ANNUAL REPORT Second AJRR Annual Report on Hip and Knee Arthroplasty Data

Transcription

1 ANNUAL REPORT 2014 Second AJRR Annual Report on Hip and Knee Arthroplasty Data

2 Dedication This second AJRR report is dedicated to the memory of Mark B. Coventry, MD. Dr. Coventry established the world s first and longest-running institutional joint replacement registry. The registry he established at the Mayo Clinic has demonstrated the importance of systematic collection and reporting of joint arthroplasty results. Contents ISSN (print) ISSN (online) Executive Summary About AJRR Achievements Overall Results Enrollment Submitting s Surgeon Participants Procedural Data Metrics Hip Arthroplasty Procedural Data: Hips Component Metrics: Hips Revision Data: Hips Knee Arthroplasty Procedural Data: Knees Component Metrics: Knees Revision Data: Knees Level II and III Update and Data Reporting Programming, Funding, and Alliances Programing and Funding Strategic Alliances and Affiliations Preliminary 2015 Accomplishments Appendices References

3 Foreword Along with all members of the Board of Directors and staff of the American Joint Replacement Registry (AJRR), I am pleased and proud to present this organization s second annual report. AJRR is in a period of incredibly rapid growth and progress. While there is a great deal still to be accomplished, the Registry s foundation is now established and many essential ingredients for success are progressing quickly and effectively. This report includes data collected from 2008 to 2014, but focuses on data from 2012 to The data are derived from 211,721 hip and knee replacements performed at 236 hospitals. The Registry s growth is reflected in that, as of this writing, 577 hospitals now have AJRR membership (an increase of 38% since 2014) and 336,574 hip and knee replacements have been entered into the Registry (an increase of 59% since 2014). Our ultimate goal is to include in the Registry over 90% of all joint replacements completed each year in the United States. Readers of this report will find valuable descriptive information about patterns of arthroplasty practice in the United States. There is contemporary information about total hip arthroplasty (THA) fixation, femoral head diameter, and bearing surface use. There are details about patterns of posterior stabilized and cruciate retaining total knee arthroplasty (TKA) use, and unicompartmental knee arthroplasty use. Important facts that characterize the demographics and underlying diagnoses of patients treated with hip and knee arthroplasty across the entire spectrum of the population (not just the Medicare population), are included. Several more years of data collection are needed before there is much information on implant survivorship; of course providing these data is a key goal of the Registry. This report does give some insight into patterns of early implant failure and revision burden in the United States actionable information that will grow more robust in the next several years. AJRR is building the physical, intellectual, technologic, and human infrastructure needed to collect and analyze essential data, return them in appropriate form, and provide valuable services to stakeholders. In the past year, AJRR moved into offices in the new AAOS headquarters building. AJRR has built an information technology platform that allows for rapid and reliable data collection from hospitals, and userfriendly reporting of analyzed and collated data back to hospitals. AJRR recently took over management of the California Joint Replacement Registry, a group that has great experience collecting measures of patientreported outcomes. Finally, AJRR sought and received early designation as a Qualified Clinical Data Registry (QCDR), the only registry so designated in orthopaedics and one of only 35 such registries in all of medicine. This designation, along with the acquisition of needed infrastructure, provides Registry members with a seamless method to collect Patient Quality Reporting System (PQRS) for submission to the Centers for Medicare & Medicaid Services (CMS). In addition to the large increase of the number of hospitals reporting data and the quick escalation of the number of joint arthroplasties in the database, in the next year there will be many developments that further enhance AJRR s capability. Implementation of ICD-10 will provide more robust data on laterality and the details of revision surgery. AJRR will complete a library of nearly 100,000 implants that cross references the implants generic characteristics with implant name and number. Soon, a mandated Unique Device Identifier (UDI) also will be available for all implants, which will add greater specificity and accuracy to device identification. AJRR is collaborating with other registries around the world, through the International Society of Arthroplasty Registries (ISAR), to standardize some nomenclature and device designations. AJRR has developed and will roll out platforms that permit routine collection of so-called Level II data (such as medical comorbidities) that allow for risk stratification, and Level III data (patientreported outcome measures). Finally, recently enacted legislation will allow AJRR access to CMS claims data, which will provide immediate longitudinal tracking of all arthroplasty revisions in AJRR Medicare patients, even if they have further surgery outside of hospitals that report to AJRR. This capability will immediately improve information on the performance and survivorship of implants used in the United States. I would like to thank and congratulate the dedicated AJRR staff for the past year s many accomplishments. I would also like to thank the past and current AJRR Board of Directors, my predecessor as Board Chair, William Maloney, MD, and the AJRR Medical Director, David Lewallen, MD, for all they have done to set the Registry on its current trajectory. The Registry is moving quickly to fulfill its promise as well as the needs of our patients, the orthopaedic profession, and the many stakeholders who understand the value of a high-functioning national American joint replacement registry. Daniel J. Berry, MD Chair, AJRR Board of Directors American Joint Replacement Registry 2014 Annual Report 1

4 Executive Summary The American Joint Replacement Registry (AJRR) continued rapid growth in 2014, nearly doubling enrollment from the prior year to 417 hospitals, with data collected from 236 of those hospitals. As a result of a 164% increase in numbers from the previous year, hip and knee arthroplasty procedures of all types totaled over 210,000 since inception through the end of These procedures were performed by more than 2,200 surgeons from 45 states and represented the full range of hospital types and sizes. Patients undergoing arthroplasty were more frequently female than male (56.8% of hips, 61.6% of knees), and the mean age of patients undergoing arthroplasty procedures in this U.S. sample was 67.7 years for hip arthroplasty patients and 66.1 for knee arthroplasty patients. These findings demonstrate that nearly half of these operations are performed in individuals under the age of 65 who are not likely represented in Medicare data sets. Rheumatoid arthritis has nearly vanished as an indication for hip and knee arthroplasty in the United States, accounting for less than one half of one percent of these procedures. This undoubtedly relates to the dramatic advances in medical management of rheumatoid arthritis and associated inflammatory arthropathies over the past decade. The data in this large sample of the U.S. surgical experience remain mainly descriptive pending longer term follow-up and survivorship data on implants (as affected by hospital, surgeon, technique, and patient factors) that this developing repository of data will eventually make possible. Meanwhile, meaningful descriptive data are included in this report. For example, the data demonstrate that femoral neck fracture accounts for more than one in 10 hip arthroplasties. Analysis also found that surface replacement arthroplasty, which was once widely performed, has fallen to less than 0.5% of hip procedures and were largely concentrated in just a handful of hospitals and surgeons. Knee arthroplasties were performed almost exclusively for osteoarthritis, almost always involved tricompartmental replacement, and involved the use of highly cross-linked or enhanced polyethylene in the majority of procedures. Posterior stabilized components were used in over half of all knee arthroplasties and cruciate retaining designs were used in nearly a third. Unicompartmental replacements accounted for around one out of 20 primary procedures. The revision burden, which is one measure of the success and long-term durability of these procedures, stood at 10% of all hip arthroplasties performed annually while for knees it was lower at 8.1% of all knee arthroplasties per year. These findings and other information included in this report provide a valuable snapshot of the national experience with hip and knee arthroplasty. This report also provides an information platform that will allow documentation of the high degree of effectiveness and selected problems in the performance of these procedures over the long term. AJRR relocated with AAOS and other specialty societies to Rosemont Center, a new headquarters for orthopaedics. 2 American Joint Replacement Registry 2014 Annual Report

5 About AJRR The American Joint Replacement Registry is a not-forprofit 501(c)(3) tax-exempt organization for data collection and quality-improvement initiatives for total hip and knee replacements. AJRR is a collaborative effort supported by the American Academy of Orthopaedic Surgeons (AAOS), the American Association of Hip and Knee Surgeons (AAHKS), The Hip Society, The Knee Society, hospitals, commercial health plans, medical device manufacturers, and contributions from individual orthopaedic surgeons. Mission AJRR s mission is to focus on improving care for patients who receive hip and knee replacements. By collecting and reporting data, AJRR provides actionable information to guide physicians and patient decision making to improve care. It empowers health care organizations to enhance the patient experience and benchmark performance; orthopaedic surgeons to reduce complications and revision rates; device manufacturers to strengthen post-market surveillance; and health plans to effectively manage costs. Vision AJRR seeks to become the National Registry for total joint replacement, beginning with capturing 90% of all hip and knee replacements, and to leverage this comprehensive data to enhance orthopaedic quality of care, improve patient outcomes and safety, reduce costs, and advance orthopaedic science and bioengineering. Governance and Structure AJRR is unique compared to other national registries by virtue of its multi-stakeholder support and governance. During the evolution of the U.S. arthroplasty Registry effort, a conscientious decision was made to expand from an orthopaedic surgeon-driven model to a more inclusive model involving all categories of individuals and organizations involved in the delivery of arthroplasty care. As a result, the AJRR Board of Directors is derived not only from orthopaedic surgery societies and associations, but also from organizations that represent medical device manufacturers, hospitals, health plans, and patient advocacy groups. In 2014, AJRR had a 13-member Board of Directors, which meets formally in person three times a year. The Board is responsible for AJRR s strategic direction and for oversight of its activities and operations. Initial financial support for the formation of AJRR was provided by AAOS. After formalization of the multistakeholder model, AJRR evolved to include varying levels of financial support from virtually all of the participating stakeholder groups, with the exception of the public. AJRR is evolving toward an organization largely supported by subscriptions or software licensing fees, currently paid by a subset of hospitals desiring on-demand access and display of their own data benchmarked to the national sample. The AJRR platform will soon expand to include practice groups and individual surgeons interested in similar data. Presently, AJRR is financially supported by AAOS, AAHKS, The Hip Society, The Knee Society, hospitals, and medical device manufacturers (via the Advanced Medical Technology Association AdvaMed). The 2014 industry contributors included Biomet, DePuy Synthes, Inc., DJO Surgical, Exactech, MicroPort Orthopedics, Smith & Nephew, Stryker Corporation, and Zimmer. AJRR Board of Directors In 2014, the AJRR Chair of the Board of Directors was William J. Maloney, MD, Elsbach-Richards Professor in Surgery and Chairman of the Department of Orthopaedic Surgery at Stanford University School of Medicine. Dr. Maloney represented AAOS. The Executive Committee was comprised of Dr. Maloney; Vice Chair Daniel J. Berry, MD, of Mayo Clinic; Secretary/Treasurer Steven H. Stern, MD, MBA, of United Healthcare; and Eric Rugo, MBA, of Stryker Corporation. The following were the 2014 AJRR Board of Directors: AAOS Representatives: Gregory B. Krivchenia II, MD, First Settlement Orthopaedics William J. Maloney, MD, Stanford University E. Anthony Rankin, MD, Providence Scott M. Sporer, MD, Midwest Orthopaedics at Rush and Central DuPage Orthopaedic Specialty Society Representatives: Daniel J. Berry, MD, Mayo Clinic (The Hip Society) Terence J. Gioe, MD, University of Minnesota (The Knee Society) Bryan D. Springer, MD, OrthoCarolina (AAHKS) Advanced Medical Technology Association Representatives: Pamela L. Plouhar, PhD, DePuy Synthes, Inc. Eric Rugo, MBA, Stryker Corporation America s Health Insurance Plans Representatives: Robert L. Krebbs, Anthem, Inc. Steven H. Stern, MD, MBA, United Healthcare, Inc. American Association Representative: Kristen Murtos, MBA, Skokie Public Representative: Colin Nelson, Informed Medical Decisions Foundation American Joint Replacement Registry 2014 Annual Report 3

6 At the conclusion of 2014, Drs. Maloney, Gioe, Stern, and Mr. Rugo all completed their terms of service on the AJRR Board and rotated off. Their many collective years of service are greatly appreciated. AJRR is especially grateful to Dr. Maloney whose work to initiate and then support the effort for a National Arthroplasty Registry dates back nearly 15 years. Public Advisory Board AJRR also has a Public Advisory Board (PAB). This group was established at AJRR s inception to provide direct input to the AJRR Board from both the patient and the public perspective. They have been integral to AJRR s success thus far, ensuring that there is a public voice in the Registry s governance, deliberations, data collection, reporting, and decision making. The PAB members are drawn from a wide variety of public advocacy groups and members of the public who have had joint arthroplasties themselves. In 2014, the Chair of the Public Advisory Board was Colin Nelson. Mr. Nelson is Senior Research Associate at the Informed Medical Decisions Foundation, where he oversees a portfolio of shared decision-making programs in orthopaedics and spine care. Other 2014 PAB members were as follows: John A. Canning, Jr., Chairman, Madison Dearborn Partners, LLC Sally B. Hurme, JD, Project Advisor, Education & Outreach, AARP David G. Mekemson, Patient Representative Martha Nolan, JD, Vice President, Public Policy, Society for Women s Health Research Margaret VanAmringe, MHS, Vice President for Public Policy and Government Relations, The Joint Commission Robert P. Watkins, Esq., Patient Representative Patience White, MD, MA, Co-Director, Got Transition: The Center for Health Care Transition Improvement; Professor of Medicine and Pediatrics George Washington University School of Medicine and Health Sciences AJRR Commission Established in 2014, the AJRR Commission is a group of surgeons without relevant financial conflicts who serve as independent reviewers of the data published in this AJRR Annual Report. The Commission made the final recommendation to the AJRR Board of Directors regarding the content of the Annual Report. The Commission members are known only to the AJRR Board of Directors to ensure members independence and allow them to avoid undue outside influence pertaining to the report. AJRR Committees Besides the Executive Committee, AJRR has three standing committees, each of which is described below. Full membership can be found in Appendix A. The Data Management Committee is responsible for recommendations to the Board concerning data elements to be included in AJRR and the methods by which the selected data are analyzed and reported. The committee is responsible for recommendations concerning proposed research projects. Annually, the committee submits a report to the AJRR Commission to validate the findings of the Data Management Committee. Chair: Daniel J. Berry, MD The Finance and Compensation Committee s responsibility is to review monthly statements and reports in order to keep the AJRR Board abreast of spending and incoming funding and contributions from outside stakeholders and the public. Annually, the committee makes a recommendation to the Board of Directors on staff salaries and benefits. Chair: Steven H. Stern, MD, MBA The Regulatory Committee is a group of sound professionals who monitor and respond to the influencers of the socioeconomic and legislative issues. This committee reports to the Board on governmental opportunities and obstacles affecting the development of AJRR. Co-Chairs: Kevin J. Bozic, MD, MBA and E. Anthony Rankin, MD 2014 AJRR Staff Jeffrey P. Knezovich, CAE, Executive Director David G. Lewallen, MD, Medical Director Kristine F. Baldwin, MS, Data Submission Analyst Lori Boukas, MS, Director of Marketing and Communications September R. Cahue, MPH, Senior Registry Analyst Caryn D. Etkin, PhD, MPH, Director of Analytics Steve Hamada, Senior Software Engineer Randolph R. Meinzer, Director of Information Technology Terra M. Miller, MS, Program Coordinator Matthew E. Timmers, Program Coordinator Hannelore Venable, Administrative Assistant Kate K. Witherspoon, MPA, Program Coordinator 4 American Joint Replacement Registry 2014 Annual Report

7 2014 Achievements Added 193 hospitals for a total of 417 participants for an 86% increase over 2013 enrollment covered all 50 states Over 210,000 procedures received Data as shown reflect 236 hospitals and 2,247 surgeons Designated a QCDR by CMS allowing for submission of PQRS data Demand Reporting & Electronic Dashboard System released through a subscription-based model Completed collaborative effort with Avalere Health, LLC to conduct AJRR business review Developed a Marketing and Communications Department to expand outreach efforts and strategy AJRR hired a Director and two additional Program Coordinators for a total of four full-time staff who implemented a comprehensive marketing, communication, recruiting, and retention strategy Additional personnel hired for a total of 12 staff members Conducted Level II and Level III pilot program with 20 hospitals Data collected on 8,126 procedures Hosted Worldwide Orthopaedic Arthroplasty Registries session at the AAOS Annual Meeting in New Orleans Published first AJRR Annual Report, which reflects 80,227 procedures Information Technology The AJRR Information Technology (IT) team achieved several milestones in The first was the addition of electronic reporting of procedural summary metrics via both demand reports and electronic dashboards. The Registry technology was expanded to enable collection of 11 patient-reported outcome measures (PROMs) for both quality of life and functional assessment. As a result of AJRR s continued success in recruiting participating hospitals, AJRR expanded the IT Department by hiring a Data Analyst charged with interfacing with hospital IT and clinical staff facilitating timely electronic submission of Registry data. Electronic submission via data extraction from Electronic Medical Record (EMR) systems minimizes both the manual effort of duplicating information into the AJRR technology system and errors associated with duplicative data entry. As in the past, hospitals are submitting Level I data in two ways. With the first method, hospital staff enters data manually into the system using secure web forms. The second method, electronically extracting Level I data and submitting the data directly to the AJRR data system, is used by approximately 98% of participating AJRR hospitals. The AJRR IT department has also expanded the data-reporting capabilities of the Registry technology to accept Level II and Level III data consistent with methods utilized to collect AJRR Level I data (see Appendix B). To facilitate electronic data transfers, the AJRR has established relationships and business agreements with orthopaedic charting and EMR vendors. Vendor agreements or pre-defined AJRR reports from EMR vendors relieve the burden of creating custom reports AJRR Milestones 2014 >150K QCDR At the Close of 2014, AJRR had 417 Participants Representing ALL 50 States Over 150,000 Procedures Received First Data Audit Completed Designated a Qualified Clinical Data Registry (QCDR) by CMS First Annual Report Completed That Reflects 80,227 Procedures American Joint Replacement Registry 2014 Annual Report 5

8 on AJRR s behalf. AJRR currently has agreements with eight orthopaedic charting vendors: InVivoLink, Inc.; Ortech, Inc.; URS-Oberd, Inc.; OrthoSensor, Inc.; PA & Associates Healthcare, LLC; Arthrex; MedTrak, Inc.; and Stryker Performance Solutions. These vendors submit data directly to AJRR on behalf of a participating hospital. AJRR IT staff has also been working with Epic and Cerner on predefined AJRR reporting modules. Epic released an AJRR reporting module that functions with their latest EMR and OpTime Operating Room Management System software release. Cerner released a similar reporting module in 2014 in conjunction with their SurgiNet system. AJRR technology staff continues to pursue similar partnerships with other EMR vendors with a goal of eliminating independent IT efforts for our current and future hospital participants. Patient-Specific Risk Calculator In late 2013, a Total Joint Replacement Risk Calculator developed by Ortho Apps, through a collaboration by Massachusetts General, Mayo Clinic, and University of California, San Francisco was donated to AJRR. The calculator is intended to help surgeons assess patient risk for periprosthetic joint infection within two years and 90 day mortality in relation to their comorbidities. The risk tables were generated utilizing several years of CMS data. The risk calculator is now available for surgeons to use free of charge on the AJRR website at (on the quality initiatives page). Data Completeness and Quality Monitoring The AJRR data systems verify incoming data by checking conformance to rules contained in the data system. AJRR staff continues to interact individually with hospitals to ensure that all submitting sites conform to AJRR specifications. The IT staff has been verifying the content of hospital data since inception. The submission process includes a test submission, data review, and timely feedback to participating sites in an effort to remove possible sources of error prior to submission of patient information. AJRR continues to work with all submitting sites on data content improvements in the areas of component catalog and lot numbers, formatting of International Classification of Diseases, Ninth Revision (ICD-9) codes, and other improvements to minimize errors reported to the Registry. AJRR is in the process of implementing International Classification of Diseases, Tenth Revision (ICD-10) codes into the system. It is expected the system will be fully operational once the ICD-10 transition is complete. AJRR will provide all participants with ICD-10-Procedure Coding System (PCS) guidance on which procedure codes trigger submission to the Registry, including a crosswalk from ICD-9 to ICD-10-PCS. Patient-Specific Risk Calculator on AJRR s website. 6 American Joint Replacement Registry 2014 Annual Report

9 Component Reference Database and Component Analysis In 2014, AJRR added approximately 30,000 components to the AJRR reference data system, which expanded the database to over 65,000 orthopaedic implant components. This reference set is based on components submitted over the lifetime of the Registry. Each reference component includes the manufacturer, catalog number, family name, and component type, such as femoral stem or acetabular cup. AJRR continues to work with the AdvaMed Orthopaedic Sector, the International Consortium of Orthopaedic Registries (ICOR), the ISAR, along with the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and the National Joint Registry (NJR) for England, Wales, Northern Ireland, and the Isle of Man to harmonize the component definitions, attributes, and detailed data providing a consistent framework for future component analysis requested by the AJRR stakeholders. Orthopaedic Network News continued to support AJRR by providing staff access to component information via its web-based tools. AJRR will complete database infrastructure changes in 2015 that focus on expanding the individual component attributes. Audit of Registry Data AJRR contracted with West Virginia Medical Institute (WVMI) to audit a sample of 2014 data. WVMI has a long history of collaboration with not-for-profit medical organizations, with a specific focus on validating Registry and health record data. In the spring of 2015, WVMI began an audit of N=12 (5%) hospitals that submitted 2014 data to AJRR. WVMI and AJRR undertook an effort to obtain 40 procedure files from 12 randomly selected hospitals (which reflected at least 80% power). The hospitals represented urban, rural, small, and large locations. The audit reviewed two aspects of data submission: (1) among a random sample of 40 procedures, to ensure that data submitted to AJRR correctly reflected the data in the hospital medical records; and (2) among data submitted to AJRR for a given month, to ensure that AJRR received all procedures performed at that hospital (i.e., review of cherry picking ). The audit project was completed in early August In summary, the overall audit agreement rate for the medical record review was 91.5%. This compares to and is consistent with the score of 92.3% from the audit of 2013 data. Also consistent with last year s audit, the primary errors seen in the medical records were in the variables ethnicity and race, which are optional fields. Many hospitals were unable to submit ethnicity data to WVMI as this data element is not always included in the standard medical record format. The low agreement rate in race was primarily due to hospitals not submitting this data field to AJRR because it is an optional data element, although available in the medical records. Therefore, these data elements were removed from the final score seen above. Other problematic variables included implant catalog and lot numbers and the primary ICD-9 diagnosis code. medical records often do not have a streamlined way to capture catalog and lot numbers via one system to submit to WVMI (i.e., with no lot numbers in the EMR, hospitals did not provide any lot numbers to WVMI). s submit implant data to AJRR many times via manual extraction or query of multiple systems. Multiple ICD-9 diagnosis codes may be utilized for a total joint procedure. The primary ICD-9 diagnosis codes that hospitals submitted to AJRR were appropriate for the specific total joint procedure. However, the diagnosis code submitted to AJRR was listed as a secondary (not the primary) diagnosis code in the medical records. The overall record completeness assessment rate was 85.3%, up from 77.6% last year. AJRR submitted 686 unique records and hospitals submitted a total of 804 records, meaning 118 records were not in the Registry. Sixty-six records were not in the AJRR database, while 52 records had one or more accuracy issues preventing them from matching with the Registry. There were no similarities or trends observed to suggest a reason for these records not having been submitted to AJRR. Likewise, there were no anomalous observations to suggest any cherry picking of records for nonsubmission on the part of hospitals. After examination of the files, it was determined that mismatches were generally due to differences in primary procedure code and primary diagnosis code. American Joint Replacement Registry 2014 Annual Report 7

10 Overall Results Enrollment A primary focus in 2014 was to increase the number of hospitals that participate in the Registry. Three staff members were dedicated to enroll new facilities and ensure that data were submitted in a timely fashion. As of December 31, 2014, enrollment stood at 417 hospitals, representing all 50 states (see Figures 1 and 2 and Appendix C). This was an increase of 193 hospitals over More than 25 hospitals in both California and Ohio participated while eight other states had hospitals. Figure 1: Enrollment Number of s January 2012 April July October January 2013 April July October January 2014 April July October December 2014 Figure 2: 2014 Geographic Distribution of AJRR Participating s (N=417) WASHINGTON OREGON IDAHO MONTANA WYOMING NORTH DAKOTA SOUTH DAKOTA MINNESOTA WISCONSIN MICHIGAN MAINE VT NH MASS NEW YORK CONN RHODE ISLAND CALIFORNIA NEVADA UTAH ARIZONA COLORADO NEW MEXICO NEBRASKA KANSAS OKLAHOMA IOWA PENNSYLVANIA OHIO ILLINOIS INDIANA WEST VIRGINIA MISSOURI VIRGINIA KENTUCKY NORTH CAROLINA TENNESSEE ARKANSAS SOUTH CAROLINA NEW JERSEY DELAWARE MARYLAND WASHINGTON D.C. MISSISSIPPI GEORGIA ALABAMA TEXAS LOUISIANA FLORIDA 1-5 s ALASKA s 25+ s HAWAII 8 American Joint Replacement Registry 2014 Annual Report

11 Submitting s While delays have continued from the time of hospital enrollment to actual data submission, many hospitals submit archival data from prior months or even years, which ultimately compensates in part for these delays. By the end of 2014, 236 hospitals were submitting data out of a total of 417 hospitals enrolled by that date (Figure 3). This represents nearly a threefold increase from two years before, due not only to increases in the numbers of hospitals enrolled but also to a decrease in the percentage of hospitals enrolled but not yet submitting data. Figure 3: Number of s Submitting Data by Year Number of s * Data from 2014 included one private practice data submission with 10 procedures (October December 2014) and one Ambulatory Surgery Center (ASC) with 263 procedures. As seen in Figures 4 and 5, arthroplasty procedures in the system are disproportionately performed in largeto medium-sized hospitals and teaching facilities when compared to smaller community based non-teaching facilities. Some small hospitals may not be performing elective hip and knee arthroplasty at all. Thus, the distribution of hospitals submitting data to AJRR, while spanning the full range of hospital sizes and types, is somewhat weighted toward larger sized academic and teaching facilities when compared to American Association (AHA) data on the profile of all hospitals nationally. The following figures describe the characteristics of the hospitals submitting data to AJRR. Please note some data were not available for submitting hospitals * Figure 4: Teaching Affiliation of Submitting s (N=233)* Major Teaching n=49 (21.0%) Minor Teaching n=83 (35.6%) Non-Teaching n=101 (43.3%) Source: FY2013 AHA Annual Survey Database * Not all submitting hospitals had relevant data in the AHA survey Major Teaching s: those with Council of Teaching s designation (COTH) Minor Teaching s: those approved to participate in residency and/or internship training by the Accreditation Council for Graduate Medical Education (ACGME), or American Osteopathic Association (AOA); or those with medical school affiliation reported to the American Medical Association Non-Teaching s: those without COTH, ACGME, AOA, or Medical School (AMA) affiliation Figure 5: Size (Bed Count) of Submitting s (n=246)* Small n=52 (21.1%) Medium n=118 (48.0%) Large n=76 (30.9%) Source: FY2013 AHA Annual Survey Database * Includes some hospitals that submitted in previous years but not in 2014 Small = 1-99 beds; Medium = beds; Large = 400+ beds American Joint Replacement Registry 2014 Annual Report 9

12 Surgeon Participants By the end of 2014, AJRR had collected data on arthroplasty procedures performed by more than 2,200 surgeons (Figure 6). AJRR hospitals report data for an average of 10.0 surgeons (range 1-32). These numbers include surgeons conducting only occasional hemiarthroplasty for hip fracture. Participating hospitals are expected to submit data from all surgeons performing joint arthroplasty at their facility, and tend to do so reliably based on audit data from the past two years. For 2014, the year with the most data, the average number of arthroplasties reported to the Registry for an individual surgeon was 52.3 per year. Table 1 demonstrates an average of 23.2 per year for primary hip arthroplasty (range 1-317) and 39.9 per year for primary knee arthroplasty (range 1-522). Numbers from 2014 reveal that revisions per surgeon were much lower at 6.1 per year for hip revision (range 1-76) and 5.9 per year for knee revision (range 1-103). Actual totals may be higher for some surgeons who operate at both an AJRR participating and non-participating hospital during the same year. Figure 6: Total Number of Surgeons Submitting Data by Year Number of Surgeons 2,500 2,000 1,500 1, ,477 2, Table 1: 2014 Average Procedural Volume for Participating Surgeons (N=2,247) Total Surgeons Total Procedures Per Surgeon Average Range Number of Surgeons Who Submitted Only One Procedure HIP Primary 1,822 42, Revision 757 4, KNEE Primary 1,617 64, Revision 1,045 6, Procedural Data Metrics At the close of 2014, AJRR had received data on over 225,000 procedures going back to 2008 (Figure 7). Of this total 13,822 were from procedures prior to More than 200,000 have been added since then due to the exponential growth in procedural totals recorded since inception, with an over twofold increase year over year from 2012 onward. Figure 7: AJRR Cumulative Procedural Volume Number of Procedures 250, , , ,000 50, ,326 2,833 6,730 13,822 45, , , The data included for analysis reflect cumulative data submitted between 2012 and 2014 only, unless otherwise noted. Due to the small number of hospitals and surgeons submitting data prior to 2012, data from these earlier years could be skewed by sampling error especially with regard to descriptive summaries of hospital, patient, or implant characteristics and therefore was not included in those analyses. Data presented in this Annual Report reflect N=211,721 procedures performed between 2012 and 2014, with the distribution of 60.9% knee procedures and 39.1% hip procedures. Patients included had a mean age of 66.5 years (Standard Deviation (SD) = 11.4) and were approximately 40.3% male and 59.7% female (Figures 8 11). The data in Figure 12 show the distribution of the major procedures (N=211,721) in AJRR s database. Includes 0.5% data entry and analysis error rate The data in Figures 8 and 9 come from N=236 contributing hospitals, one private practice, and one ASC. As expected, the distribution of hip and knee procedures approximates the national distribution as reported by the Centers for Disease Control and Prevention. ( 10 American Joint Replacement Registry 2014 Annual Report

13 Figures 8 and 9: Distribution of Hip and Knee Procedures and Gender Distribution of AJRR Procedures (N=211,721) Hip - Knee Knee n=128,880 (60.9%) Hip n=82,841 (39.1%) Gender Male n=85,315 (40.3%) Female n=126,406 (59.7%) Figures 10 and 11: Distribution of Total Sample by Joint Type and Gender (N=211,721) Hip (n=82,841) Knee (n=128,880) Revision Burden Revision burden is the number of revision arthroplasties performed during a year compared to the total number of arthroplasties performed that same year. While there is a relatively small number of early revision procedures within the first months post surgery that are revised the same year, most of the revisions reported in a single year involved arthroplasties placed in prior years. Nonetheless, revision burden can be tracked as a rough indicator of the procedure s overall success over time, and certainly serves as a relative measure of resources required because revision procedures are quite costly compared to primary procedures. In 2014 there was a total of n=8,257 hip revisions out of a total of 82,841 hip arthroplasty procedures of all types. This translates to an overall revision burden of 10.0% for hips. For knee arthroplasties, there were 10,420 revision procedures out of the total of 128,880 knee arthroplasties recorded, for a revision burden of 8.1% for knees. While there was slight variability from year to year, these numbers were relatively constant for hips (9.9% to 10.2%) with minor variation for knees (7.2% to 8.7%). Primary hip procedures include the following ICD-9 procedure codes: Resurfacing hip, total, acetabulum, and femoral head; Resurfacing hip, partial, femoral head; Resurfacing hip, partial, acetabulum; Total hip replacement; and Partial hip replacement. Male n=35,822 (43.2%) Female n=47,019 (56.8%) Male n=49,493 (38.4%) Female n=79,387 (61.6%) Figure 12: Distribution of Procedures (N=211,721) Primary Knee n=118,460 (56.0%) Primary Hip n=73,837 (34.9%) Revision Knee n=10,420 (4.9%) Revision Hip n=8,257 (3.9%) Hip Resurfacing n=747 (0.4%) Hip revisions include the following ICD-9 procedure codes: Revision of hip replacement, both acetabular and femoral components; Revision of hip replacement, acetabular component; Revision of hip replacement, femoral component; Revision of hip replacement, acetabular liner and/or femoral head only; Hip-bearing surface, metal-on-polyethylene; Revision of hip replacement, not otherwise specified. Primary knee procedures include the following ICD-9 procedure code: Total knee replacement. Knee revisions include the following ICD-9 procedure codes: Revision of knee replacement, total (all components); Revision of knee replacement, tibial component; Revision of knee replacement, femoral component; Revision of knee replacement, patellar component; Revision of total knee replacement, tibial insert (liner); Other repair of knee; Revision of knee replacement, not otherwise specified. American Joint Replacement Registry 2014 Annual Report 11

14 Hip Arthroplasty Procedural Data: Hips The mean age of hip arthroplasty patients was 67.0 years (SD 12.7), which is a slight decrease from last year s mean age of 67.6 years (Figure 13). It will be interesting in the years ahead to see if this small change over successive years remains consistent with the gradual decrease in mean age for hip arthroplasty reported by others over the past four decades 1. _ x = 67.6, SD = 12.8 Figure 13: Age Distribution of Hip Arthroplasty Procedures (N=82,841) 3,500 3,000 2,500 2,000 1,500 1, Number of Hip Arthroplasty Procedures Age of Patient Osteoarthritis was the diagnosis at the time of surgery for more than three out of four patients undergoing hip arthroplasty (Figure 14). Fractured femoral neck was the next most common, accounting for one in 10 arthroplasties performed. Rheumatoid arthritis, a very common diagnosis for THA in the past, now accounts for a mere fraction of one percent of these procedures 2 5. This is undoubtedly due to the dramatic effect newer medical options including diseasemodifying drugs have had on preserving joint function in the rheumatoid patient 2,6. Please note that the number of diagnosis codes does not equal the number of procedure codes because data may reflect a diagnosis code that does not match the procedure code (e.g., hip diagnosis for knee procedure). If that occurs but the components match the procedure code, AJRR does not count the diagnosis code. 12 American Joint Replacement Registry 2014 Annual Report

15 Figure 14: ICD-9 Diagnosis Codes for All Hip Arthroplasty Procedures (N=74,584) Figure 16: Hip Resurfacing As a Percentage of All Hip Arthroplasty Procedures by Year (N=747) 715: Osteoarthritis n=58,477 (78.4%) 820: Fracture of neck of femur n=7,947 (10.7%) Other n=4,009 (5.4%) : Avascular necrosis n=2,504 (3.4%) 996: Complications n=1,467 (2.0%) 714: Rheumatoid arthritis n=180 (0.2%) Other codes include those in categories 716, 719, 733, 736, 755. See Appendix D for complete list of diagnosis codes included in each category. Percent of All Hip Arthroplasty 2.5% 2.0% 1.5% 1.0% 0.5% 0.0% 2.0% 1.1% n= % n=109 n= Total hip arthroplasty accounted for nearly 80% of overall arthroplasties, while hemiarthroplasty and revision arthroplasties accounted for approximately 10% each (Figure 15). Hip resurfacing continues to be performed but has fallen to less than 1% of arthroplasties overall. This is a dramatic change, since in recent years resurfacing represented approximately 10% of all hip arthroplasties, with European countries and Australia reporting that hip resurfacing ranged between 6% to 9% of all hip arthroplasties 7,8. Figure 17: Gender Distribution of Hip Resurfacing Procedures (N=747) Male n=614 (82.20%) Female n=133 (17.80%) Figure 15: ICD-9 Procedure Codes for All Hip Procedures (N=82,841) 81.51: Total hip replacement n=65,879 (79.5%) 81.52: Partial hip replacement/ Hemiarthroplasty n=7,958 (9.6%) 00.7: Hip revision n=8,257 (10.0%) 00.8: Hip resurfacing n=747 (0.9%) See Appendix E for a complete listing of procedure codes included in each category. Hip Resurfacing Hip resurfacing has become highly concentrated to a very small number of centers and surgeons (Figure 16). Only 63 hospitals submitted resurfacing procedures. Three of those hospitals ( A, B, and C) accounted for n=443 (42.7%) of all resurfacing procedures. There were three surgeons who performed most or all of these resurfacing procedures (data not shown). One surgeon each at s A and B performed 100% of the resurfacing procedures and another surgeon performed 90% of procedures at C. Furthermore, Figure 17 shows that the majority (82.2%) of hip resurfacing procedures were conducted on males. Hip resurfacing was defined as any ICD-9 Procedure Code of 00.85, 00.86, or Hemiarthroplasty Arthroplasty for femoral neck fracture is an increasingly common procedure performed by both general orthopaedic surgeons and arthroplasty specialists. This is due to the shift in national demographics and the rise in the number of people over age 65. Analyses were conducted for hemiarthroplasty in only, as the reported incidence of this procedure was very small in In , a total of 214 hospitals submitted over 7,000 hemiarthroplasty procedures performed by 1,504 surgeons. As seen in Figures 18 and 19, 94.9% (6,810/7,175) of hemiarthroplasties were conducted for the diagnosis of femoral neck fracture. The remaining 5.1% of hemiarthroplasty (n=365) were conducted for more generic codes such as (pain in joint pelvic region and thigh) or the diagnosis was not reported. There also appears to be an increasing trend toward THA for patients with femoral neck fracture (Figure 19). The majority (69.3%) of hemiarthroplasties for femoral neck fractures were performed on females (data not shown). American Joint Replacement Registry 2014 Annual Report 13

16 Figure 18: Hemiarthroplasty As a Percentage of All Hip Arthroplasty Procedures in (N=7,175) Percent of All Hip Arthroplasty 12% 10% 8% 6% 4% 2% 0% 9.3% n=2, % n=4, Hemiarthroplasty was defined as any ICD-9 procedure code of Figure 19: Hemiarthroplasty and Total Hip Arthroplasty Performed for the Diagnosis of Femoral Neck Fracture (N=6,810) Percent of All Femoral Neck Fractures 100% 80% 60% 40% 20% 0% n=548 (17.9%) n=2,463 (80.3%) Hemiarthroplasty n=1,061 (19.1%) n=4,347 (78.3%) THA Diagnosis codes for femoral neck fracture included: Pathologic fracture, neck of femur and all codes included in 820 Fracture of neck of femur. Component Metrics: Hips Femoral head diameter choice at the time of hip arthroplasty has shown some increase for 36 mm sizes in this sample over the past three years. There is also a corresponding decrease in those less than 28 mm, with overall nearly 85% of heads measuring 32mm or larger for all three years (Table 2). Table 2: Frequency and Percentage of Femoral Head Sizes Implanted by Year (N=74,833) 2012 n(%) 2013 n(%) 2014 n(%) <28mm 537 (4.9) 704 (3.2) 1,176 (2.8) 28mm 1,049 (9.6) 2,902 (13.2) 5,752 (13.7) 32mm 3,112 (28.5) 6,025 (27.4) 10,790 (25.7) 36mm 4,890 (44.8) 9,828 (44.7) 19,607 (46.7) 40mm 808 (7.4) 1,165 (5.3) 2,225 (5.3) >40mm 515 (4.7) 1,363 (6.2) 2,435 (5.8) Total 10,911 21,987 41,985 Excludes hemiarthroplasty There has also been an increase in the use of ceramic femoral heads (versus cobalt chromium), which may be due both to the appeal of the improved wear properties of ceramic on conventional polyethylene but also very likely because of recent corrosion concerns with metal heads Available AJRR data show that in this sample of the U.S. experience there has been a steady and relatively rapid increase in the use of ceramic heads over the past three years, with ceramic heads currently utilized for nearly half of all hip arthroplasties (Figure 20). Figure 20: Composition of Femoral Heads (N=78,065) Percent of All Hip Arthroplasty 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% n=4,013 (38.7%) n=6,350 (61.3%) Cobalt Chromium n=10,689 (44.0%) n=13,613 (56.0%) n=21,254 (49.0%) Ceramic n=22,146 (51.0%) Ceramic head usage has been biased toward younger patients, accounting for the majority of all arthroplasties in those under age 60 and diminishing usage with each decade of advancing patient age thereafter (Figure 21). Since 2012, there has been a noticeable increase in ceramic head use overall mainly due to a rise in usage in younger patients: nearly three out of four patients in their 50s and younger receive ceramic heads. It is also the case that some surgeons tend to use ceramic heads preferentially for larger diameter balls. Data show a modest increase in usage of ceramic 36 mm heads compared to other head sizes (Figure 22). 14 American Joint Replacement Registry 2014 Annual Report

17 Figure 21: Ceramic Femoral Head Usage by Patient Decade of Life (N=35,956) Figure 23: Frequency and Percentage of Dual Mobility Cups Implanted by Year (N=1,386) 100% 8% Percent of All Primary Hip Arthroplasty 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 10s 20s 30s 40s 50s 60s 70s 80s 90s Patient Age by Decade of Life Percent of All Hip Arthroplasty 7% 6% 5% 4% 3% 2% 1% 0% 7.0% 7.0% 6.9% n=75 n=157 n= % 1.2% 1.1% n=164 n=251 n= Primary Revision Figure 22: Composition of Femoral Heads by Size (N=74,833) Percent of Implanted Femoral Heads 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 43.7% 56.3% 45.2% 54.8% Cobalt Chromium 51.7% 48.3% 28mm 32mm 36mm 40mm Femoral Head Size Ceramic 46.2% 53.8% Dual mobility articulations were developed in Europe and have gained interest recently in the United States due to the claim of enhanced hip stability and reduced risk of dislocation they provide Overall usage in this Registry cohort sample of the U.S. experience has been around 1.6% of all hip arthroplasties over the past three years. However, dual mobility cups were utilized in approximately 7.0% of all revision hip arthroplasties but only 1.3% of all primary THA procedures (Figure 23). As seen in Figure 24, use of enhanced polyethylene (either highly cross-linked or vitamin E impregnated) now accounts for the majority of hip arthroplasty procedures in the United States. This is certainly due, not only to earlier wear and osteolysis problems with conventional polyethylene, but also is in response to the availability of longer term data on the effectiveness of cross-linked polyethylene in reducing clinically evident wear and osteolysis AJRR believes the data in this section underrepresent the use of cross-linked polyethylene due to reporting ambiguity. As the detailed attributes of each implant code become available over the next year, greater data completeness and precision can be expected. Figure 24: Polyethylene Usage in Acetabular Liners (N=71,925) Number of Procedures 40,000 35,000 30,000 25,000 20,000 15,000 10,000 5,000 0 n=823 (7.7%) n=7,282 (68.3%) Cross-Linked Polyethylene n=2,561 (24.0%) n=2,355 (10.1%) n=7,784 (33.3%) n=13,241 (56.6%) Conventional Polyethylene n=4,428 (11.7%) n=11,552 (30.5%) n=21,899 (57.8%) Antioxidant Polyethylene American Joint Replacement Registry 2014 Annual Report 15

18 Revision Data: Hips Between 2012 and 2014, data were collected on 8,257 revision hip arthroplasties. Of these, 920 (11%) were linked revision arthroplasties where data on the earlier primary THA were also available in the Registry for analysis. Overall, in the larger cohort of 8,257 revision procedures, the predominant cause for revision by diagnosis code was aseptic mechanical, with the four codes for mechanical loosening, other mechanical, wear, and osteolysis (the last two which often co-exist and are interrelated) accounting together for 41.3% of revisions recorded (Figure 25). Dislocation was the next most common diagnosis, accounting for 13.9%, with infection (7.7%) and periprosthetic fracture (4.0%) less common. In the 920 linked hip arthroplasty revisions where data were also available on the original primary THA, over 70% occurred within the first three months post surgery (Table 3). This may be due to the relatively short period of data collection for this Registry from many of the AJRR participating hospitals. It may also be because of the likely bias toward early revision procedures, which is due to the likelihood of early failures returning to the original (AJRR participating) facility. This is compared to late revision cases that may be more often cared for at a different hospital, which may or may not be reporting to AJRR. Fewer than 7% of these linked procedures were revisions performed over one year post primary arthroplasty. Table 3: Time Interval between Primary Hip and Revision for Linked Patients (N=920) < 3 Months 3-6 Months 6-12 Months > 1 Year Therefore, the diagnoses that account for revision in this subset are clearly biased toward early cause of revision arthroplasty, which may be less often affected directly by the implant s performance and more related to surgical technique and patient comorbidities. Indeed, dislocation is the leading cause of failure in these largely early revisions, accounting for 20%, and it is closely followed by infection in 16%, and fracture in 13.2% (Figure 26). Dislocation and infection were the leading causes of early revision procedures following total hip arthroplasty (Figure 27). Figure 25: ICD-9 Diagnosis Codes for All Hip Revisions (N=8,257) : Mechanical loosening of prosthetic joint n=1,299 (15.7%) : Other mechanical complications n=1,323 (16.0%) : Dislocation of prosthetic joint n=1,149 (13.9%) : Infection and inflammatory reaction n=639 (7.7%) : Articular bearing surface wear n=521 (6.3%) : Peri-prosthetic fracture n=331 (4.0%) : Peri-prosthetic osteolysis n=269 (3.3%) All other codes n=2,726 (33.0%) Figure 26: ICD-9 Diagnosis Codes for Linked Hip Revisions (N=920) : Dislocation of prosthetic joint n=184 (20.0%) : Infection and inflammatory reaction n=147 (16.0%) : Peri-prosthetic fracture n=121 (13.2%) : Other mechanical complication n=55 (5.9%) : Mechanical loosening of prosthetic joint n=54 (5.9%) All other codes n=359 (39.0%) Figure 27: Most Frequently Reported ICD-9 Diagnosis Codes for Hip Revisions (<3 Months to Revision) Number of Early Hip Revision Procedures n=117 (17.4%) Dislocation of prosthetic joint n=114 (17.0%) Infection and inflammatory reaction due to internal joint prosthesis n=107 (15.9%) Peri-prosthetic fracture around prosthetic joint n=31 (4.6%) Other mechanical complication of prosthetic joint implant n=20 (3.0%) Mechanical loosening of prosthetic joint 16 American Joint Replacement Registry 2014 Annual Report

19 Knee Arthroplasty Procedural Data: Knees The mean age of patients having knee arthroplasty was 66.1 years (SD 10.4), which is similar to the mean age for hip arthroplasty (Figures 13 and 28). Findings demonstrate a slight decrease compared to last year when the mean age for knee arthroplasty was 66.7 years. It will be interesting in the years ahead to see if this small change continues to be consistent with the gradual decrease in mean age for hip arthroplasty reported by others over the past several decades 21. _ x = 67.6, SD = 12.8 Figure 28: Age Distribution of All Knee Procedures (N=128,880) 6,000 Number of Knee Arthroplasty Procedures 5,000 4,000 3,000 2,000 1, Age of Patient American Joint Replacement Registry 2014 Annual Report 17

20 Osteoarthritis was the underlying or original diagnosis for nearly 95% of knee arthroplasties, with rheumatoid arthritis accounting for a fraction of one percent of all arthroplasties performed (similar to the pattern in hip arthroplasty) (Figures 14 and 29). This is likely attributable to the impact disease-modifying drugs and other enhanced medical management strategies have on the preservation of major joint function in patients with inflammatory arthropathies 22. Revision procedures accounted for 8.1% of knee arthroplasties performed overall, with the rest primary arthroplasties of some type. Figure 29: ICD-9 Diagnosis Codes for All Primary and Revision Knee Arthroplasty (N=118,460) 715: Osteoarthritis n=112,187 (94.7%) 996: Complications n=1,690 (1.4%) Other n=4,251 (3.6%) 714: Rheumatoid arthritis n=332 (0.3%) Figure 30: ICD-9 Procedure Codes for All Knee Arthroplasty (N=128,880) 81.54: Total knee replacement n=118,345 (91.8%) 00.8: Revision knee replacement n=10,420 (8.1%) Other knee procedures n=115 (0.1%) Other codes include those in categories 716, 719, 733, 736, and 755. See Appendix F for complete listing of diagnosis codes included in each category. See Appendix G for complete listing of procedure codes included in each category. Please note that the number of diagnosis codes does not equal the number of procedure codes as a diagnosis code may be found that does not match the procedure code. If that occurs, and the components match the procedure code, the diagnosis code is not counted. Component Metrics: Knees Posterior stabilized type implants were the most frequent category used in primary knee arthroplasty procedures in this sample (Figures 31 and 32), accounting for approximately 58% over the three-year span. Cruciate retaining type implants were next most common and made up 30% of the total over the same time frame. Complex procedures requiring increased constraint or hinged devices made up only 2% of the total. Figure 31: Knee Implant Design by Year (N=125,554) 70% Percent of All Primary Knee Arthroplasty 60% 50% 40% 30% 20% 10% 0% 56.9% 29.9% 4.9% % 0.1% 6.3% 61% 27.3% 55.6% 31.7% 4.3% 5.7% 6.8% 4.2% 1.6% 0.1% 1.6% 0.1% Posterior Stabilized Cruciate Retaining Congruent Type Constrained Type Hinge Type Other/Unknown 18 American Joint Replacement Registry 2014 Annual Report