direct Agenda Quality versus cost pressure: Professor Joachim Hassenpfl ug and Günter Ploss discuss co-payment models for joint replacement

Transcription

1 direct Magazine for Endoprosthetics Issue Agenda Quality versus cost pressure: Professor Joachim Hassenpfl ug and Günter Ploss discuss co-payment models for joint replacement

2 Cleanroom The cover photos give an insight into the strict quality assurance system in place at Link. This page shows two employees packing implants in the cleanroom after final cleaning.

3 Dear Readers, Editorial Many of you will have been surprised to see the new look of the anniversary issue of directlink. But we didn t stop at layout; as you read on you will notice changes in content as well as form. This issue introduces the Hamburg roundtable. Its purpose is to provide a platform to express different views relating to topical issues in the field of arthroplasty. In the first meeting, Professor Joachim Hassenpflug, Director of Orthopedics at Orthopedic University Hospital Kiel, and Günter Ploss, who holds a degree in Business Administration and is Head of the Hamburg office of vdek, the Association of Alternative Health Insurance Funds, discuss cost pressure versus quality. Our guests debated whether co-payment models for joint replacement can solve the current dilemma or whether only an arthroplasty registry can drive inferior implants out of the market that is, if the registry ever arrives. Despite holding conflicting views on some points, all participants agreed that quality and, by extension, best-possible patient care must be the ultimate aim of orthopedic practice. I would love to know what you think of our Hamburg roundtable. Please send in your thoughts to our editorial team at: redaktiondirectlink@linkhh.de Stick with us, Helmut D. Link 03 Contents Forum 04: Resentment over decision on the sales taxation of prostheses for joint replacement 05: Prof. Dr. Norbert Roeder from University Hospital Münster on why hospitals should negotiate additional payments 06: Link extends its partnership with tradition-steeped Stanmore Hospital 07: This year s key diary dates at a glance 26: New look magazine gets positive feedback Agenda 08: Prof. Joachim Hassenpflug, Director of the Orthopedic University Hospital Kiel, and Günter Ploss, Head of the Hamburg office of vdek, the Association of Alternative Health Insurance Funds, meet for the first Hamburg roundtable on whether co-payment models can ensure better patient care Technology 14: SimpleClean is revolutionizing the market in surgical instruments 14: Stack finger splints: The undisputed gold standard 15: Female knee delivers no better results 15: Sled prosthesis giving excellent long-term results 16: Implant researcher Dr. Jan Philippe Kretzer talks about the medical relevance of wear tests 18: New instruments for Gemini SL plus an interview with Prof. Maurilio Marcacci from the University of Bologna Practice 20: Prof. Dr. Christoph Ulrich from Klinik am Eichert, Göppingen, on knee revisions 22: Cemented or cementless hip revision stems? An interview with Dr. Wolfgang Klauser from Endo-Klinik Hamburg 24: Dr. Uwe-Karsten Schöbel from Görlitz Municipal Hospital accepts no compromise when choosing joint implants

4 Forum 7 % sales tax 19 % sales tax 04 Resentment over sales tax decision There has been uncertainty since the beginning of this year concerning the different sales tax treatment of artifi cial joints and joint components on the one hand and implant parts and accessories on the other. BVMed, the German Medical Technology Association, sees it as the legislator s duty to change tax law. On 1 April 2008 the German Federal Finance Court returned its decision on the sales taxation of joint implants. The judges insisted that manufacturers and suppliers apply the standard sales tax rate of 19% to parts and accessories. Entire artificial joints and joint components are still subject to the 7% sales tax rate. 12% sales tax loading for parts and accessories Clinics which are not entitled to deduct sales tax will feel the impact of the decision most. Since the beginning of the year they must pay 12% more sales tax if, for example, they only purchase heads, stems, cups or inlays, the reason being that, on their own, these elements of a hip implant are not considered discrete prostheses, and therefore do not qualify for the lower rate of sales tax. Components like artificial femurs (stem and femoral head) or artificial acetabula (cup and inlay) are taxed at the lower rate because they replace a natural body part in and of themselves. Given the modularity and variety of replacements, this decision is incomprehensible to many people concerned, says Joachim M. Schmitt, Director General of BVMed, the German Medical Technology Association. Therefore, we advocate a 7% tax rate for joint replacement across the board, as does the German Hospital Organization. Right after the general election, we will be speaking to the politicians in charge and step up our push for a change in the sales tax regulations. Link offers support to clinics However, for the time being, manufacturers and suppliers are obliged to abide by the current law. Clinics should therefore be sure only to buy in entire joint implants or joint components as defined by the Sales Tax Act, is the advice of Peter Willenborg, Commercial Director at Link. We will be supporting our customers in this matter and inform them if we see ways for them to save on their order. He also said that Link sales representatives were aware of the new legal framework and would be available to answer clinics questions.

5 Additional payments increase hospital revenue Hospitals can negotiate extra payments for certain services in addition to the fl at rates per case. Yet many clinics fail to avail themselves of this opportunity. Professor Dr. med. Norbert Roeder, Chairman of the Board and Medical Director of University Hospital Münster and Head of its DRG Research Group explains, what they are missing out on. Prof. Dr. Roeder, what is the purpose of the additional payment scheme in the DRG system? For some treatments within a DRG flat rate classification, some patients require expensive implants or medication. If these products were to be calculated in the DRG case rates, the average payment would not cover the costs of complicated cases while it would more than cover the cost of straightforward cases. For that reason, the price of the expensive product is paid on top of the DRG. The additional payment designated ZE for modular implants is defined as follows in the German Procedures Code (OPS) Version 2009 OPS code: d OPS text: Other arthroplastic procedures: Implantation or revision of modular implants in the case of bone defects involving joint and/or (partial) bone replacement or customized implants (...). Note: (...) Modular implants comprise three or more separate metallic parts on at least one arthroplastic component; the head does not count in the case of a hip implant. For which arthroplastic implants can additional payments be negotiated with insurers? The 2009 DRG system includes additional payments covering implants for vertebral body replacement, for the distraction nail, for pelvic implants and for modular implants. Why is it worthwhile for hospitals to claim additional payments? Additional payments are fixed reimbursements in the German hospital financing system. Those who do not invoice additional payments for eligible services are forgoing reimbursements to which they are entitled. Do additional payments increase the clinic s budget? Yes. Additional payments form part of the general agreement between hospital and insurer. As of 2009 clinics and health insurance companies negotiate the quantity and type of flat rate, and the quantity and type of additional payment. The quantity multiplied by the relevant fees gives what is called the revenue budget, so the more additional payments a clinic has negotiated, the higher the budget will be. For the rest, the individual DRG fees per case are fixed as standard for a federal state. Are there any other ways for a hospital to increase its budget? Apart from the additional payments fixed in the DRG and additional payment catalogue, it is possible to apply once a year to the DRG institute InEK for surcharges for new examination and treatment services (NUB). If InEK upholds the application, fees for new services that are not yet covered by the DRG or additional payment system can be negotiated locally between hospital and health insurance companies. These services are financed off-budget. It is very important for doctors to draw administrators attention to new treatments in time for the applications to be written and tabled in the fee negotiations. 05

6 Forum Strong partnership with Stanmore Hospital 06 We are very happy, says Kim Hubert about the long-standing partnership with the renowned Stanmore Hospital in London. The Head of Exports at Link in Hamburg goes on to say that they are contemplating strengthening the ties further. The Royal National Orthopaedic Hospital, RNOH for short, uses the modular cementless MP Hip Revision Stem from Link. One in five UK orthopedic surgeons receives training at Stanmore Hospital. Its scientific and practical facilities make RNOH one of the foremost centers of excellence in the world. In this respect, the partnership with Link fits in very well with the firm s great tradition. Our links with RNOH are based on the vast experience in orthopedics the RNOH has accumulated, explains Kim Hubert, stressing that Stanmore Hospital is a source of technical innovation with a strong scientific focus. The Royal Hospital came into being in 1905 as a result of the amalgamation of three specialist orthopedic hospitals. Its impressive his tory of orthopedic practice, research and training stretches back to Today it is based in the London district of Westminster, with the main site located in Brockley Hill, Stanmore. First-class research, practice and training The MP implant used at RNOH as part of the hospital s partnership with the Hamburg-based arthroplasty specialist was designed to revise hip prostheses in cases of extensive proximal bone loss. Many orthopedic surgeons from abroad, visiting the RNOH for training purposes, stand to benefit from the ties with Link. It is already clear at this point that follow-up studies will give greater insight in future on the preoperative and postoperative results achieved with Link implants. Incidentally, one of the hospital s highest profile patients was the former British Formula 1 racing driver Graham Hill. He broke multiple bones in both legs during the Grand Prix in Watkins Glen, New York in October 1969, and was subsequently treated at Stanmore.

7 Diary dates 2009 Preserving mobility Events run by the Arthroplasty Working Group How can physical mobility be preserved or restored? This is the central question addressed by the AE Arthroplasty Working Group (Arbeitsgemeinschaft Endoprothetik) a pool of leading orthopedic surgeons, traumatologists and scientists from around the German-speaking regions. These experts deal with issues in arthroplasty and alternative procedures. For a year now, Link has been the scientific group s partner. Here are the dates of the Arthroplasty Working Group s upcoming seminars and workshops: AE master class in hip revision June Congress Centrum Damp AE seminar on the shoulder July Maritim Hotel Stuttgart AE tri-nations seminar on the knee August Kitzbühel/Austria AE seminar on the hand September Oberstdorf AE tri-nations seminar on the hip and hip revision 1 3 October Lucerne/Switzerland AE seminar and master class in the knee November Ofterschwang AE conference 4 5 December Magdeburg Further information is available at Link International Symposium The Link international symposia have for many years been a welcome opportunity for surgeons from home and abroad to find out about and discuss the very latest developments and experiences with the product range from the Hamburgbased firm. The symposia focus on practical and practice-related topics in hip and knee surgery using minimally invasive techniques for the purpose of correctly reproducing intact joint architecture from a physiological point of view. Once again, Link is putting on a series of training sessions tailored to specific target groups in conjunction with Endo-Klinik Hamburg, all of which will take place in Hamburg and Norderstedt. Each of the Link international symposia will deal with different product groups, and the dates are as follows: 1 2 October MP hip revision stem Endo-Model sled prosthesis Endo-Model rotating hinge knee prosthesis Closing date for registration: 24 August 5 6 November C.F.P./T.O.P. cementless hip system Endo-Model sled prosthesis Endo-Model rotating hinge knee prosthesis Closing date for registration: 28 August 3 4 December MP hip revision stem Endo-Model rotating hinge knee prosthesis Closing date for registration: 10 October Further information and registration: Rainer Robert Rostin Customer Relationship Manager Tel.: 0049 (0)40/ Fax: 0049 (0)40/ RR.rostin@linkhh.de 07

8 Agenda 08 Case rates force clinics to buy in cheaper products

9 Cost pressure versus quality: Can co-payment models for joint replacement solve the dilemma? Or can only an arthroplasty registry drive inferior implants out of the market, that is if the registry ever arrives? At this, the fi rst direktlink Hamburg roundtable, Prof. Joachim Hassenpflug from Orthopedic University Hospital Kiel and Günter Ploss, Head of the Hamburg offi ce of vdek, debate the issue. Moderation: Holger Iburg directlink: The situation in dentistry is that patients who contribute towards the cost of restoration receive better treatments and better products. This option does not exist for hip or knee replacement. The patient has no choice. Why not, Mr. Ploss? Günter Ploss: Because as a statutory health insurer we have an expansive in-kind principle, which finances medically necessary and state-of the-art services through people s statutory health insurance premiums. With dental restoration, however, there was much dispute in the past over whether this service can and should be covered by the statutory health insurance. Besides, I would not agree that this form of financing guarantees better quality of care. On the subject of best standard of care: are we providing it, Professor Hassenpflug? Prof. Dr. med. Joachim Hassenpflug: Yes, the standard of care is very high in arthroplasty in particular. While not all patients are entirely free of complaints, no revision is necessary within ten years in 95% to 98% of cases. This applies to knee and hip implants. Nevertheless, demand is rising, one of the reasons being our aging population, an-other being 40- to 50-year-olds with high expectations. Does cost pressure force people to accept implants of somewhat lower quality? Ploss: If I understand it correctly, we have around 450 different models of hip implant in the field of Different points of view, yet plenty of common ground: Günter Ploss (left) and Joachim Hassenpflug arthroplasty. I think that ways of cost reduction are still open to providers, although one must consider that every patient s joints are different and so the replacements must be different. But I do see scope for reductions. To press the point, does cost pressure force the use of products of inferior quality? Hassenpflug: I wouldn t say inferior. This situation is that revenue for an implantation is fixed You mean the case rates. Hassenpflug: Exactly. In light of that, it is in the medical interests of every facility and hospital to optimize costs and to select the most economical implant. Can you give examples? Hassenpflug: Well, if we look purely at the costs of the implant: the lower the price at which the implant is bought in, the lower the operating costs of the hospital. What you re saying is, then, that cost pressure compels a hospital to buy economy in order to run the hospital cost-effectively? Hassenpflug: Basically, the flat rates force hospitals to buy in not inferior but better value products and effectively rule out the more expensive but higher quality products due to the price pressure inherent in the tendering process. Ploss: Not necessarily. If one thinks long-term, taking different factors into consideration, an expensive implant doesn t necessarily turn out to be the most expensive option. Over the entire chain of supply, it may be just as economical or even more so. Longer life, no rehab, no physiotherapy and so on. Hassen- 09

10 Agenda I don t agree with the view that we do not provide effective care in arthroplasty because too little is paid. Günter Ploss 10 Günter Ploss (61), who holds a degree in Business Administration, is a well-known expert in the German health system. For eleven years he ran the Schleswig-Holstein office of vdek, the Association of Alternative Health Insurance Funds, and has been head of the Hamburg office since Since 1993, Ploss has been a member of the representatives assembly of the BfA, the Federal Insurance Institute for Salaried Employees, (now Deutsche Rentenversicherung Bund, the German Pension Insurance Association) and speaker of the Salaried Employee Fraction or Trade Union Fraction on the Insurer Committee. pflug: Shouldn t long-term performance be one of the evaluation criteria then? Ploss: Yes. I m very much in favor of a quality assurance system. However, tendering in Germany often comes down to price more than quality simply because of the pressure the case rates bring to bear. Ploss: Definitely not low-price, but economical, yes. And, of course, the health insurance companies do not fix the case rates. They are set out jointly and then published. But it s the case rates that effectively force the buyers hand. And one ends up with a reasonably priced product with a shorter life instead of a higher quality implant. This is where the long term aspect, as you ve mentioned, comes into play, because it is actually much more costeffective if fewer revisions are required in the long term. Hassenpflug: But to assess that, quality must be measured in the long-term. And another factor is for performance data on the innovations and on the implants which are initially more expensive in the introductory phase to be backed by unequivocal quality documentation and not just wishful thinking. We know all too well that there are certain cycles in arthroplasty, such as changes of model. These are not always quality-driven, but, with-out going into it, there are many other reasons for them. And when we are working with innovations, it is essential for the higher quality of those innovations to be proven beyond all doubt. But we don t have this data yet. The data is not available in Germany but the Scandinavian registries do have it.

11 Prof. Dr. Joachim Hassenpflug (59) has been Director of the Orthopedic University Hospital Kiel since He was President of the German Society of Orthopedics and Orthopedic Surgery (DGOOC) and a permanent advisor and administrator of the DGOOC s arthroplasty registry. Hassenpflug: We cannot simply take the data out of context and apply it to Germany. Besides, in Sweden for instance, we re talking figures from over a period of more than ten years, numbers which we have in one year here. The scale is quite different. Ploss: It s true, we need a system of quality assurance, and for that we have to introduce an arthroplasty registry. Unfortunately, quality assurance is in its infancy in many areas of medicine. While quality assurance has become a given in the inpatient area in my opinion, there is a lot to be desired in the outpatient area. One has to look at who is good and who is producing good quality. And a good product is no good in the hands of the wrong surgeon. Hassenpflug: I think we all agree on this. A quality assurance registry would reveal things like quality, down to the indivi-dual hospital, and surgeon. I think we owe the patient much more transparency in this regard as well, to put the data on the table so to speak. Who is holding up the introduction of a registry? Ploss: There are many parties with different interests. Of course, the main ones against it are those who are afraid they will go by the wayside. That is, those who are delivering bad quality, be it on the medical side or on the product side. Hassenpflug: Basically, the fl at rates force clinics to buy in not inferior but better value products. Prof. Hassenpfl ug I take the view that it has fallen victim to administrative buck-passing at the expense of all involved in medicine. It s unfortunate. We are letting valuable information go unrecorded, which means that every year a large number of patients have to suffer complications. 350,000 prostheses a year are implanted in Germany. This high number of primary procedures and the failures that occur impact on many an individual s fate, sometimes severely. Would a registry convince the buyers to purchase higher quality implants? Hassenpflug: Let s assume I implant 10,000 prostheses and 500 of them go wrong. If things are transparent, my buyer will come to me and ask what the problem is. If I implant 10,000 and only 50 go wrong, the marketing department will try to put a positive spin on it. The registry is an ideal source of truly measurable, objective data. 11

12 Interview Agenda 12 That s a firm call for politicians to intervene in a regulatory capacity. But all the politicians we asked to join in the roundtable demurred. Prof. Hassenpflug, you spoke about the conflict in the hospitals between doctors and administrators. How would you solve the conflict? Hassenpflug: It s a difficult issue. The tighter the constraints, the greater the conflict. Of course, there are large highly specialized facilities which perform a great many procedures of the same kind. They naturally have an advantage in being able to rationalize, but also the disadvantage that while they understand a lot about one thing, they might know less about something else. Patients do not always fit into neat little boxes, so one must be flexible to their needs. Doesn t this suggest that the patient should be given the option of buying the bestpossible replacement through co-payment or deductible? Ploss: I repeat, I don t consider this a viable solution. But isn t it true that we have a problem with customized prostheses in particular, because it only pays in the large specialized hospitals if at all? Hassenpflug: It pays in the large hospitals on account of economic dilution. But when hospitals mainly do complex cases, there are no dilution effects and then this type of replacement becomes problematic. Especially when medical decisions are based on economic considerations. The When we are working with innovations, it is essential for the higher quality of those innovations to be proven beyond all doubt. Prof. Hassenpfl ug Weighty arguments: Günter Ploss, Dr. Holger Iburg, Professor Joachim Hassenflug (l. to r.) patients are extremely vulnerable here because they don t have the means to question the information critically. But nor can it be in the insurers interests to save to such an extent that the best-possible care isn t provided. Why shouldn t patients see to the own well-being by paying a deductible? Ploss: I don t agree with the view that we do not provide effective care in arthroplasty because too little is paid. And if it were a problem, it would not be solved by introducing a deductible because the patient, as you ve said yourself, is not in a position to make a judgment on the medical service. Hassenpflug: Correct. Ploss: And if the doctor puts the patient under financial pressure as well, it becomes a serious problem. We see this with outpatient individual health services not covered by state health insurance, known in Germany as

13 We need a system of quality assurance, and for that we have to introduce an arthroplasty registry. Günter Ploss highest quality hip because it s the best in the long term or the patient can decide to opt for the highest quality option because he or she wants the gold standard? Ploss: Which the surgeon says is the highest quality option Hassenpflug: if he had the figures. Ploss: It is hard to tell at this point what consequences this would have for a health system based on the solidarity principle. I would tend to fear the worst. You both say we don t know when we will have the registry. Mr. Ploss, you say it may take 20 years. Prof. Hassenpflug, you say we ll have the data earlier if we start soon. The fact is there is no registry right now. As a patient, what do I do today? Ploss: You trust the doctor. 13 IGeL, where doctors now take in 10% more on average for things that are not really medically necessary, and are not approved by doctors and doctors organizations. That may be so, but IGeL services are different entirely from joint replacement, which is a medical... Ploss: necessity. Yes, but arthroplasty, too, is getting to the stage where we must ask ourselves what is medically necessary. Hassenpflug: Yes, the whole issue of indications in arthroplasty is a minefield. And when it comes to quality, the most important question is: When is what measure necessary? It would be easy enough to monitor early results. And with regard to long-term results, I m in favor of the arthroplasty registry. Is that something you would both agree on? When the registry comes on stream, either we use the Certainly, and what do I do if I want a high quality replacement? What advice do you give a patient? Ploss: You must do your research. But patients must have criteria on which to base their choice. That takes either a registry or an external quality assurance system. Hassenpflug: It is very, very difficult for patients because they doesn t know the ins and outs. They don t see the half of it. In arthroplasty, what s crucial is what happens down the road, and no data at all is currently being gathered on that. All they can really do is discuss these things in confidence with the doctor based on, and this may sound almost old-fashioned, a good doctor-patient relationship. And if they have doubts, they would be wise to seek a second or even a third opinion and then make a decision. Gentlemen, it was a pleasure talking to you.

14 Technology 14 SimpleClean TM New masterpiece for spinal surgery A new masterpiece from Link is revolutionizing the market in surgical instruments: SimpleClean, the world s first and only intervertebral disk rongeur, which opens and closes in an instant, thus meeting stringent standards of hygiene. Our SimpleClean rongeur has a patented closing mechanism, which makes it possible to clean and sterilize the open instrument, says Andreas Arnzen, Head of Surgical Instruments at Link. Thanks to this technology, we can guarantee that sterilization can truly provide 100% sterility. The new Link instrument is designed in such a way that the individual components remain connected when open. That way, no part can get lost and the instrument cannot be incorrectly assembled. It also rules out unintentional opening during the operation. Since the beginning of May of this year, Link has been supplying 50 versions of four models. In addition to the unique closing mechanism, the SimpleClean intervertebral disk rongeurs feature the usual high standard of workmanship and easy, sure handling. Furthermore, the titanium/aluminum/nitride coating is non-glare, with good surface hardness, smooth operation thanks to low friction, and thus an even longer service life. Demonstrations can be arranged at: redaktiondirectlink@linkhh.de The gold standard for extensor tendon rupture Innovations drive medical progress. This is why the development of new, pioneering technologies and continuous improvement of the existing product range are a core concern at Link. That said, there are products that simply cannot be improved upon. One example is the Link Stack finger splint. Since the end of the 1970s this has been the undisputed gold standard when it comes to supporting the distal joint of the finger in extension in the case of extensor tendon rupture. In primary patient care, they stabilize so securely that cheaper products from other providers have never had a hope of topping the Link finger splints. Head of the firm Helmut D. Link is proud of this success, saying, Our finger splints may be a marginal product, but they just go to show that engineering skill and excellent workmanship always prevail. Unrivalled market leader: Link Stack finger splint here the Stacktip version, which does not inhibit the patient s sense of touch.

15 Latest studies Female knee achieves no better results The debate surrounding the so-called gender knee has not abated. While it seems to make perfect sense from an anatomic perspective to design femoral knee components specific to the female anatomy, authors on the subject have not been able to demonstrate that female-specific knee implants are any better than other implant designs. Various studies on this particular issue have shown, amongst other things, that preoperative scores in women with a knee implant are worse than in men. Dalury et al. (2009) conducted a multicenter study which found no signifi cant differences between men and women with a gender-specifi c system in relation to improvement in function and pain over a follow-up period of ten years. Emerson and Martinez (2008) compared a group of males with a group of females who had had the Vanguard knee. In the fi rst series, only four sizes were used; in the second, three additional smaller sizes were implanted. The fi nding of the study was that over a short follow-up period of six months there was no difference between the two groups with regard to knee score, pain score and knee fl exion. Clarke and Hentz (2008) looked at radiological parameters with a gender-specifi c and a unisex prosthesis in a female group and ascertained that a compromise had to be made in the implantation technique for women. Finally, MacDonald et al. (2008) studied 3,817 patients with 5,279 primary knee implants of varying design. The authors state that a compromise should often be sought in relation to the intraoperative placement of the femoral component, and that this does not have any negative effect at all on the outcome. The female patients even show a greater improvement in all components of the WOMAC score. Author: Prof. Dr. med. Dr. h.c. Jörg Jerosch, Department of Orthopedics, Traumatology and Sports Medicine, Johanna-Etienne Hospital, Neuss References: 1. Dalury D.F., Mason J.B., Murphy J.A., Adams M.J.: Analysis of the outcome in male and female patients using a unisex total knee replacement system. J Bone and Joint Surgery (Br) 2009; 91-B: Emerson R.H., Martinez J.: Men versus Women. Does Size Matter in Total Knee Arthroplasty? Clin Orthop Relat Res 2008; 466: Clarke H.D., Hentz J.G.: Restoration of Femoral Anatomy in TKA with Unisex and Gender-specifi c Components. Clin Orthop Relat Res 2008; 466: MacDonald S.J., Charron K.D., Bourne R.B., Naudie D.D., McCalden R.W., Rorabeck C.H.: The John Insall Award. Gender-specifi c Total Knee Replacement; Prospectively Collected Clinical Outcomes. Clin Orthop Relat Res 2008; 466: In summary, it must be said that better adaptation of the knee implants to the female anatomy is of defi nite advantage, at least theoretically. However, the clinical studies that have been carried out to date show that the genderspecifi c knee does not hold the prospect of any functional gain for female patients. LINK sled prosthesis still a success after 15 years The unicondylar sled from Link achieves excellent long-term results equal to total knee implants. That is the fi nding of a study conducted by J. Newman and colleagues, which recently appeared in the Journal of Bone and Joint Surgery. In a randomized, prospective comparison of unicompartmental and total knee replacement subjects the Link sled had a survival rate of 89.8% after 15 years. The Bristol Knee Score was just as good as the fi ve-year result and was still better than the corresponding total knee scores. The expert group from the Avon Orthopaedic Centre Bristol also estab-lished that the range of motion in the majority of unicompartmental knees was still 120 degrees after 15 years with no deterioration. Source: Newman J., Pydisetty R.V., Ackroyd C.: Unicompartmental or Total Knee Replacement. J Bone and Joint Surgery (Br) 2009; 91-B:

16 Technology Five million steps in ten weeks Dr. Jan Philippe Kretzer at the Heidelberg Laboratory for Biomechanics and Implant Research uses a knee simulator to determine the rate of wear of knee implants. In an interview with direktlink he tells us why his research is important for implant manufacturers, surgeons and patients alike and gives us the wear test results for the Link Gemini PS SL. 16 directlink: Dr. Kretzer, what does the Laboratory for Biomechanics and Implant Research do? We are a research laboratory first and foremost, answering questions about biomechanics and prostheses that arise in the course of everyday work at the Orthopedic University Hospital Heidelberg. If, for example, a certain knee or hip implant is causing problems, we are in a position to probe the biomechanical causes of prosthesis failure by means of wear tests or strength anal-yses. In our research work, we benefit from the fact that the laboratory is closely involved with day-to-day work in the hospital, including excellent staff communication between the facilities. As a result, our work takes a very practical approach and we can get the results that are relevant for the medical staff. Do you work exclusively with the Orthopedic University Hospital Heidelberg? No, we also get commissions to do tests from the industry as well. Implant manufacturers come to us with product developments or in connection with product approvals, for us to do, for example, a wear test on their hip or knee implants. But we do more than simply hand the implant manufacturer the test result after analysis. We apply our entire engineering and medical know-how to the tests in order to advise the manufacturer comprehensively. It is a service which the implant manufacturers value highly after all, it is very much in their interests to continuously improve the quality of their implants. What exactly is the procedure for wear testing knee implants, for instance? We have a modified knee simulator which can simulate almost all the patterns of motion and locomotion of the human knee. The implants are exposed to standardized loads in this machine over a period of ten weeks. The load is equivalent to that of a person walking at a moderate speed in a straight line. Once a week we pause the simulation and test the poly- Material wear is still one of the most common causes of knee implant failure. Dr. Jan Philippe Kretzer

17 ethylene inlay of the implant for wear. We have different methods at our disposal, for example, gravimetry, which, in simple terms, is a method of quantitative analysis where the polyethylene is weighed to enable us to measure wear at a particular point in time. By the end of the test period, the implants have been exposed to motion and forces equivalent to roughly five million human steps. Thus the test represents an in-vivo joint replacement life of approximately three years. At the beginning of this year you did a wear test on the Link Gemini PS SL. What were the results of the test? For the Gemini PS SL, we measured a mean wear rate of 4.60 mg/million cycles after a test period of ten weeks. This result means that compared with other knee implants from the literature and other knee implants we have tested, the Link implant has a better-than-average rate of wear. You have been conducting wear tests on knee implants since Have you been able to determine in this period whether or not prosthesis quality has improved? Comparing our results from the past five years with results of studies from the 1990s, there s no doubt that quality has changed greatly for the better. The reasons are manifold. For one, manufacturers now pay much closer attention to the prosthesis design. Also, material workmanship has improved, one reason being that the sterilization process used in the manufacture of the polyethylene for implants has been optimized. It goes without saying that all of these factors have a positive effect on the wear rates. The patient stands to benefit most, because excessive material wear is still one of the most common causes of hip and knee implant failure. 17 The Laboratory for Biomechanics and Implant Research is an institute of the Orthopedic University Hospital Heidelberg. It is directed by Professor Dr. med. Volker Ewerbeck (photo left). The laboratory specializes in comprehensive research into implants; conducting, for example, wear tests on hip and knee implants, fatigue life analyses and testing implant fi xation. The institute counts many implant manufacturers among its clients. Dr. Jan Philippe Kretzer is the Technical Director of the laboratory and has been a member of the seven-strong research team since 2004.

18 Technology Gemini SL primary knee New instruments for the minimally invasive Knee replacement has become a routine procedure in Germany. Around 160,000 operations are performed a year, and this fi gure is rising, as are the demands on implants, instruments and surgical technique. Having prosthesis components of anatomic design and offering long-term fi xation are not the only concerns. It is just as important to have an implantation technique that is conducive to effi cient hospital management. 18 Correct alignment of the leg axis, acute awareness of the soft tissue situation and stable primary fixation of the prosthesis are essential to the success of knee replacement. Link has brought together proven and innovative principles of design for the primary replacement of damaged knees. This is exemplified by the Gemini total knee with cemented and cementless components. Gemini total knee arthroplasty is increasingly performed using MIT-K, short for Minimally Invasive Technique Knee. It is very sparing on the patient s muscles, tendons and ligaments and very little blood is lost both during and after the operation. In addition, the newly developed instruments and computer-assisted navigation are proving to be immensely helpful time-saving devices. They allow for more-differentiated procedures, points out Professor Maurilio Marcacci, the Italian orthopedic specialist (see interview on the right). He was instrumental in the development of the navigation software. Highlights from the MIT-K instrument set Alignment instrument for external femoral rotation 3-in-1: This instrument combines three alignment reference lines and also enables rotation to be set precisely in difficult situations: Whiteside s line Transepicondylar axis Dorsal condylar tangent. Femoral cutting block The optimized size of the femoral cutting blocks ensures minimal access without compromising the quality of the resections.

19 The computer-assisted navigation system BLUIGS, an Orthokey product, enables the surgeon to align the leg axes more precisely and position the resection guides more exactly. The outcome makes for greater patient satisfaction because patients can often be discharged earlier and subsequently undergo fewer revisions. In addition, says Marcacci, the need for fewer instruments over the course of surgery makes the surgeon s and surgical team s job easier. At the same time, the cost of sterilization is lower for the procedure. The instrument set has just been upgraded by Link. Thanks to the navigation system the incision is smaller and the procedure less invasive Professor Maurilio Marcacci is Direttore del Laboratorio di Biomeccanica at the University of Bologna. The 61-year-old is a specialist in minimally invasive surgery and has many years of experience in the use of computer-assisted navigation in knee and hip operations. directlink: Will the navigation system completely replace the conventional instrument set one day? If so, how many years will it take? The navigation system can already do more than the conventional instrument set, because it is capable of things which would be difficult to achieve by conventional methods and means. How is the navigation system different from conventional instruments? From a clinical point of view, it must be stressed that the navigation system facilitates much better kinematic and morphological assessment of the patient than conventional instruments. This new technique enhances the clinical outcome by allowing for more-differentiated procedures, making for greater patient satisfaction. Navigation equipment ensures that the incision is smaller and the procedure less invasive. There is no need to use intramedullary guides for resection. Naturally, these benefits shorten the patient s hospital stay and thus reduce the cost of treatment. The ergonomic and economic merits of the modified instrument set are aspects of the navigation-assisted technique which should not be underappreciated either. Fewer in struments over the course of surgery makes the surgeon s and surgical team s job easier. At the same time, the cost of sterilization is lower for the procedure. Is it true that surgery takes longer if navigation is used? Absolutely not. Once you are familiar with it, surgery takes the same length of time. If the surgeon is experienced in the navigation-assisted technique, the operation may even be shorter. Is navigation equipment better suited to hip operations or knee operations? Computerassisted surgery is mainly used on the knee. But the advantages for hip surgery are not to be sniffed at, when the access is smaller and the surgeon s view of the anatomy is restricted. Also, in cases like this, and with similar surgery times, lots of specific information on the patient can be gathered using the navigation equipment and the relevant surgical instruments, which leads to better clinical outcomes and reduced hospital costs. 19

20 Practice Taking the modular principle to the next level Revision rates in knee arthroplasty continue to rise disproportionately. Consequently, more and more patients are exposed to greater risk of complications. Professor Dr. Christoph Ulrich, Director and Head of Orthopedics and Traumatology at Klinik am Eichert in Göppingen. 20 directlink: Professor Dr. Ulrich, according to the statistics, the rate of knee revision is rising disproportionately to primary arthroplasty. What is the situation in your department? Our experience is somewhat different. In our department, the revision rate in knee arthroplasty has been relatively constant for years: We perform secondary operations in approximately 10% of cases of primary implantation a figure which, incidentally, is much higher than in hip surgery. What types of revision are there in knee arthroplasty? We differentiate between soft-tissue procedures and implant revisions. In addition, it is very common for pain to arise in the patella area during rehabilitation, for which there are many reasons. A lot of time is now being allocated at many orthopedic conferences to the problems associated with soft tissue and patella and, despite very careful surgical techniques, there remain a number of stubborn problems experienced by all hospitals. Navigation systems, by the way, do not diminish these difficulties either, and recent publications have proven this. Example of total femur replacement with the Link push-through stem What is the percentage of patients who have undergone multiple prior operations in your department and how do you deal with the greater risk of infection in these patients? The percentage of patients who have undergone multiple prior operations in our department is approximately 5%. To prevent infections we use, for example, a soft-tissue-sparing surgical technique. In addition, the perioperative administration of antibiotics is used to minimize the risk of infection. The use of bone cement which contains antibiotics is another means. What are the criteria by which you choose the revision implants? We base our decision on a number of criteria, including, for instance, non-critical implantation management and high prosthesis fixation stability. We must also take account of the fact that extensive bone resection is not required. Other parameters which have a bearing on the choice of suitable revision implant are modularity, allowing for possible further revisions, through to the push-through prosthesis. The number of periprosthetic fractures has been on the increase in recent years. How do you treat these cases? When deciding on a particular surgical technique it is important first and foremost to as-

21 Our last resort in the treatment of periprosthetic comminuted fractures is the push-through prosthesis, which allows for further revisions thanks to its modular design. Prof. Dr. Christoph Ulrich Klinik am Eichert, Göppingen, Germany is a hospital providing acute care (on the second-highest tier of the German hospital system) with a total of 19 departments, ten centers and three institutes. The hospital has more than 800 beds and is the academic teaching hospital for the University of Ulm. Prof. Dr. med. Christoph Ulrich is Director and Head of Orthopedics and Traumatology. The department specializes in the surgical and conservative treatment of trauma cases and conditions resulting from trauma, including rehabilitation and restorative surgery. Other core competences include arthroplasty, spinal surgery and geriatric traumatology. The hospital also offers outpatient services in arthroscopy and foot and hand surgery. Eleven consultants work in the department. certain whether the prosthesis is loose or not. In the case of fixed prostheses, plate osteosynthesis using special revision plates and the option of additional cerclage wires is still indicated. If the prosthesis is loose, we consider the use of a cementless proximal femur replacement system such as the Link MP system after removal of the loose prosthesis to be our first choice. Its modularity and the possibility of adjusting length during the operation without causing bone stress make this method second to none. Our last resort in the treatment of periprosthetic comminuted fractures in conjunction with poor bone quality and an over-long implant is the push-through prosthesis, which allows for further revisions both distal and proximal thanks to its modular design. How do you proceed if knee replacement is out of the question? After multiple revisions, arthrodesis is only possible if we settle for considerable leg shortening. So far we have only had to perform arthrodesis in two cases otherwise we tend to opt for the implantation of a rotating knee implant with a long modular tibial stem in conjunction with a proximal push-through stem. How do you think revision arthroplasty will de velop in the future? On the basis of existing implants. Future revision arthroplasty must be geared towards modularity and build on this principle to allow for further revisions at any time. With the rising number of secondary operations the potential for complications will also increase exponentially. 21

22 Practice 22 Tricky decision Hip revisions are very challenging for surgeons. Choosing a suitable fi xation system is important to the success of a secondary operation. But the question is cemented or cementless hip revision stems, and here to answer that is Dr. med. Wolfgang Klauser, Deputy Medical Director of the Endo-Klinik in Hamburg. directlink: Dr. Klauser, when do you use cemented hip revision stems and when cementless? I cannot give a one-size-fits-all answer. In general, my decision hinges on the extent of bone loss and the geometry of the femur. Biological factors also come into play; for instance, the patient s general state of health, additional underlying illnesses and ability to apply some pressure to the operated joint in the short and long term, that is, anything from several weeks to months. In addition, the decision is informed by the technique I wish to use; whether, for example, I want to pack the shaft with homologous allografts using the impaction grafting technique. Ultimately, when using cementless stems, I decide based on the form of the remaining bone and the bone quality. Bone loss in these cases should not have reached the femoral isthmus. What are the pros and cons of the two fixation systems? The main advantage of cementless stems is modularity. It allows me to respond much better to the conditions in hand during the operation, such as the need to lengthen the leg. However, revisions potentially entail the removal of the prostheses. But only in the event of infection. With other revisions, for example, recurrent luxations, it is possible to keep the procedure relatively minor by replacing modular sections of the prosthesis. In our experience of such prostheses, the bone is remodeled from distal to proximal and can take a prolonged period of time, that is, two or three years. Interestingly, we observe different kinds of regeneration: The thickening of cortical structures as in axial regeneration, and the regeneration or, rather, recalcification of osteolyses as in circular regeneration. When using homologous bone to fill the shaft and subsequently embedding a femoral component in cement, we apply the principles of impaction grafting. The structure is such that at least in some cases it is possible to choose a shorter implant in the event of revision. However, the complications of infection are just as serious as with cementless stems. Which hip systems does the Endo-Klinik work with? As far as cementless fixation is concerned, we like to work with the modular MP revision stem. I have been using it for years and my colleagues now also have a high opinion of it. As re-

23 gards cemented revision components, we have a large number of anatomically formed revision stems of various lengths, including curved ones. What are the special technical and medical merits of these systems? Aside from modularity, which I have already mentioned, the MP stem, at least in my view, affords a certain degree of user-friendliness. At an angle of three degrees, for example, it is much easier to introduce it into the femoral medullary canal. But it is also important to recognize the limitations of this implant. As I see it, it s not purely about distal fixation; rather, one should try to fix the stem in the femur as far toward proximal as possible because you then have the option of going shorter in the event of a revision. The advantages of the cemented long stems and stem attachments is being able to use tried-and-tested prosthesis designs, in some cases even primary prostheses, which we know will last the distance. What clinical results have you found for the prosthesis systems you use? We have had good results with the MP stem in the eight- to twelve-year range, both in terms of the life of the stem and the clinical outcomes. In addition, more than 85% of cases showed good bone regeneration. I think the results of stem synthesis are similar. I don t have the latest results in our hospital, but we know from a number of studies that this technique is effective. 23 New home for Endo-Klinik On 14 May 2009 the Endo-Klinik in Hamburg opened its extension adjacent to the existing main building. The modern special clinic, which took two years to build at a cost of 60 million euros, has an intermediate care facility, an intensive care ward and eight operating theaters, including a large 213 sq. m. theater with four tables, and meets the highest medical standards. After the move, we aim to expand our arthroplasty core competence by up to 20%. We also plan to expand the area of sports orthopedics, sports traumatology and rheumatological orthopedics, says Dr. Thorsten Gehrke, Medical Director of the Endo-Klinik. The plan is to merge the extension with the old building in Between now and then the latter will be renovated in a project costing 28 million euros.

24 Practice 24 No compromise Görlitz-born Dr. Uwe-Karsten Schöbel has been Head of Traumatology at the municipal hospital in his native town since He knows many of his patients personally, one more reason for the head of department to settle for nothing less than top quality when choosing joint replacement prostheses. Somehow I got stuck in Görlitz, says Dr. Uwe- Karsten Schöbel and laughs, as he knows all too well that he could wish for nothing better. Until he went to Jena to study, the orthopedist and traumatologist had spent his entire life in his home town. Here, on the easternmost edge of Germany, is where he went to school, started a family and established his career. There was never any reason to work anywhere else, says the father of three and husband to a GP in private practice. I have it all here, in both my professional and private life. The far East Görlitz is the most easterly city in the Federal Republic of Germany. After the Second World War, it was split in two by the Allies, leaving half the town on either side of the German-Polish border (the Polish town is called Zgorzelec). Around 58,000 people currently live on the Saxon side. Görlitz Municipal Hospital complex consists of 16 clinics, two institutes, two subsidiary companies and various medical centers, making it the main hospital in East Saxony and, with 1,100 employees, the second-larger employer in the region. It has 585 beds, 39 of them for trauma surgery, caring for around 22,000 inpatients and 50,000 outpatients a year. Around two and a half years ago Schöbel be came Head of Traumatology at Görlitz Municipal Hospital. In 1981, right after graduating, he got a job there and since then has climbed all the steps of the career ladder from junior doctor to head of department. Schöbel s department treats injuries ranging from scratches to lifethreatening multiple injuries. Another specialization is arthroplasty. Surgeons at Görlitz hospital implant around 60 knee and 120 hip prostheses a year. Quality is the absolute priority when it comes to choosing implants. By arrangement with administration

25 at all levels, we decided early on to go for brand products and renowned manufacturers. That accommodates my work very well, for I am the person who is ultimately responsible to the patient, says Schöbel. This carries all the more weight because the Görlitz surgeon knows many of his patients well, some of them very well indeed. Just last year his father needed a hip replacement and asked him to perform the procedure. Schöbel was unenthusiastic at first. There are more pleasant tasks for a surgeon than operating on one s own father. I was reluctant, and only said to him just before the operation that I would implant the prosthesis, he tells us. It was the right decision, or at least my father seemed to be very satisfied after the operation. Not long after, the 78-yearold Gerhard Schöbel had recovered enough to take up gardening again. The Link SPII Lubinus hip system gives him the mobility he needs to pursue his hobby. The Görlitz Traumatology department has been using the hip prosthesis from Link since the end of Our previous industry partner replaced its traditional hip prosthesis with a new model, but as we were not thrilled with the new prosthesis, we looked around for alternatives. The SPII won through in the end, A life in Görlitz Dr. Uwe-Karsten Schöbel originally wanted to take over his father s privately run workshop and become an orthopedic shoemaker. His father advised him against it, however, as he saw no future for private enterprise in the GDR. In February 1972, when Schöbel was in year 10 of grammar school, the SED Politburo nationalized all semi-national companies. While private workshops escaped the wave of expropriation, Schöbel s father was convinced it would not be long before they were hit. So he advised his son to take a different career path. Uwe-Karsten Schöbel decided on medicine. In 1981 he became a junior doctor in Traumatology at Görlitz Municipal Hospital and six years later rose to the position of consultant. In 1993 he was appointed senior doctor and in 2006 Head of Traumatology. simply because it achieved the best results, recalls Schöbel of how the partnership came about. Aside from the SPII hip system, the Endo-Model rotating knee, the C.F.P. hip system with BetaCup ceramic cup and the shoulder instrument set from Link are now integral to the hospital Over the years, Schöbel came to value the partnership with the company more and more: Link s strength lies not just in its outstanding product quality; I find the firm s customer care and service compelling too. The Link Toolbox, for example, is a first-class idea. The implants and instruments always arrive punctually and the boxes are so neatly packed that we could start straight away. That s no mean feat. He also says that ease of handling of prostheses and instrument sets is an important advantage especially since the theater nurses at the clinic work in other surgical areas as well as Traumatology. When a nurse only assists with three or four Traumatology operations a year, he or she must immediately get to grips with the instrument set. There s no room for trial and error, explains Schöbel. For the same reason, he and his staff must be able to depend on the manufacturer not to constantly change its prosthesis models. For Schöbel, consistency and reliability are indispensable, in technical respects too. 25

26 Forum Great response to survey In our anniversary issue 10/2008 we did a survey asking our readers to give their opinion on the newly designed directlink. 26 We received much positive feedback, which reassures us that we are going the right direction. But we also received interesting suggestions on how to improve our magazine, which we have already taken up in this issue. directlink is no different from our products in that we always aim to deliver first-class quality. These readers have won an Apple ipod as part of our survey (l. to r.): Dr. med F. Michael Hocke, Head of Surgery at Dill Clinics in Dillenburg-Herborn Dr. med. Herbert Hessler, Senior Doctor at Celle General Hospital Dr. med. Stefan Gaum, Senior Doctor at Reutlingen Clinic Thanks to all who took part! Publication details Publisher: Waldemar Link GmbH & Co. KG Helmut D. Link Editing (responsible): Heike Urbschat, Tel.: +49 (0) , redaktiondirectlink@linkhh.de Realization/Production: schmitz-komm.de Medien GmbH Hamburg Consulting: Thomas Schmitz Text: Dr. Holger Iburg, Stephan Siebenbaum Layout: Michael Weilandt Project management: André Nacke Photos: Sven Brüggemann (p 22), Endo-Klinik (p 23), LINK (pp 2, 3, 4, 5, 14, 16, 17, 18, 19, 20, 26, 27, 28), Maja Metz (Title, pp 8-13), Pressmaster/fotolia.com (p 7), Royal National Orthopaedic Hospital Stanmore (p 6), Carmen Steiner/fotolia.com (p 5), Alexander Yakovlev/ fotolia.com (p 15), Jürgen Zeidler (p 24, 25) Litho: Dunz-Wolff GmbH Hamburg Printing: WALDEMAR LINK GmbH & Co. KG Barkhausenweg Hamburg, Germany Tel.: Fax: redaktiondirectlink@linkhh.de

27 Link Toolbox Link s implant service supplies prostheses and the instrument set, ready for sterilization, in time for surgery. After the operation, the blue Toolbox goes back to the Hamburg manufacturer. In this photo, a qualified member of staff checks that the instruments are all there and are functioning correctly.

28 Disinfection machines As soon as the implants leave production, they must go through a sophisticated hygiene process. Link has four powerful cleaning and disinfection machines built by Miele, which uniformly rinse and clean the products with ultra-pure water.