By Carolyn Rogers
The pilot phase of the American Joint Replacement Registry (AJRR)—the culmination of three years of intensive planning by the AAOS—is now under way.
The 18-month pilot project, which will involve 10 hospitals and approximately 1,250 patients, was launched in January 2004. Actual data collection is scheduled to begin in April and will continue for 12 months. By June 2005, the success of this “trial run” will be evaluated, at which time the AAOS Board decide whether to continue the pilot as a national launch.
Goals of a national registry
The ultimate goal of the AJRR is to assist surgeons in medical and surgical decision-making and, thereby, to reduce the morbidity and mortality associated with total joint replacements (TJR) and to improve patients' care and outcomes. Specific goals include:
“A national registry is an important patient safety tool for many reasons,” says William J. Maloney, MD, chair of the Joint Registry Pilot Project Team. “By tracking and identifying poorly performing implant devices, the registry will effectively serve as a post-market surveillance tool—a system which currently is not in place in the United States.”
Implementation of this system is “critical,” Dr. Maloney says. “There are literally hundreds of implant systems that are approved for use in this country, and new technologies are being introduced all the time. In the words of a colleague, ‘We are performing a vast human experiment and not keeping track of the results.'”
TJR revision surgeries common
Although TJR surgery is widely recognized as one of the most valuable and cost-effective interventions in medicine today, premature failures of orthopaedic devices can and do occur. Revision surgeries account for 17 percent of hip replacement surgeries performed each year in the United States, and 8 percent of knee replacement surgeries.
Revision rates appear to remain constant over time, but the number of arthroplasties is expected to increase dramatically in coming years due to wider acceptance of joint replacement, growth of the senior population and the incidence of arthritis. Despite these alarming statistics and factors, however, there is currently no comprehensive, national system in place in the United States to track, monitor, and disseminate information about hip and knee implant utilization and the long-term outcomes of joint replacements.
National Joint Registry workshop
In December 2001, the Academy held a two-day workshop, in cooperation with the Agency for Healthcare Research and Quality (AHRQ), to explore the feasibility of developing a nationwide joint registry in the United States.
Representatives of medicine, industry and government—including AHRQ, the Centers for Medicare and Medicaid Services (CMS), the National Institutes of Health and the Food and Drug Administration (FDA)—gathered in Washington, D.C., for the workshop, along with representatives from other national registries, such as Sweden and Canada.
Recommendations from the workshop included the exploration of a pilot project for collecting registry data and the establishment of subsequent planning groups.
Development of the pilot project
The Academy took action on these recommendations by establishing a Joint Registry Oversight Panel and two work groups—the Pilot Project Team and the Governance Team. The AJRR project was assigned to the Council on Research and Scientific Affairs, which is chaired by Joshua J. Jacobs, MD.
Since mid-2002, the Oversight Panel—chaired by David G. Lewallen, MD—has been responsible for overseeing the efforts of the two work groups, maintaining communication between them on relevant issues and reporting to the Board of Directors. Other members of the Panel include Drs. Maloney and Jacobs, Richard D. Coutts, MD; Norman Johanson, MD; William W. Tipton, Jr., MD, and members of AAOS staff.
Dr. Coutts chaired the Governance Team, which examined questions of policy, procedures, leadership, structure, access, data management, legislation and legal issues associated with running a nationwide registry. The Pilot Project Team, chaired by Dr. Maloney, was charged with developing a research project to demonstrate that registry data is collectable. The AAOS Board of Directors approved a business plan for the pilot phase of the project in June 2003.
Partnership with SunClinical
The Academy is partnering with an outside vendor, SunClinical Data Institute, because previously considered proposals (e.g., use of Medicare data) were unable to capture laterality and device information, which are vital to the success of a registry. SunClinical is a software company with ties to more than 1,800 hospitals nationwide that gathers, analyzes and reports data.
AAOS entered into an agreement with SunClinical in November 2003 for development of an electronic data collection tool as well as data collection, transfer and warehousing services. The company will be responsible for identifying confidential patient and physician information and for providing a series of reports back to the AAOS.
In exchange for the Academy's project oversight and facilitation of introductions to targeted hospitals, administrators and leading orthopaedic surgeons at those hospitals, SunClinical has agreed to develop the software and hardware infrastructure that will capture all data points necessary for Level I data, including data on laterality and implant type.
The pilot project will involve ten hospitals, with three to four on-site surgeon contacts at each hospital. Each participating orthopaedic surgeon will enroll approximately 25 patients, all of whom must sign consent forms. Each hospital will be required to gain Institutional Review Board approval for the project.
The Level I data to be collected will include:
To gauge the progress of the systems and procedures, SunClinical will issue reports at three, six and nine months after initiation of the pilot. A final report and a “mock implant recall” will be created as well, based on parameters specified by the Academy. The mock recall ensures that, in a time of crisis, patients with a particular implant can be identified.
Benefits to AAOS, members
The AJRR and the pilot project will provide multiple benefits for the AAOS and its members, including:
This last benefit is key, according to Dr. Maloney. “When there is a problem with an implant, the registry will allow us to identify those patients who have the specific implant,” he says. “This has been an ongoing problem in the United States when implants are recalled. It is actually very difficult to find all the patients who have been subjected to a poorly performing system.”
The AJRR also will allow hospital systems to determine how they are performing relative to hospitals of similar size and volume, he says. “The simple process of providing feedback and benchmarking one's self against one's peers has a positive effect on outcome.”
The Academy recently established a governance structure for AJRR, consisting of an Oversight Board and two committees-a Hospital Recruitment Committee and a Data Validation Committee. The Oversight Board will help with the design and oversight of the pilot and subsequent AJRR, and the Hospital Recruitment Committee will supervise the recruitment of institutions and orthopaedic surgeons for the pilot and AJRR. The Data Validation Committee will be charged with assessing the validity and reliability of the data collection and analysis for the pilot and AJRR.
The new Oversight Board will be chaired by Dr. Lewallen and Daniel J. Berry, MD, will serve as vice-chair and representative of the American Association of Hip and Knee Surgeons. The Hospital Recruitment Committee will be chaired by Dr. Maloney and Dr. Coutts will lead the Data Validation Committee. Dr. Jacobs; James N. Weinstein, DO; and Khaled J. Saleh, MD, will serve as members-at large.
In addition, Paul M. Gertman, MD, of SunClinical, will be a nonvoting member of the Board; Jack E. Parr, PhD, will serve as the industry representative, and Robert B. Bourne, MD, will serve as a consultant.
Future of the AJRR
The AAOS will seek federal and not-for-profit foundation support for the registry project and for studies using AJRR data, Dr. Lewallen said. “If the Pilot Project is deemed successful, the AJRR will help develop a long-term funding mechanism to provide ongoing support for a comprehensive national registry for collection of data on all arthroplasty patients.”