Extremities Market is Still Maturing

Consider it a natural evolution, of sorts.
 
The planet’s extremities market, long ignored by major orthopedic device manufacturers, is finally commanding respect as companies attempt to counterbalance sluggish growth in the saturated, maturing hip and knee replacement sectors. Fueled by an aging world population, more youth-related sports injuries, and rising rates of obesity, osteoarthritis, and osteoporosis, the global extremities market is projected to be worth $15.9 billion by 2024, according to Research and Markets data. Internal fixation devices such as plates and screws have dominated the sector in recent years due to the early functionality, abbreviated hospital stays, minimal scarring, and reduced non-union risk associated with these products. Acumed LLC has particularly benefited from the high demand for internal fixation, having sold 500,000 wrist fixation implants (Acu-Loc and Acu-Loc 2) in just two years.
 
Such promise, of course, is garnering interest among major orthopedic companies that traditional have overlooked the sector in favor of the more lucrative large-joint sector. ODT’s May/June feature story “Going to Extremes” examines the trends and challenges driving the extremities market as well as some of the latest technologies available to patients. Steve Vankoski, senior director of global marketing, Extremities, for Zimmer Biomet Inc., was among the experts interviewed for the feature; his full input is provided in the following Q&A.
 
Michael Barbella: Please discuss the trends in the extremities market. What trends have you noticed this year and how do they differ (if at all) from past trends?
Steve Vankoski: One of the biggest trends in the extremities market is the increased use of reverse shoulder arthroplasty, which was approved by the U.S. Food and Drug Administration (FDA) in 2003.¹ Currently, in the United States, approximately one half of shoulder surgeries are reverse shoulder arthroplasty and the balance are total shoulder arthroplasty or hemi-arthroplasty.² In Europe, the number is higher with reverse shoulder arthroplasty accounting for approximately 70 percent of shoulder surgeries.³ Reverse shoulder surgeries are on the rise due to: increasing utilization to treat shoulder fracture patients; expanding application to patients, both elderly and more active, with impaired rotator cuff; and surgeons becoming more comfortable with the procedure and its successful outcomes.
 
We also expect to see advanced imaging with 3-D planning and patient specific instrumentation (PSI) to accelerate over the next decade. Zimmer Biomet was the first company in the market to introduce PSI for shoulder replacement. The Zimmer Biomet PSI Shoulder and Signature Shoulder solutions are 3D virtual surgery planning software, coupled with a complete set of PSI guides and a patient-specific glenoid bone model, providing a surgeon the ability to develop a personalized plan to accommodate each patient’s unique anatomy and then execute that plan with precision. The combination of the Zimmer Biomet PSI Shoulder planning software and instrument guides is designed to provide a surgeon with tools to optimize positioning and fixation outcomes and to help maximize implant performance.
 
Today, approximately 10 percent of surgeons are using PSI, and that number will continue to grow. Because shoulder surgery is complex with varying glenoid morphology of an arthritic shoulder joint, surgeons increasingly rely on advanced imaging and three dimensional planning to better understand how to place an implant. The planning is also convenient, enabling surgeons to review scans right from their own PCs or laptops.
 
Another trend is implants are becoming more nuanced. While implant base plates have historically been simply flat, recently introduced solutions come in a variety of shapes, including wedges and curvatures, giving surgeons more options to match the patient’s anatomy and preserve bone. We can anticipate these implant options to garner increased adoption in the future, particularly in combination with PSI solutions which will allow the surgeon to plan and select the optimal implant design for the patient and then place it in the ideal position in surgery. 
 
Barbella: What challenges face companies in the small joint (extremities) sector, and how are these challenges different than those faced by companies manufacturing large joints – i.e., hips and knees? How can companies in the extremities sector overcome these challenges?
Vankoski: Many surgeons operate on hips, knees, and shoulders so large orthopaedic manufacturers, such as Zimmer Biomet, have an advantage because the company owns significant market share in all those segments and can offer streamlined access to a full product line, making it more challenging for smaller companies. Nevertheless, the advantage for companies that focus on the small joint sector is they are highly specialized, and their sales force is well equipped to market specifically to shoulder specialists who are devoted to shoulder surgery.
 
Barbella: What new technologies are on the horizon? What kinds of implants hold the most potential for patients and for market growth?
Vankoski: The Zimmer Biomet Comprehensive Vault Reconstruction System (VRS), the first patient-matched glenoid implant cleared to specifically treat patients with a severely deficient rotator cuff and extensive bone loss which precludes the use of a standard glenoid baseplate, is one technology that holds the most potential for patients. The VRS uses CT imaging and advanced 3D reconstruction techniques to allow surgeons to personalize each patient’s implant. With the VRS, we can develop any shape glenoid as long as the implant falls within a certain volumetric space and utilizes a specific number of screws, ensuring the implant fits like a glove. Additionally, there is no need to remove any more bone than the patient has already lost.
 
More than 60 VRS cases have been performed since September [2016]. While the volume is not tremendously high, the technology is valuable because it offers customization, helping patients who may not have any other solution.
 
Other technologies on the horizon include stemless implants, range of motion analysis and vitamin E solutions. We have seen humeral implants become progressively shorter over the past decade and we should expect the utilization of shorter stems to contunie to increase. Some designs are so short that they have been defined as stemless. Zimmer Biomet introduced the first stemless shoulder in Europe in 2004. The clinical outcomes have been promising and we should expect clearance of multiple stemless implants in the United States in the near future. Range of motion analysis will be an enhancement of the aforementioned PSI technology that will enable surgeons to simulate on a computer the range of motion for a specific patient and shoulder implant prior to surgery so the surgeon can detect impingment, evaluate range of motion and optimize implant placement of both the glenoid and humeral implants with the goal of improved patient outcomes. vitamin E solutions, already used in hip and knee implants, are expected to enhance the durability and strength of the shoulder reconstruction. 
 
Barbella: Where does innovation come from in the extremities market? How does Zimmer Biomet stay innovative?
Vankoski: To stay innovative, Zimmer Biomet believes it’s important to focus on unmet needs, for the patient, for the surgeon and for the hospital. We believe that it is imperative to consider each of these important stakeholders when contemplating new solution strategies. Zimmer Biomet also contends that it must continue to focus on those underserved patients who may benefit from orthpaedic innovation that is simply not available to them yet. And lastly, to not pigeonhole one’s thinking and look for assets and opportunities outside of the extremities market that may serve as solutions in the extremities space. Innovation can be achieved through organic growth or acquisitions.
 
Barbella: Aside from the implants, how does the extremities market differ from large joints, or spine? What makes extremities implants a design challenge?
Vankoski: The extremities market differs from the large joints or spine markets because it is still maturing. The exact design optimization and mechanics for the shoulder market are a work in progress while the hip and knee markets are very mature. Also, patients are less aware of their options in the extremities space, specifically hand and ankle, compared to large joints.
 
Another important difference is there are two ways to reconstruct the shoulder—total shoulder and reverse shoulder arthroplasty. Reverse shoulder arthroplasty is one of the most meaningful innovations in the shoulder market in the last 15 years.
 
Other than these differences, the extremities market does not differ greatly from the large joints or spine markets. All markets engage surgeons in a similar manner, and the surgery complications, infection rates and success rates are similar across the markets.
 
Barbella: How do the technological/physiological demands of small joints differ from other orthopedic markets?
Vankoski: The technological and physiological demands of small joints differ from other orthopaedic markets in a few ways. The shoulder is the most flexible joint in the body and, generally, the loads are less than large joints.
 
The American Society for Testing and Materials (ASTM) standards for physical testing are not as established and mature for shoulder implants as they are for knee and hip implants.
 
While survivorship is similar for knee, hip and shoulder surgeries at five years, total shoulder replacement surgery may immobilize patients for a longer period because surgeons typically cut into the muscle.
 
Barbella: Where do the extremities and trauma markets overlap? How do they differ?
Vankoski: When thinking about the extremities and trauma markets, the age of the patient and the condition of the joint matter. Depending on these factors, surgeons will decide to replace or repair the joint. With a young patient, the surgeon may use trauma products to plate and repair the existing joint. With an older patient, the surgeon may use extremity arthroplasty products to completely replace the joint. Nevertheless, there is no clear age distinction on when a surgeon will opt for trauma or shoulder arthoplasty treatment as the patient’s activity level and surgeon’s personal treatment preferences are important variables.
 
Barbella: Where do you see the extremities market five years from now?
Vankoski: Five years from now we will likely see greater penetration of reverse shoulder arthroplasty, more stemless implants for total shoulder procedures, increased utilization of advanced bearing materials like vitamin E, and greater adoption and innovation in 3D personalized planning, instrumentation, and implants.

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