Predicting the Future of Shoulder Arthroplasty

Tony Finau has learned quite a lot about himself over the past 12 months. Besides gaining new insights into his fortitude, humility, and confidence, the 29-year-old professional golfer discovered a keen sense of humor he perhaps never before realized (or cared to admit).
 
The latter trait was a particular surprise to Finau’s fans, considering the clever manner in which it was divulged.
 
Shortly before the 2019 Master’s Tournament, Nike and Finau teamed up to create a signature shoe he could wear at the year’s first major should the 6-foot, 4-inch Samoan decide to partake in another disastrous hole-in-one victory run (Finau injured his left ankle during last year’s Master’s celebrating an ace at the seventh hole). Debuting on April Fool’s Day, the fairway-colored, incredibly high-topped Finau1 boot came with a three-and-a-half minute “mockumentary” that poked fun at Finau and his injury.
 
“Not a lot of people come back from that—not the injury but the embarrassment,” Carl Madore, a Nike “footwear designer,” quips in the video. Finau adds further comic relief with lines such as, “Like any elite athlete, I had to get back in the lab and rebuild my body from ground up,” and “I thought to myself, ‘What if we designed a golf shoe for stability in my ankle? Why not?’”
 
“I felt like if you can’t laugh at yourself in something like that, then I think you’re doing it all wrong,” Finau told Star Tribune (Minneapolis) sports columnist Jim Souhan at the start of the Master’s. “I thought it was quite funny after the fact, celebrating a hole-in-one and ruining my ankle for a few months.”
 
Few in Finau’s inner circle were laughing after the mishap last spring, though. Thankfully, however, Finau sustained only soft tissue damage and some torn ligaments; he rebounded the following day to shoot a four-under-par 68 in the opening round and briefly led the tournament before slipping behind three-time major winner Jordan Spieth to tie for second place with Matthew Kuchar. He finished the contest at T10, winning $286,000.
 
Although Finau now makes light of his injury, ankle sprains are no laughing matter: Studies have shown such traumas can have lasting consequences, leading to joint damage, chronic instability, and ACL troubles. Sprains have become one of the most common sports injuries and demand for non-invasive, simple solutions is expected to drive the global foot and ankle treatment market over the next half-decade. Other factors like rising osteoporosis rates and an aging world population also will contribute to the growth.
 
ODT’s May/June feature “A Little Extreme” examines the innovation being developed in this burgeoning sector (and the overall worldwide extremities market) that eventually will contribute to its solid growth over the next half-decade.
 
Baptiste Martin, CEO of shoulder replacement device provider FX Shoulder USA Inc., shared his insights on the market for the story. His full input is provided in the following Q&A.
 
Michael Barbella: What trends/factors are currently impacting the global extremities market?
Baptiste Martin: The global shoulder arthroplasty market is growing quickly with a CAGR [compound annual growth rate] estimated at 7.6 percent from 2018 to 2024 reaching $1.9 billion in 2024. The U.S. market is worth over 40 percent of the entire market. By 2021, the shoulder arthroplasty market in the U.S. will be worth $928 million, according to Business Wire. The growth in the shoulder market is primarily based on the age of the population that requires a replacement of their gleno-humeral joint for arthritis or fractures. In addition, for example, the global rate for proximal humerus fractures, a common occurrence from accidents and falls as people age, has been increasing by 15 percent a year, according to marketresearch.com.
 
Barbella: What factors are driving growth in this market? What segment is the growth most prolific—upper extremity, lower extremity, small joint (fingers, toes), etc., or is it fairly even across the board?
Martin: Patient needs will drive the development of additional new devices. Patients with allergies, specifically nickel, have become a growing patient population group. There is an increased demand for hypoallergenic implants, which could potentially improve outcomes for these patients. Likewise, as the market share grows for shoulder arthroplasty, revisions will become more frequent due to volume and the active aging population. There is a trend to follow revisions, particularly in cases involving bone loss of the glenoid, and to develop specific prosthesis to treat their patients and (potentially) improve their outcomes and post-operative range of motion—giving the same chance to everybody.
 
Barbella: What new innovations/technologies are in the works? What technologies hold the most promise for patients? For market growth?
Martin: FX Solutions was created in 2011 by Jean-Jacques Martin. In December 2017, Ekkio took over the majority ownership of FX Solutions. This, in part, began the formation of FX Shoulder USA in January 2018 to become the direct provider of FX Solutions devices in the U.S. In the U.S., FX Shoulder implanted approximately 800 prostheses in its first year (2018) and estimates that it will implant 1,700 this year.
FX Solutions introduced the first interlocking stem (Humelock II) to the U.S. market in 2016 providing surgeons an alternative to cementing humeral stem implants for shoulder arthroplasty. We, then, introduced the Humelock Reversed stem to the U.S. market in 2017. The Humelock Reversed is the only reverse stem that allows the surgeons to control the height and version with distal interlocking screws. A recent publication in JSES (Journal of Shoulder and Elbow Surgery) cited that 76 percent of non-cemented locking stems had the tuberosities heal as compared to just 54 percent with a cemented stem for proximal humerus fractures in RTSA (reverse total shoulder arthroplasty).
Also, FX Shoulder USA recently launched the first stemless reverse (Easytech Reversed) investigational device exemption (IDE) in the U.S., enrolling the first patient on Dec. 18, 2018. The stemless reverse shoulder is not yet cleared by FDA for use outside of the IDE in the U.S., but it could potentially be the future of shoulder arthroplasty. In Europe, FX Solutions has four years of follow-up on the Easytech stemless and surgeons are really receptive to this new way of doing surgery. FX has implanted 867 Easytech Reversed stemless to date (in Europe) and, as per the article in Med Device Online (April 11, 2018), stemless implants are projected to surpass stemmed implants by 2025 (in Europe). We have seen that the U.S. market has shifted to stemless for TSA and there is a real desire to further improve what is available to surgeons in the U.S.
 
Barbella: How does your company stay innovative in this increasingly crowded market? How do you differentiate yourself from other players in the sector?
Martin: As a small company, FX Shoulder has differentiated itself from the competition by maintaining its niche as a shoulder arthroplasty company only, offering a comprehensive portfolio, and prides itself on being nimble in a competitive market by reacting quickly to feedback and input. With a presence at many major and smaller regional exhibitions throughout the year, a continuous instructional lab schedule and medical education program, it has allowed us to continue evolving and looking forward to gaining a competitive advantage whenever possible. The shoulder market is continuously evolving, and we do our best to make sure that we are able to utilize our portfolio to potentially improve patient outcomes, reduce OR time for surgeons, and increase efficiency for hospital staff (size of our instruments set for sterilization cost efficiency).
 
Barbella: How is value-based healthcare and market forces like robotics, 3D printing, and computer-aided surgery impacting extremities technologies and product development?
Martin: With the development of improved computerized imaging technologies, a lot of companies have invested their resources heavily into pre-operative and intra-operative planning software in the shoulder market most recently. We are being careful and want to watch these developments to make sure that this trend is a successful tool that surgeons can use to benefit patient outcomes and to replicate successful outcomes across similar procedures.