How many surgeons/hospital staff does it take to treat a supracondylar fracture? More than one would expect (about 2-4), because the current procedure for correcting the fracture is subject to variation depending on the training method of the treating surgeon, difficulty of the fracture, and the surgeon’s estimate of accuracy of alignment (example video of current procedure). With roughly 65,000 children between the ages of 3 and 12 needing treatment for supracondylar fractures each year in the US alone, hospitals and patients may be subjected to a multitude of burdensome costs due to revision procedures and additional hospital staff time. Last Monday, a small start-up called Fixes 4 Kids, based out of Salt Lake City, UT, announced the launch of its first product, the E-Fix and E-Thotic system (“E” being short for “Elbow”), at the AAOS (American Academy of Orthopedic Surgeons) annual meeting. The system is expected to greatly improve patient outcomes by setting the fracture more accurately during the initial procedure, thereby reducing the likelihood of complications such as Cubitus Varus (gunstock elbow), a condition caused by malunion of the broken fragments.
Although busy preparing for the launch last week, President and CEO Kurt Vedder and Director of Marketing Joel Melton, shared their enthusiasm about the company, the new product, and expected impact on the current procedure through an interview with Medgadget.
Janelle Chang, Medgadget: Why did Fixes 4 Kids decide to focus on supracondylar fracture over other types of fractures?
Kurt Vedder: We wanted to work on such fractures because the current procedure, which is not standardized, requires [physicians] to pull on the limbs or open the child and put in, for example, IM (intramedullary) rods. There was a desire to develop technology that would replace manual therapy (such as pulling on limbs) and decrease the chance of having to open up the arm/limb as that can create a different set of risks. We felt this product could make an impact on reducing a lot of complications and provide a standard procedure to surgeons that range from orthopedists to pediatric specialists.
Others fractures such as in the forearm and wrist have higher incidences, but in children supracondylar fracture is a very high profile fracture that provokes anxiety in orthopedic surgeons because of the unpredictability around the degree of difficulty of the fracture. It is highly innervated and vascularized, and if not done correctly can lead to deformity or nerve damage for example.
Medgadget: Why did you focus on fractures over other orthopedic concerns?
Kurt Vedder: We were focused on supporting a smaller company to bring a product to market quickly that could have a profound impact. Regulatory requirements drove our ultimate decision not to pursue other options such as an implant because it could mean a very long product development cycle and the time to market and time to making an impact would be reduced.
Medgadget: How does the E-Fix and E-Thotic work?
Kurt Vedder: While the child is asleep, the E-Thotic is put on the forearm and upper arm to stabilize the fracture. Then the E-Fix is attached to the operating table utilizing any standard OR table rail. The two systems attach and work with an alignment system to dial in the fracture. It moves in 6 planes of motion (3 translations and 3 rotations) to be able to line up the fracture accurately. This procedure is routinely performed with fluoroscopy since it is a closed procedure and the surgeon can see the fracture on the X-ray imaging. During the next part of the procedure, which involves pinning the aligned fracture in place, the E-Fix/E-Thotic system provides the physician with the advantage of keeping his hands free while placing the pins, compared to the manual method in which one hand is supporting the patient’s arm during the procedure. Once pinned, a side brace and elbow cuff are attached between the orthotic on the forearm and upper arm. This assembly (made from an injected molded polymer with padded interior) replaces traditional casting.
Medgadget: Does the patient wear the E-Thotic for less time than a regular cast?
Kurt Vedder: No, they wear it for the same amount of time but it is more comfortable based on feedback from leading pediatric orthopedic surgeons. Some of the features that make it so comfortable are that the E-Thotic orthosis is completely adjustable due to the integrated Boa Closure System and is lined with foam on the inside so that it is more comfortable against the patient’s arm. In the standard procedure, a full arm cast is typically placed on and will loosen as the swelling reduces so the patient needs to come in to the clinic and have the cast removed and a new cast placed. With the E-Fix/E-Thotic system, it is just a minor adjustment [of the dial on the orthotic to fine tune the fitting].
Medgadget: How was the fitting of the orthotic determined?
Kurt Vedder: The orthotic is considered a custom fit. It adjusts to diameter and length of each patient. We provide it in two sizes (small and large) and right and left for both of those sizes. As we were designing the orthosis, we placed the prototype orthosis on hundreds of kids to arrive the right fit. The data we collected on arm sizes and length was calculated and compared against anthropometric data available on the public domain.
Medgadget: Are there any plans to pursue the adult market with this design?
Kurt Vedder: I would believe there is a huge opportunity in the adult market for other fractures like forearm and wrist, which is being considered [but isn’t the current priority for our company].
Medgadget: How do the two procedures compare financially? Are they considered as equivalent for reimbursement?
Kurt Vedder and Joel Melton: We chose an area in the body that has good reimbursement. The orthotic is fully reimbursable and the procedure itself has existing CPT codes. The E-Fix gets paid for over time with the number of times it is used. Overall there is less financial burden for the hospitals and patients because of less OR time required, less fluoroscope time, better outcomes, and less staff needed to complete the procedure. We believe a single physician can do this by himself versus needing 2-4 additional people to help him. Better outcomes will minimize second operations and osteotomies thus saving money long term (staff and physician time, office visits, etc.). Additionally, this technology allows the child to be treated on site at the local community hospital instead of the common practice of sending the child to the pediatric hospital, which can incur high cost if for example the patient needs to be air evac to the hospital. Other benefits are peri-operative since re-casting (if required) and additional office visits (sometimes up to 6) may not be reimbursable.
Medgadget: Where is the product currently approved?
Kurt Vedder: The system is registered in the US with expected CE mark at end of June 2013. No clinical data is required since it is not an implant, but a small post-market study will be completed to allow a feedback channel between surgeons and the development team.
Medgadget: How is the product being positioned in the market?
Joel Melton: The E-Fix is similar to capital equipment as it can be re-used while the E-Thotic is a disposable one time patient use product. Surgeons who have used the E-Fix see multiple uses with this technology so it could support multiple procedures outside of supracondylar fractures in the future.
Medgadget: Are there plans for future iterations of this product?
Kurt Vedder: The company will be working on ease of use type functions and lowering the profile of the system. We would like to get to the forearm and wrist and are conceptualizing next gen for development by second half of this year and reduce to practice by first half of next year. For these procedures, our surgeon advisors are very excited by the opportunity to prevent having to open the arm – eliminate surgery, cosmetic scaring, and reduce overall procedure time.
The E-Fix/E-Thotic System is manufactured by Fixes 4 Kids through ComDel Innovation (Whapeton, North Dakota) and distributed worldwide through Mizuho OSI, a Leading Orthopedic Surgical Device Manufacturer and Distributor.