Industry News

National Joint Replacement Registry Passes its First Test

There is data now on more than 1,000 patients—a drop in the bucket, really, compared with the more than half a million hip and knee replacement procedures performed annually in the United States—but it nonetheless is enough to deem the first test of the American Joint Replacement Registry (AJRR) a successful one.

The registry kicked off its pilot data collection project late last fall, gathering information from 16 organizations ranging from academic centers and small community hospitals to private orthopedic practices. Architects of the registry chose the participants (from an original pool of 75) based on the diversity of their geographic location, size and practice type.

Staff members involved in collecting statistics at each of the participating healthcare institutions were trained on a Web-based data entry software system before the pilot project began. The participants collected basic information (dubbed “Level 1 data” by AJRR executives) from patients, including name, date of birth, social security number, diagnosis (ICD-9 code) and gender. Surgeons and hospitals submitted their names and addresses as well as key information about the procedure: the ICD-9 code, the date of surgery, the type of procedure (hip or knee), laterality (right and/or left), and implant data (manufacturer and catalog number). All the information—except for laterality—already is submitted to the Centers for Medicare & Medicaid Services for billing, according to the project’s organizers.

Eventually, AJRR staff hope to collect information about co-morbidity and higher levels of outcome data, but additional funding and infrastructure will be needed before such statistics can be assembled. The American Academy of Orthopaedic Surgeons (AAOS) estimates that 193,000 total hip replacements and approximately 581,000 total knee replacements are performed in the United States annually.

AJRR leaders conducted the pilot data collection project to better understand the difficulties of gathering information about joint replacement procedures and to identify the reporting methods that best work for hospitals before the registry is launched on a large-scale basis.
One of the main challenges for participants, registry organizers discovered, was ensuring that all the data were collected and entered accurately in a timely manner, and that the task itself did not become an added burden for healthcare employees.

Other issues were identified during the pilot project as well. One surgeon noted the importance of educating patients about the registry, particularly in hospitals that require consent before gathering personal data about those seeking treatment. And while the AJRR obtained commercial Institutional Review Board (IRB) approval as well as a HIPAA (Health Insurance Portability and Accountability Act of 1996) waiver of authorization and waiver of informed consent needed to conduct the data collection pilot, some hospitals, such as the NYU Hospital for Joint Diseases in New York, N.Y., needed approval from its local IRB as well to participate in the program.

Identifying the challenges that confronted healthcare organizations during the pilot project will help the AJRR clarify the methods needed to assemble data. It also will enable the registry’s organizers develop a process for recruiting and training additional hospitals and receiving and storing the information they collect.

“Some hospitals already have data systems and registries in place,” Randolph R. Meinzer, AJRR’s director of information technology, told AAOS Now, a monthly journal published by AAOS. “We need to know what to incorporate into the application to enable the AJRR to acquire their data.”

The registry’s staff will evaluate commercially available and custom software data collection applications before deciding on the kind of computer program and technology that will be used for the national registry. The AJRR’s board of directors is hoping to have a production system in place by summer so the registry officially can be launched later this year.

Though it currently is working to recruit an additional 160 hospitals to participate in the registry, AJRR leaders have set a more ambitious long-term goal for themselves: achieving 90 percent participation over the next five years of the estimated 5,000 U.S. hospitals where arthroplasty procedures are performed. In order to do that, however, the AJRR is going to need solid funding and some convincing arguments for hospitals to participate. Grants from payers and the government can help finance the registry, but it won’t be enough to keep it running, leaders warned. As aresult, board members are toying with the idea of charging subscription fees to those seeking detailed implant and patient data. They also are discussing financing options with “industry colleagues.”

“We’re receiving grant support from various orthopedic organizations and there may be opportunities for individual orthopedic surgeons to contribute through the Orthopaedic Research and Education Foundation,” David G. Lewallen, M.D., AJRR board chairman, said during an informational session about the registry during the AAOS annual meeting in mid-February. “We’re getting a receptive ear from payers in terms of the issue of incentivized reporting.”

Much of the registry’s success is going to depend on its collaboration with the organizations that support joint replacement procedures such as AAOS, The Hip Society, The Knee Society, and the AmericanAssociation of Hip and Knee Surgeons. Each of these groups have provided

financial support to the registry and are represented on its board.

“We will face ongoing challenges as we try to finalize the financial end,” Lewallen told AAOS Now. “We’re really starting a small business and we want to do that carefully.”

Surface Dynamics Opens Two Manufacturing Plants

Talk about double duty. Surface Dynamics recently opened two coating manufacturing facilities, one in Memphis, Tenn., and another in Cincinnati, Ohio.

Both plants provide the same services, applying biomedical coatings and thermal spray coating solutions to products used in orthopedic, dental and spinal implants. The company uses porous plasma-sprayed CP-titanium coatings, hydroxyapatite coatings and plasma-sprayed coatings of titanium or hydroxyapatite on PEEK (polyetheretherketone).

The Cincinnati facility is 9,000 square feet and the Memphis site is 14,000 square feet, according to the company. Both locations have the same quality systems and manufacturing capabilities, including laser and e-beam sintering for rapid manufacturing and metallurgical laboratory.

“We strategically placed our plants in Memphis and Cincinnati to accommodate our customers, who design, engineer and manufacture medical implants,” Memphis Managing Director Roy Smith said in a news release.

The company also plans to open an overseas facility to better serve its global customers. Surface Dynamics already partners with Italian biomedical coating company Eurocoatings, a move that has become a key component to the firm’s product and service offerings, founder Leo Glass said.

“Our goal in joining with Eurocoatings is to improve or raise the bar on coating value while continually improving quality,” he explained. “With Eurocoatings’ HA (hydroxyapatite) coating and our titanium coating technology, we will improve the overall outcome for the device manufacturer as well as theultimate customer, the patient.”

New SpineGuard Product Takes Surgeons Around the Bend

SpineGuard Inc. is throwing surgeonsa curveball.

The privately held French firm has introduced a new pedicle screw placement device based on its signature PediGuard product. Dubbed PediGuard Curv, the device features a curve-tipped probe rather than a straight tip. The product officially debuted at the American
Association ofNeurological Surgeons annual meeting in Denver, Colo., in early April.

The new device is expected to enable SpineGuard to further penetrate the spinal surgery market. Company executives estimate that about 30 percent of surgeons prefer to use a curve-tipped probe when placing pedicle screws into the spinal column. According to surgeon feedback about the product, those estimates seem to be accurate: The company has received encouraging feedback over the last four months as it introduced the PediGuard Curv to select geographic markets. The device has been used in 30 spine surgeries since mid-December, according to the company.

“The PediGuard Curv improves my ability to navigate the most difficult pedicles, especially in patients with spinal deformity,” said Sigurd Berven, M.D., associate professor in residence, director of Spine Fellowship and Resident Education in the Department of Orthopaedic Surgery at the University of California, San Francisco. “The curved tip allows for redirection and precise control of direction in three plans. The overall effect is a significant improvement in safety.”

And safety is at the heart of the PediGuard system. The handheld device, which received U.S. Food and Drug Administration approval in 2005, enables surgeons to accurately place pedicle screws during spinal procedures. PediGuard prevents pedicle screw misplacements by analyzing the electrical conductivity of surrounding tissues in real time through audio and visual signals. The device detects changes in tissue type and alerts surgeons to the change during preparation of the screw site.

The market for pedicle screw-basedstabilization devices has been growing inrecent years due to the prevalence of spine instabilities and deformities as well as theincreasing number of surgeons being trained in pedicle screw-based technologies.

The criticality of pedicle screw placement has been highlighted by published reports showing that high rates ofmisplacements can lead to such serious complications as quadriplegia.

The criticality of pedicle screw placement is one of the main factors that SpineGuard executives believe will drive sales of the company’s new product. “We are very encouraged by the initial feedback on PediGuard Curv,” Pierre Jérôme, SpineGuard CEO, said in a news release. “This new product is strongly expected to be adopted quickly, especially in the U.S., where a large group of spine surgeons have learned to place pedicle screws via a curved-tip instrument.”

SpineGuard was founded in 2009 by Jérôme and Stephane Bette, former executives of Medtronic Sofamor-Danek. The company, which has its U.S. headquarters in San Francisco, Calif., received $15million in venture capital funding through July 2009 from four private equity andinvestment firms.

AAOS Welcomes New Board Members During Annual Meeting

The American Academy of Orthopaedic Surgeons (AAOS) has a new slate of leaders.

During its annual meeting in mid-February in San Diego, Calif., members chose Daniel J. Berry, M.D., and John R. Tongue, M.D., to serve as president and first vice president, respectively, and Joshua J. Jacobs, M.D., of Chicago, Ill., to serve as second vice president of the organization. The trio will serve one-year terms.

Active in the AAOS since 1998, Berry has served on numerous committees and task forces, including the American Joint Replacement Registry and the CME Courses Committee. He most recently served as vice president and second vice president of the Academy. He also held the position of president of the AmericanAssociation of Hip and Knee Surgeons (AAHKS) and held previous leadership roles for the American Board ofOrthopaedic Surgery, the Hip Society and the Mid America Orthopaedic Association.

He currently serves as professor oforthopaedics, College of Medicine at Mayo Clinic and chair in the Department of Orthopaedic Surgery at Mayo Clinic.

A graduate of Northwestern University in Evanston, Ill., and the St. Louis University School of Medicine in Missouri, Tongue served as an intern and general surgery resident at the University of Oregon Medical School in Portland, Ore. He then completed his orthopedic surgery residency at the San Francisco Orthopaedic Residency Training Program. He completed a sports medicine fellowship at the Orthopaedic Fracture Clinic in Eugene, Ore., and a hand surgery fellowship at the University of California in San Francisco. Currently, Tongue maintains his private practice in Tualatin, Ore., and also is a clinical associate professor at Oregon Health Sciences University in Portland.

Jacobs is an adult reconstructive orthopedic surgeon with an expertise in total joint replacement and a research interest in the biocompatibility of orthopedic biomaterials. He currently serves as the William A. Hark, M.D./Susanne G. Swift professor and chairman of the Department of Orthopaedic Surgery at Rush University Medical Center in Chicago. He is a partner and member of the Executive Committee of Midwest Orthopaedics at Rush (a private practice) and he also is an adjunct professor in the Materials Science and Engineering Department in the McCormick Technological Institute of Northwestern University in Evanston, Ill.

For six years, Jacobs chaired the Council on Research, Quality Assessment and Technology. He is the past president of the Orthopaedic Research Society and is the current president of the United States Bone and Joint Decade. He also serves as a trustee of the Orthopaedic Research and Education Foundation and is past chair of Committee F04 on Medical and Surgical Materials and Devices of the American Society for Testing and Materials International. Jacobs recently completed a four-year term on the National Institute of Arthritis and Musculoskeletal and Skin Diseases Advisory Council and has chaired multiple National Institute of Health study sections.

In addition to electing a new president and first vice president, AAOS members added three of their colleagues to the group’s board: Naomi Shields, M.D., a foot an ankle surgeon in Wichita, Kan.; Mininder Kocher, M.D., an associate professor of orthopaedic surgery at Harvard Medical School in Boston, Mass.; and Andrew N. Pollak, M.D., trauma director and chief of orthopaedics at R. Adams Cowley Shock Trauma Center in Baltimore, Md., who will serve as the treasurer-elect. Business consultant William J. Best also assumed a seat on the board as a “lay member.”

No Bones About It: Orthovita Introduces New Bioactive Filler

Build a better mousetrap and the world will beat a path to your door. Orthovita Inc. is hoping that timeless adage holds true as it rolls out a new product that reportedly leads to faster and more abundant bone formation inside the human body.

The Malvern, Pa.-based company has launched Vitoss Bioactive Foam-2X Bone Graft Substitute (Vitoss BA2X), a non-structural bone void filler for use in the pelvis, extremities and posterolateral spine. Vitoss BA2X contains increased levels of bioactive glass and has shown through in-vitro testing to induce two times the deposition of calcium phosphate onto the surface of an implant while retaining the same handling properties.

Vitoss Bioactive Bone Graft Substitute is designed to fill bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine, which include posterolateralfusion procedures), and may be combined with saline, autogenous blood, and/or bone marrow, according to literature from the company.

“Vitoss BA2X has the same structure and porosity of Vitoss BA but contains increased levels of bioactive glass,” Orthovita President and CEO Antony Koblish said in a news release. “Our in-vitro data indicate that the increased levels of bioactive glass double the overall bioactivity of the product. Other studies have shown that increasing the bioactivity leads to faster and more abundant bone formation. We believe the combination of increased bioactivity and our scaffold design will support more effective bone formation than before.”

Vitoss Bioactive Foam-2X shares additional key characteristics with other products in the Vitoss Foam product portfolio. For example, Vitoss BA2X can hold its own volume in bone marrow aspirate while retaining these biological fluids in pliable and compression-resistant forms, thereby providing all three key components for bone regeneration: scaffold, cells, and signals.

Orthovita received 510(k) clearance from the U.S. Food and Drug Administration late last year to market Vitoss BA2X as a non-structural bone void filler for use in the spine, pelvis and extremities.

Bioactive glass currently is considered one of the most biocompatible materials in the bone regeneration field due to its bioactivity, osteoconductivity (a scaffold’s ability to support cell attachment and subsequent bone matrix deposition and formation) andosteoinductivity (a scaffold that encourages osteogenic precursor cells to differentiate into mature bone-forming cells).