When you’re the new kid in town, it can be hard to adjust. But sometimes, if you hit the ground running, you can find yourself at the center of everyone’s attention. In the field of extremities repair, the reverse shoulder replacement procedure is still relatively new, but the number of performed procedures is growing at such a pace that it has exceeded both the surgeons’ and the device manufacturers’ expectations.
Though in use in Europe for about 15 to 20 years, the reverse shoulder replacement procedure was only approved by the FDA for use in the U.S. in March 2004. Since then, this new kid in town has made a dramatic impact on the shoulder repair market. From 2004 through 2008, total shoulder replacements, including reverse and partial replacements, have grown by almost 60% in the United States according to the PearlDiver Patient Record Database, United States healthcare reports and information from other databases. The market for reverse shoulder replacements, which had barely 2, 000 patients in 2004, has grown to an estimated 15, 000+ patients in the past five years.
The billing code for reverse shoulder replacements and total shoulder replacements may still be the same, but these procedures have one key difference. A normal total shoulder replacement prosthesis device includes a simple ball, called the “humeral head, ” and a socket joint called the “glenoid.” A reverse shoulder device has a metal ball that replaces the glenoid and a plastic socket that replaces the humeral head, changing the mechanics of the total shoulder device and, in effect, reversing it. The reverse shoulder replacement device has been especially useful for older patients with fracture-related injuries, rotator cuff injuries and arthritis.
The reverse system products and treatments are now getting more worldwide recognition than primary shoulder replacement devices due to improved performance that provides much-needed relief for an ageing population. The PearlDiver database reveals that almost 47% of the patients who received a total shoulder replacement through 2004 to 2007 had either partial or full rotator cuff tears, one of the common symptoms experienced by patients who received a reverse shoulder replacement. These patients have experienced fewer complications, and the reverse shoulder replacement procedure appears to provide the best care for patients who have rotator-cuff-tears as well as arthritis in their shoulders.
While physicians use the total shoulder replacement procedure to treat severe shoulder arthritis and to help patients regain their mobility and experience relief from pain, reverse shoulder replacements provide relief to patients who suffer from the triple threat of chronic pain, arthritis and rotator cuff tears. This procedure can provide patients improved function and pain relief by replacing the worn out joint surfaces with an artificial joint made of metal and plastic.
The shoulder is the third most commonly replaced joint in the United States. While the numbers for shoulder replacements are not anywhere near those for hip and knee joint replacements, the growth in this segment, especially since the advent of reverse shoulder replacement procedures, has been no less than phenomenal. Reverse shoulder procedure provides a far more sophisticated option for patients with complicated shoulder joint injuries. Chart 1 shows the 2008 procedure volume for shoulder joint replacement patients (including reverse, total, and partial) compared to other segments of the joint replacement market.
Chart 1: Joint Replacement in Orthopedics for 2008
Source:PearlDiver Patient Record Database research and estimates. The volume includes all replacement including total, partial, and revision.
Chart 2: Procedural Forecast for Shoulder Replacement Market in U.S. (2004-2012E)
Source: PearlDiver Patient Record Database, Orthopedic Network News and other press releases.
The fact that the billing code is the same for both the total shoulder and the reverse shoulder replacement procedures can result in a diagnostic mix-up. Diagnoses commonly associated with the total shoulder replacement procedure are arthritis and osteoarthritis, while rotator cuff sprain and the complete rupture of the rotator cuff with severe arthritis condition are among the most common diagnoses associated with the reverse shoulder replacement procedure. Chart 3 illustrates the most common diagnoses related to the shoulder replacement billing code (ICD-9-P-81.80, CPT – 23472) derived from the PearlDiver database.
Chart 3: Common Associated Diagnoses
Source: PearlDiver Patient Record Database 2004-2007
The shoulder repair market represents almost three–fourths of the total extremities market, due mainly to the enormous progress made by orthopedic companies in developing the total shoulder, partial shoulder, and the new reverse shoulder replacement products. The shoulder repair market is now close to being a $500 million market worldwide and is growing at 15% or more annually.
DePuy, Inc. and Tornier, Inc. are the current industry leaders, and these two giants share half of the global shoulder repair market. Zimmer Holdings, Inc., Biomet, Inc., Encore Medical Inc. (Reable Therapeutics), and Exactech Inc. are other key players within this market.
Biomet Comprehensive Reverse Shoulder SystemThe rapid success of shoulder repair devices is not only due to better clinical outcomes and performance but also the continuous improvement of products and technology, such as reverse shoulder systems. The leading reverse shoulder products and their manufacturers are Delta Xtend from DePuy, Aequalis from Tornier, Anatomical Reverse System from Zimmer, and the Equinoxe System from Exactech.
A key product on the market today is the second generation reverse shoulder system from Biomet introduced in May 2009. Called the Comprehensive Reverse Shoulder System, the device provides more intraoperative flexibility and has fewer limitations than did the first generation device.
Dr. Dave Adkison of Birmingham, Alabama, a specialist in sports medicine and surgery of the knee and shoulder and a Board Certified Fellowship-Trained Orthopedic Surgeon, has professional experience using the Reverse Shoulder System from Biomet. Dr. Adkison told OTW in a recent interview that he sees this technology as a vehicle to treat the most difficult shoulder problems, especially those that involve rotator cuff arthropathy and those shoulder operations which require revision. He believes Biomet’s new product has a superior fixation on the glenoid plate and glenosphere and best restores the center of rotation of the shoulder. He finds that the second generation product has much better stability and improved prevention of scapular notching. Furthermore, the modular options and offsets allow the shoulder to be ideally placed to fit the patient’s anatomy. Dr. Adkison also mentioned that early motion restoration has been exceptional.
Another group to watch is a small company in Gainesville, Florida, called Exactech. Though its sales figures are relatively small, the company’s innovation and strong product portfolio have brought it success with its total shoulder and reverse shoulder systems. In 2005, Exactech’s shoulder device sales were less than $3 million, but the company is now aiming for $25 million in shoulder device sales for the fiscal year 2009.
Reimbursement for a reverse shoulder replacement is similar to that for a total shoulder replacement which is remarkable considering the more advanced technology involved and better patient outcomes that a reverse shoulder replacement provides. According to PearlDiver research based on Medicare data, the average reimbursement for the facility is $9, 835 and the average physician reimbursement is $1, 280.
Even though shoulder repair represents a minuscule portion of an estimated $31 billion global orthopedic market, recent revenue growth has made shoulder repair a well-defined market that is targeting high growth driven by continuously improving technology. The result is a variety of innovative products that are providing improved outcomes for patients with very sore shoulders.
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