical debridement. Whereas surgical wound debridement can be quite painful when the patient has a chronic, necrotic wound and there is always the risk of removing intact granulation tissue, using the Sonoca 180 low-frequency ultrasound device may provide more targeted and gentler debridement, according to Soring, Inc., the manufacturer of the device. The company notes that the device’s ultrasound pulse enables the accompanying wound treatment solution to have deeper tissue penetration. It also notes that the device’s probe tip shaft allows for direct application to a specific problem area and facilitates a gentle flushing of fibrin deposits and bacteria growth. “We look at ultrasonic wound debridement much in the way we look at maggot debridement therapy (MDT). This device helps to debride wounds in a more precise and safer fashion than standard steel surgical debridement,” explains Dr. Armstrong, a member of the National Board of Directors of the American Diabetes Association. “In fact, what we see is that ultrasound works similar to MDT, (but) potentially faster.” Dr. Armstrong says ultrasonic wound debridement “works well on large wounds with a high degree of fibrotic tissue/slough.” However, he does caution that the device is expensive, which may prohibit more widespread usage. “Whether this product can fit into the armamentarium of most clinicians remains to be seen,” notes Dr. Armstrong. Re-Emerging Surgical Tools And Emerging Procedures 6. Osteotomy guides (Vilex). Richard Braver, DPM, has been using a Vilex osteotomy guide during Scarf bunionectomy procedures for the past year and a half and has found it to be fairly effective. Dr. Braver, a Fellow of the American College of Foot and Ankle Surgeons, says the guide “improves the accuracy of the bone cut.” He adds that the guide also compensates for sliding of the bone that may occur during the osteotomy and “takes pressure away from the second metatarsal.” In his article, “Mastering The Scarf Bunionectomy,” Lowell Scott Weil Jr., DPM, urged readers always to use an osteotomy guide when performing the Scarf osteotomy (see pg. 40, January 2003 issue). “The proper direction of this guide pin is essential since it will formulate the displacement of the metatarsal head-shaft fragment,” wrote Dr. Weil, a Fellow of the American College of Foot and Ankle Surgeons. “If you direct the pin laterally and plantarly, there will be lateral and plantar displacement of the metatarsal. If you direct it slightly proximal, it will cause a small shortening of the metatarsal as well. In the great majority of cases, plantar displacement of 2 to 3 mm is desirable to offset any elevatus of the first metatarsal and decrease the load under the second metatarsal.” 7. Mosaic plasty osteo-cartilage transfer. Patrick DeHeer, DPM, says the keys to this procedure (which is primarily performed to address talar dome lesions) are correct orientation and placement of the medial malleolar osteotomy and proper orientation of the osteochondral graft placement on the talus. The procedure is more advantageous than other procedures for osteochondral lesions in that it allows you to replace hyaline cartilage with hyaline cartilage, as opposed to fibrocartilage, points out Dr. DeHeer, a Fellow of the American College of Foot And Ankle Surgeons and a Diplomate of the American Board of Podiatric Surgery. He says the procedure does require a harvest site, which is usually the knee, so you would need to collaborate with an orthopedic surgeon, who can harvest the graft. Dr. DeHeer also says the procedure should be reserved for compliant patients as it does require six to eight weeks of strict nonweightbearing postoperatively. Dr. DeHeer adds that this procedure may also turn out to be an exciting potential treatment for other conditions, such as hallux limitus cases with degenerative joint disease. A Closer Look At A Promising Ex Fix Device 8. Sheffield Ring Fixator (Orthofix). While there are different options for external fixation devices, Dr. Armstrong says the radiolucent parts, flexibility and easier assembly make the Sheffield Ring Fixator a potentially “promising” modality. "Since one does not have to adhere to the standard Ilizarov concept of multiple rings on either side of a defect with this device, you do not have the amount of hardware to assemble pre- and intraoperatively,” points out Dr. Armstrong, who emphasizes that it is “much easier” to assemble than other ring devices. As with all external fixation devices, Dr. Armstrong says there is a learning curve to the modality and concedes that much of the learning curve occurs postoperatively. “While these patients may begin weightbearing as early (in our opinion) as one to two weeks, personal pin care and close follow-up are central tenets to quality management,” explains Dr. Armstrong. However, Dr. Armstrong notes that one of the key strengths of the device is that all of its parts are radiolucent, which makes it easier to assess post-op results. He also emphasizes that the Sheffield device is “much more flexible” than the standard Ilizarov set and is easier to adjust postoperatively. Dr. Armstrong says he and his colleagues have primarily used the device in reconstruction of the unstable Charcot neuroarthropathic foot and have also used the mini-rails for distraction of the first MTPJ. Orthofix adds that the device may also be employed for other indications including post-traumatic, acquired and congenital deformities; limb lengthening and arthrodesis of the ankle and subtalar joints. Dr. Armstrong also cautions that it is an expensive modality that is currently in the neighborhood of $5,000. “Adding a bone stimulator to the mix may double the price,” he notes. Other Options For Achilles Tendonitis And Flatfoot 9. AirHeel (Aircast). Designed to treat Achilles tendonitis and plantar fasciitis, this pneumatic compression dressing (formerly known as the Pneumatic Achilles Wrap) has undergone a couple of modifications that may further enhance patient comfort and compliance. Dr. Braver says the aircell in the back of the device is a key strength as it provides additional support and compression for the Achilles, which helps reduce swelling. A team physician for college and professional football teams, Dr. Braver also notes that the AirHeel features a tricot mesh material as opposed to using vinyl material. He says this material change provides “more supportive and fuller arch support.” When you add in the device’s neoprene sleeve, Dr. Braver says the AirHeel is a “very comfortable device that is easy to use” and it should have a “favorable impact on patient compliance.” 10. Kalix implant (New Deal/Wright Medical). While there is a learning curve with the device, Dr. Braver says the device’s uniportal procedure, mechanism and results make this implant a good option for flatfoot correction. According to Dr. Braver, it is a minimally invasive procedure that requires one small incision over the lateral aspect of the sinus tarsi joint. He says the implant “blocks the head of the talus from plantarflexing … and reduces subtalar pronation.” The manufacturer of the implant says its conical shape and controlled expansion help restore talus and calcaneal alignment, which facilitates a recreation of the foot arch. Dr. Braver concurs. While he cautions that he has only performed six procedures with the Kalix implant so far, Dr. Braver says he has consistently seen a “higher arch and less patient pain.” While the implant is primarily used for flatfoot correction in children and adults, the manufacturer of the device says it is also indicated for tarsal coalitions, subtalar instability and supple deformity in patients who have posterior tibial tendon dysfunction.

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