Orthofix International N.V. Designs, develops, manufactures, markets, and distributes medical equipment used principally by musculoskeletal medical specialists for orthopedic applications. Ticker: OFIX Exchange: NASDAQ (See More NASDAQ Companies) Industry: Medical Appliances & Equipment (See More Medical Appliances & Equipment Companies) Sector. Annual Report 2018. Australian Orthopaedic Association National Joint Replacement Registry. AOA Home Page. Site maintained by the South Australian Health.
Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) was founded in 1998. It was introduced in a staged manner commencing in South Australia on the 1 st of September, 1999 and fully implemented across the country by mid 2002. In June 2009, Federal Parliament passed legislation to enable the government to recover funding costs from the orthopaedic industry. All data is validated against information reported to the government and by using this approach the AOANJRR obtains information on over 98% of hip and knee replacements undertaken in Australia, which is almost a complete dataset of hip and knee replacements.There are four types of data collected for each joint replacement. Type I data includes patient’s identification, basic patient details, type of joint replacement, primary or revision arthroplasty, details of the prostheses, and the identity of the hospital and surgeon. This data is the basic and minimum data set required, it also has been proven to be the most useful to date. It can be analyzed for survival rate/revision rate for different arthroplasties, which can be interpreted in all aspects of arthroplasty, particularly in the quality and utility of different prostheses.
Type II data is about additional data on the patient, which includes: perioperative treatment (antibiotics and anticoagulants), comorbidities, the American Society of Anesthesiologists Physical Status classification system (ASAs) score, surgical approach, the use of computer-assisted surgery and many more. This data is widely collected by many joint registries and can provide useful clinic information that can direct clinical treatment perioperatively. Type III data includes post-operative clinical assessment as well as patient-reported pain, function and satisfaction.
Type IV data includes radiographic data which is heavily utilised by surgeons. The usability of the later two types of data are not fully disclosed or extensively reported. This is due to the labour intensive requirements for collecting these two types of data.
For this reason the last two types of data are usually the focus of institutional registries and not the national joint registry.Many hospitals or medical care groups hold their own database for joint replacements, these institutional registries collect all types of data and can give precise and valuable information including reports of longitudinal institutional experience and individual case findings, which are especially useful for unusual complications or comorbidities. This data has been used to influence changes in clinical practice with improvement in clinical care. These institutional registries, therefore, are excellent platforms for clinical prospective and retrospective research. Compared to the institutional registries, the national joint registry has the ability to provide more valuable information for national health care insurance and policy makers, such as: (I) very detailed information on patterns of implant usage and performance; (II) surveillance of implants performance that is nation wide and across all surgeons; (III) identification of the behavior of new implants with the ability to detect earlier outlier implant performance, which is almost impossible using smaller institutional based registries. Cumulative percent revision for dislocation of primary total conventional hip replacement by primary diagnosis and head size.Over recent decades, the data from the joint registry supports cemented fixation.
The 2013 report also showed cemented fixations had lower revision rates compared to cementless fixation. After advancements in surgical skills and technique as well as implant improvements, the 2014 report appears to provide a breaking point in this argument. The hybrid fixation is still the best choice in THA for OA, but cementless fixation demonstrates an advantage after 3 years. The cumulative revision at 13 years is 6.7% for hybrid, 7.1% for cementless and 9.0% for cemented fixation.
Following these results, we suggest a cementless acetabular cup for all cases, and then surgeon’s preference for either a cemented or cementless femoral stem. Cumulative percent revision of primary total conventional hip replacement by fixation (primary diagnosis OA).In the area of bearing surfaces, it has been demonstrated that the cross-linked polyethylene (XLPE) is superior to non cross-linked polyethylene , this advantage increases with time and the cumulative revision rate at thirteen years is 4.7% and 9.2% respectively. Although the ceramic bearing surface has large theoretical advantages of less wearing, this advantage has not correlated into clinic advantage, metal/XLPE has the lowest revision rate (4.7%) compared to the alternatives over a 13-year cumulative revision rate. Following these data and the reality of our country, we recommend a 32 mm metal femoral head with XLPE as the treatment of choice for Chinese patients because of its relative lower price and better survival. Cumulative percent revision of primary total conventional hip replacement by bearing surface (primary diagnosis OA).The 2014 annual report contains 480,440 knee replacements, with an additional 51,212 replacements compared to the 2013 annual report.
Although knee replacement is mature technique useful in treating many clinical problems for all kinds of patients, there are still some controversies to be resolved.Unicompartmental knee arthroplasty (UKA) has become more and more popular in adult reconstruction, the advocators believe it is less invasive, allows quicker rehabilitation and better satisfaction compared with total knee replacements. Unicompartmental knee arthroplasty is rare in Australia compared with other countries in the world with only 41,250 (8.59%) over 13 years and the use of UKA continues to decline. In 2013, the number of UKA decreased by 2.7% compared to 2012 and 49.5% compared to 2003. As a percentage of all knee arthroplasties, UKA has decreased from 14.5% in 2003 to 4.1% in 2013.
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The reason for this phenomenon is that the revision rate of UKA is much higher than TKA, the cumulative revision rate of UKA’s undertaken for osteoarthritis was 19.1% at 13 years , and this revision rate is unacceptably high compared to TKAs (6.8% for OA at 13 years), The first reason for revision is not the progression of OA, which surgeons were concerned about, but the loosening/lysis of the prosthesis (45.3%). Cumulative percent revision of primary unicompartmental knee replacement (primary diagnosis OA).The need for patellar replacement in TKA is still a question that has not been solved over the decades. The 2013 annual report disclosed a lower rate of revision following primary total knee replacement when patellar prosthesis is used. This data has undergone detailed analysis in the 2014 annual report. For rheumatoid arthritis, the revision rate for patella replacement versus no patella replacement was 5.4% and 6.0% at 13 years respectively, which is of no statistical significance.
For osteoarthritis, the revision rate for patella use versus no patella use was 6.0% and 7.4% respectively. The higher rate of revision when patella prosthesis is not used was due to, increased revision for patellofemoral pain, pain, and patella erosion, as patellofemoral pain was rare with a patella replacement. Revision diagnosis cumulative incidence of primary total knee replacement by patella usage (primary diagnosis OA).Whether the surgeon needs to resect the PCL during TKA has also been debated for decades. The choice for PCL resection affects the stability of the implants; cruciate retention (CR) implants have less stability than cruciate sacrificing (CS) implants.
In China, CS implants are the more popular choice, but in Australia, CR implants are the first choice except for more complicated cases, the reason for this is the revision rate of CS implants is always higher than CR implants. When we consider both the stability of the knee and patella replacements, the results from the AOANJRR demonstrate that CR TKA with a patella replacement have the lowest revision rate compared to the other three combinations. Cumulative percent revision of primary total knee replacement by stability and patella usage (primary diagnosis OA).Fixed bearing prosthesis have been utilised in clinic for decades and produces wonderful results, but there exists a paradox between compatibility and constriction, higher compatibility brings out higher constriction which will cause greater loosening.
Mobile bearing surfaces were invented to resolve this problem, allowing a combination of high compatibility while limiting constriction. Mobile bearing, therefore, theoretically appears to be the better choice in TKA. The AOANJRR reports do not support these theoretical merits.
The data demonstrates that the revision rate of mobile bearing prostheses is higher than fixed bearing prostheses. This is the reason why fixed bearing is still the treatment of choice in Australia. Cumulative percent revision of primary total knee replacement by bearing mobility (primary diagnosis OA).We have discussed some topics that continue to be widely debated worldwide, these topics have yet to reach a consensus and require further investigation. The data from the joint registry have many more cases than clinical trials and meta-analysis because they are generated from national databases, making the findings more compelling when the government formulates healthcare policy. In Australian public hospitals where the government covers all the healthcare expenses, the surgeon should use reliable implants and would be required to justify their reason for choosing an implant with higher revision rates.
Although the data reports from the AOANJRR are not legally binding mandates dictating surgeon choice of prosthesis, they do give surgeons valuable information that cannot be elucidated through clinic trial and meta-analyses alone.The joint registry does not give the surgeons the answers to all the clinical questions and the data from the joint registry cannot tell surgeons the functional outcomes of the operations. The joint registry also does not analyse all the radiographs during the operation and follow-up. The joint registry is not a good platform for clinic research as it can only give us retrospective data, although the data can be retrieved much more quickly than these through clinic trials. For this reason there will always be a need for ongoing clinical trials looking for answers to specific clinical questions.A new difficult situation has been raised, the data in the AOANJRR regarding revision rate is calculated using Kaplan-Meier analysis, but in recent articles in Clinical Orthopaedic Related Research (CORR) some researchers have found the Kaplan-Meier analysis may overestimate the risk of revision in arthroplasty (,). Although we have not confirmed the conclusions from these articles, it is definitely a question worthy of further investigation. Fortunately, AOANJRR has reported on this problem and the need to consider competing risk with death particular as the follow up time increases.
However, it is important to understand that the relative comparison remains whether or not the risk is overestimated as it is overestimated equally in all groups being compared.Another limitation of this article is all the data analysed is from the AOANJRR, where the data is derived from Australia, which is inherently different to the Chinese race and culture. There are some differences between the two races, such as a higher BMI in Australia and a lower incidence of osteoarthritis in China where the main indications for THA is femoral neck fractures and femoral head avascular necrosis. Most of AOANJRR data is from THA for osteoarthritis and so there may be some differences in outcomes among different diagnoses. Furthermore, Chinese patients often have more serious deformities and functional problems prior to undergoing the total joint arthroplasty because of the differences in healthcare systems that also impacts on the results and revision rate of arthroplasties.We must emphasize that our analysis and interpretation of the AOANJRR are based on the authors’ personal understanding and clinical knowledge. All the data are from AOANJRR 2014 annual report, the readers can download the free report from the official website and check the data you are interested in. We are happy to discuss differences of opinion if you have some alternative suggestions.
June 3, 2019 – / ORTHOWORLD’s Market AnalystOrthopedic industry revenue reached $51 billion worldwide in 2018 and grew 3.5% over 2017, according to estimates from published by ORTHOWORLD.Orthopedic device companies faced familiar challenges in 2018. Payors, regulators and customers are demanding better clinical and economic outcomes, while legacy product lines are becoming commoditized and price erosion is impacting all segments of the orthopedic market.These pressures promise to be part of the orthopedic landscape for the foreseeable future, and in 2018 many companies refined their strategies to deal with the ongoing transformation of healthcare. Results were mixed among the largest companies as some stumbled operationally while others overperformed, due in part to early adoption of technology and entry into high-growth segments.Common strategic themes present in 2018 that will continue as part of the industry’s narrative in 2019 and beyond include connected ecosystems of products, flagship technology (e.g. Robotics), portfolio-wide pull through and a growing shift to outpatient procedures.Large companies are racing to build a connected ecosystem of products with a flagship technology, whether robotic or software-based, at its core. These systems aim to provide comprehensive solutions throughout the episode of care and offer the surgeon tools to improve procedure flow through analytics and pre-op planning; reduce waste; enable predictable, repeatable clinical outcomes and monitor patient rehabilitation.These ecosystems allow orthopedic companies to monopolize operating rooms and increase the disruptive cost of customers switching to other providers. Flagship technologies, particularly robotics, have been shown to be a significant factor in generating improved sales mix as they facilitate implant upselling and portfolio-wide pull through.As the ecosystem strategy creates opportunities to take market share and improve sales mix, companies strive to be ready with a robust portfolio of up-to-date implants.
Many players will pursue aggressive product launch cadences in 2019. Those with strong balance sheets may opt to buy their way into a differentiated product line, as we saw with Stryker’s acquisition of K2M and Smith & Nephew’s tuck-in acquisitions of Brainlab’s joint recon business, Ceterix Orthopaedics and Osiris Therapeutics in 1Q19.A focus on outpatient centers offers an alternate growth vector for companies that either lack the resources to develop or purchase a robotics solution, or feel like the significant capital investment required of robotics is not a good fit for their customers. Like robotics, selling strategies for ambulatory surgery centers (ASCs) or hospital outpatient centers is a relatively new endeavor for orthopedic companies. Outpatient procedures, particularly in the U.S., are expected to rapidly grow as surgeons and ASCs demonstrate evidence of safety and efficiency and payors provide favorable reimbursement.Device company leadership has voiced some uncertainty about the rate of growth. Some surgeons have shared that they’ve received pushback from hospital administrators to not move procedures to an outpatient setting due to lower reimbursement. It’s largely expected that payors will align with the outpatient movement, and once that happens, procedures will move. Companies focusing in this area now will develop advantages over competitors as they’re able to refine outpatient-specific selling strategies.Wright Medical CFO Lance Berry recently summarized the nuances of selling to outpatient centers, saying, “The cost of the product is part of it, but also, how do they keep their O.R.s full?
That’s their biggest cost. And how do they attract the type of procedures and patients that they want to fill up the O.R.? What can you do to help them with their efficiency? And then they want options, and they’re willing to pay fine gross margins for the different options, but they may want a lower-cost option and a higher-cost option that they will make some decisions around. So, it’s not as simple as price.”.