The number of total knee and hip replacements taking place in the United States is increasing each year. Approximately 518,000 total knee arthroplasties and 193,000 total hip arthroplasties are preformed yearly (American Academy of Orthopaedic Surgeons [AAOS], 2011a, 2011b) with a combined figure of 711,000. This number is expected to increase to 4 million by the year 2030 (Kurtz, Ong, Lau, Mowat, & Halpern, 2007). The total amount of yearly healthcare expenditures related to total knee arthroplasty and total hip arthroplasty procedures is estimated to exceed $65 billion by the year 2015 (Kurtz et al., 2007). The recent development of the American Joint Replacement Registry (AJRR) aims to monitor device performance, increase patient safety, generate cost savings, and determine the cost-effectiveness of these procedures (Press, 2009). Healthcare providers practicing within the specialty of orthopaedics need to be aware of the AJRR's existence, in addition to the valuable purposes it aims to serve and the goals it intends to achieve.

Development and History

The AAOS lobbied for several years for the development of a federally funded national device registry for hip and knee replacements. In 2009, the AJRR became a reality. The AJRR is considered an independent, nonprofit, 501(c) (3) organization for data collection and research pertaining to joint replacements of the hip and knee. The AJRR has been developed and funded by stakeholders who are advocates of the AJRR. These stakeholders include the AAOS, the American Association of Hip and Knee Surgeons, the Hip Society, the Knee Society, the Agency of Healthcare Research and Quality (AHRQ), the Centers for Medicare & Medicaid Services, hospitals, various patient advocacy groups, health insurers, and device manufacturers. The cost to initiate and develop the AJRR has been estimated to be $20 million to $25 million (Press, 2009). The AHRQ is slated to spend $12 million over a 4-year period and the AAOS has allocated $800,000 toward the development of the AJRR (Miller, 2009).

Purpose

The AHRQ anticipates that the AJRR will serve to improve the outcomes of patients and increase the quality and safety of care (Miller, 2009). This will be achieved by generating and advancing evidence-based knowledge pertaining to total joint replacement procedures and devices of the hip and knee (Miller, 2009). The AAOS feels that the AJRR will assist with reducing healthcare costs by identifying the most appropriate and effective treatment regimens for orthopaedic patients (Berry, 2011). Data that are collected from the AJRR will assist orthopaedic surgeons in identifying poorly performing implants in a more timely manner. The AJRR will also provide orthopaedic surgeons with feedback regarding their individual performance along with the long-term functioning of the specific implants that are being utilized (AAOS, 2012). Table 1 lists the specific purposes of the AJRR.

Table 1. Purposes of the American Joint Repla cement Registry

Comparative Effectiveness Research

The AJRR will be utilized to conduct comparative effectiveness research and address common questions and concerns voiced by experienced healthcare providers and economists, in addition to legislators, hospitals, and insurance payers (Lovette, 2011). These common questions and concerns consist of determining the effectiveness of costly joint replacement procedures. Are there other less costly treatment options just as effective as joint replacement procedures and, in spite of their effectiveness, are joint replacement procedures ideal for every patient? (Lovette, 2011). The lack of available evidence to determine effectiveness can have a strong bearing on healthcare costs (Lovette, 2011). Comparative effectiveness research looks for evidence that focuses on patients' individual perceptions, desires, and needs as a way to measure and assess the value of a specific treatment that ultimately allows healthcare providers to see the broader view when it comes to evaluating the effectiveness of procedures (Lovette, 2011).

Pilot Project Participants

Seventy-five hospitals, from a wide variety of settings across the United States, voluntarily agreed to participate in the first phase of the AJRR trial data collection process. Of the 75 hospitals, 16 were selected to participate in the initial phase of data collection, which started in early 2011. The 16 hospitals were chosen on the basis of diversity in relation to geographic location, size, and type of specialty practice (McKee, 2011a). The first phase of the data collection process lasted 3 months, which recently ended, and served as a pilot project to help the AJRR staff better understand what burdens of data collection existed and which data collection methods worked best for hospitals. This allowed for the AJRR to be better prepared for the initiation of the broad scale, nationwide joint registry later in 2011.

The issue of informed consent was identified during the pilot project. The importance of patient education pertaining to the registry was brought to the attention of the AJRR by participating hospitals that require patient consent before personal data can be gathered. The AJRR obtained commercial institutional review board approval. The AJRR also obtained a waiver of authorization and a waiver of informed consent in compliance with the Health Insurance Portability and Accountability Act of 1996 to conduct the data collection pilot; however, it was realized that some of the participating hospitals needed approval from their own institutional review board as well to participate in the program (McKee, 2011b).

Data Collection

Data collection for the AJRR will occur in levels. The initial phase of data collection is referred to as Level 1, which is followed by levels 2, 3, and 4. Each level consists of specific elements that will be added to the collection of data. The goal of the AJRR's collection strategy is to add elements of data in increments (Porucznik, 2011). Table 2 describes the AJRR levels of data collection.

Table 2. The American Joint Replacement Registry Levels of Data Collection

Level 1 data collection, which lasted for 3 months, consisted of data pertaining to the patient, surgeon, hospital, and procedure (McKee, 2011c). The patient-centered data comprised name, date of birth, social security number, diagnosis (International Classification of Diseases, Ninth Revision code), and sex. The surgeon data consisted of name and address. The hospital-related data were composed of the name and address of the facility. The procedure data encompassed the procedure code, date of surgery, implant information to include manufacturer and catalog number, laterality (right and/or left), and type of procedure (hip or knee). As of August 2011, participating hospitals have submitted data on more than 3,600 procedures to the AJRR (Porucznik, 2011).

Level 2 data consist of variables pertaining to the patients' body mass index, comorbidities, and antibiotic prophylaxis. These variables will strengthen the value of data analysis and allow for adjustment of risk (Porucznik, 2011). The data within Level 3 emphasize patient outcomes and satisfaction. Level 4 data focus on a comprehensive evaluation of how and why the failure of procedures or implants takes place.

Methods of Data Submission

The AJRR is going to utilize several modes for the submission of data. The methods will not be as laborious as earlier paper-based data entry systems and will help to minimize the burden of data entry. The modes will include the ability to obtain data from administrative claim forms, allowing existing orthopaedic registries to electronically submit data, and the utilization of interfacing with electronic medical records and healthcare information technology systems (Porucznik, 2011). Hospitals without electronic medical record software are able to enter data via a web-based application and any de-identified patient data are kept in a specific location on a sever that is compliant with the Health Insurance Portability and Accountability Act of 1996.

Goals

One of the goals of the AJRR is to attain participation of 90% of the approximately 5,000 hospitals nationwide by the year 2015 (McKee, 2011b). Additional goals align closely with the purpose of the AJRR. They include producing and promoting scientific knowledge of procedures pertaining to hip and knee replacement, improving patient safety, and encouraging positive patient outcomes, therefore increasing the overall quality of care among orthopaedic patients receiving knee and hip replacements.

International Registries

Prior to the development of the AJRR, the United States was one of the only developed countries that did not have a national joint replacement registry (Miller, 2009). For the AJRR to be beneficial to providers, patients, and U.S. healthcare system as a whole, evaluation of other international joint registries might prove to be advantageous. Developed countries such as Sweden, Britain, Canada, and Australia have had national joint replacement registries in place for several years now. These countries have been able to demonstrate the benefits of their registries and where changes have been made to improve the effectiveness and efficiency of their registries.

The Australian joint registry has seen an almost 10% reduction rate in the performance of total knee and total hip revisions since the implementation and utilization of a joint replacement registry, which has generated a significant cost savings (Wieting, 2011). The joint registry in England and Wales has been able to capture data from more than 95% of orthopaedic inpatient units (Wieting, 2011). The data collected by the England and Wales joint registry revealed that one hospital was employing 27 various types of femoral stems. Revealing this type of data allowed the hospital to generate cost savings and reduce redundant inventory by significantly reducing the number of different femoral stems that were being utilized.

The participation rates among international joint registries vary significantly among the individual nations. In New Zealand, participation in the joint replacement registry is mandatory. In the countries where participation is optional, there are varying percentages of participation. For example, in South Africa, there is 20% participation, and in Canada, there is 70% participation. Because of low participation and lack of support from the Minister of Health, South Africa has suspended their joint registry (Wieting, 2011).

Representatives from seven international orthopaedic associations were able to provide updates pertaining to their individual joint registries at the 12th Combined Meeting of Orthopaedic Associations, which was held September 13-17, 2010, in Glasgow, Scotland. This meeting revealed that each individual country has been able to generate information and collect outcomes data from their respective joint registries that have given them the ability to identify inferior-performing surgical devices and recognize poor surgical techniques (Wieting, 2011). The Australian registry reported that their data allow for a comparison among implants, which helps surgeons determine which implants are performing poorly. New Zealand registry reported the fact that the registry provides surgeons individually and confidentially with their rates of revision as compared with the national average. New Zealand's joint registry representative described this as outcomes data that are unbiased and powerful. New Zealand Orthopaedic Association has utilized the registry to create a local peer review process and identify orthopaedic surgeons who have unacceptable rates of revision or high complication rates so that performance improvement may be introduced (Wieting, 2011).

Conclusion

American Academy of Orthopaedic Surgeons. American Joint Replacement Registry Project. (2011a). Retrieved August 8, 2011, from http://www6.aaos.org/news/pemr/releases/release.cfm?releasenum=950[Context Link]

American Academy of Orthopaedic Surgeons. Total Hip Replacement. (2011b). Retrieved August 8, 2011, from http://orthoinfo.aaos.org/topic.cfm?topic=a00377[Context Link]

American Academy of Orthopaedic Surgeons. (2012). American Joint Replacement Registry project. Retrieved April 8, 2012, from http://www6.aaos.org/news/pemr/JointRegistry/JointRegistry.cfm[Context Link]

Berry D. (2011). The AAOS is facing "a technology moment." Retrieved September 28, 2011, from http://www.aaos.org/news/aaosnow/apr11/youraaos1.asp[Context Link]

Kurtz S., Ong K., Lau E., Mowat F., Halpern M. (2007). Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. Journal of Bone and Joint Surgery of America, 89(4), 780-785. [Context Link]

Kurtz S., Ong K., Schmier J., Mowat F., Saleh K., Dybvik E., Lau E. (2007). Future clinical and economic impact of revision total hip and knee arthroplasty. Journal of Bone and Joint Surgery of America, 89(Suppl. 3), 144-151. [Context Link]

Lovette M. (2011). Making the case for orthopaedic procedures. Retrieved August 14, 2011, from http://www.aaos.org/news/aaosnow/jul11/cover1.asp[Context Link]

McKee J. (2011a). AJRR launches pilot data collection program. Retrieved August 21, 2011, from http://www.aaos.org/news/aaosnow/jan11/research3.asp[Context Link]

McKee J. (2011b). U.S. joint registry has an exciting year. Retrieved August 20, 2011, from http://www.aaos.org/news/acadnews/2011/AAOS7_2_18.asp[Context Link]

McKee J. (2011c). AJRR launches pilot data collection project. Retrieved August 22, 2011, from http://www.aaos.org/news/aaosnow/jan11/research3.asp[Context Link]

Miller R. (2009). AHRQ to establish national joint replacement registry. Medical Devices Today. Retrieved August 9, 2011, from http://www.medicaldevicestoday.com/2009/07/ahrq-medical-device-orthopedic-nation[Context Link]

Porucznik M. (2011). AJRR completes data collection pilot project. Retrieved August 22, 2011, from http://www.aaos.org/news/aaosnow/aug11/advocacy1.asp[Context Link]

Press R. (2009). AAOS announces incorporation of American joint replacement registry. Retrieved August 13, 2011, from http://www.orthosupersite.com/view.aspx?rid=42122[Context Link]

Wieting M. (2011). Real-time, real-world data on hip and knee replacements. AAOS Now. Retrieved April 8, 2012, from http://www.aaos.org/news/aaosnow/jan11/research4.asp[Context Link]

For 58 additional continuing nursing education articles on orthopaedic topics, go to http://nursingcenter.com/ce.