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EditorialInterviewFocus on QualityAssuranceCeraNews 1/2012Dear Reader,Dieter Burkhardt,Director Salesand MarketingJoint Registry data summarize important and neutralfindings about the success rates of THA andTKA. Even though we keep seeing many countrieswithout a registry, there are several initiatives to setup regional registries.After many years of discussion, the German arthroplastyregistry will finally be set up in 2012. It is animportant, but by no means the only initiative aimedat making arthroplasty even better and safer. Thisis because, in view of the constantly rising numbersof cases, we cannot be satisfied even with successrates way above 90 percent. The small remainingpercentage of problem cases means that a sizeablenumber of patients are affected here and now.Reducing this number is the most important goalof all our efforts to achieve even higher quality andimplant safety. It means we must look at the complexprocess of arthroplasty as a whole. The trainingof surgeons and surgical personnel plays a crucialrole here. The Arbeitsgemeinschaft Endoprothetik(Arthroplasty Association, AE) has developed andput into practice a number of exemplary concepts inthis area. AE chairman Klaus-Peter Günther explainswhat this involves – among other things – in theinterview opposite.These initiatives have one thing in common: theyare based on the close and trusting collaboration ofdoctors and implant industry. The highest possiblequality of arthroplasty is our common concern."Sharing of the best practice": This is the mottoof the 14 th BIOLOX ® symposium – Bearing SurfaceOptions in Total Joint Replacement – The Expertsprovide the Evidence. This one and half-day eventsponsored by CeramTec is being held in conjunctionwith the Current Concepts in Joint Replacement(CCJR) – Spring meeting at the ARIA at City-Center in Las Vegas, Nevada, USA, May 19–20.The opportunity to attend both events will realize aunique learning experience. I’m looking forward towelcome you in Las Vergas.Sincerely yours,Dieter Burkhardt* AE – www.ae-germany.comKlaus-Peter Günther, MD, PhD, holds theChair for Orthopaedics in the Carl GustavCarus Medical School at Dresden TechnicalUniversity and is Medical Director of theOrthopaedic Clinic and Outpatient Centerat the University Hospital. As Chairmanof the Portal Steering Committee, he is amember of the EFORT Executive Committee.Since 2011, he has been President ofthe German Arbeitsgemeinschaft Endoprothetik(Arthroplasty Asso ciation, AE) * . Hisscientific work focuses on issues relatedto clinical efficiency and quality.Recent media coverage gives the impression thatarthroplasty is a field dominated by problems. Whatcould have given rise to such a lopsided public perception?Expectations have been raised which cannot alwaysbe met. For example, in their marketing, someimplant manufacturers give unrealistic depictionsof what postoperative activities will be possible.Surgeons in Germany are also confronted with acompetitive environment and some try to positionthemselves with "major successes" from procedureswhich have only recently been introduced. Finally,many patients tend to have unrealistic expectations.They assume that there are procedures whichpermit unlimited demands to be placed on theimplants with maximum safety and a minimal risk.However, even with the most cautious approach,the risk of an early revision after arthroplasty is 2to 4%. Another factor is the media, which occasionallyseize on isolated cases with poor outcomesand depict them in a sensationalist manner. Becausethere is no completely safe procedure in medicine,undue expectations turn the overall great successof arthroplasty into something quite the opposite inthe eyes of the public.Let's take a look at professional training. Does it doenough in its current form to keep arthroplasty at ahigh level and further reduce the incidence of complications?Germany does have regulations for specialty trainingas part of the continuing medical education,thanks to which we have a robust process andadequate general conditions, such as those stipulatingthe number of surgeries which a prospectivespecialist must have performed as a prerequisite forformal qualification as an orthopaedic and traumasurgeon. However, more and more hospitals are2
What is is the motive behind the latter?Klaus-Peter Günther,MD, PhDBoth physicians and industry must learn how tohandle incidents effectively. The aviation industry,for example, is somewhat ahead of us in thisrespect. They regard the incident primarily as anopportunity to improve the process. In the field ofarthroplasty, joint initiatives have been launched bymanufacturers, scientists, and surgeons. It is, afterall, essential for incidents to be recorded in a systematicmanner, which is why standardized requirementsare necessary. Physicians are often unsurehow to handle implant retrievals. While there arelegal requirements, physicians are often not sufficientlyaware of them.pulling out of advanced training because they donot get paid for it. As a result, something which issensibly regulated in theory is getting ever more difficultto implement in practice.How do you see the situation with regard to continuingeducation itself?The problem is ensuring consistently high qualityand creating appropriate general conditions. Weshould bear in mind that colleagues performingarthroplasties have to meet certain conditions. Itshould be ensured that they are constantly undergoingcontinuing education and that this is monitoredregularly. That is also the goal of the EndoCert initiative** for the establishment of certified arthroplastycenters. It would be a condition of certification thatthe clinic conducts continuing medical educationbased on structured plans and that its staff demonstrablymake regular use of the continuing medicaleducation offerings.Continuing medical education of this type is offeredin German-speaking countries by the AE, of whichyou are President. What is the goal?The primary goal of the AE is to ensure high qualitytraining and continuing medical education inthe field of arthroplasty. For this purpose, it offersa structured system of courses for physicians andoperating room personnel. In so doing, the AEdiffers significantly from other specialist societieswhich generally either focus on a single joint, suchas the hip societies, or on specific procedures, suchas the societies for arthroscopy. Our scope extendsfrom joint preserving procedures to complex revision,and includes all joints. Our other quality assuranceactivities include involvement in the Germanarthroplasty registry and EndoCert, as well as ourown initiative aimed at optimizing failure analysis.Should surgeons be obligated to undergo implantspecifictraining, the key idea being "no train, nouse"?A new product should only be used if physiciansand OR personnel have received the applicabletraining. This is a clear criterion for certificationunder the EndoCert initiative we talked aboutpreviously.What role can an arthroplasty registry play?Arthroplasty registries are of no help when analyzingindividual incidents. However, they can provideearly indications of the failure of one or more contributingfactors – e.g., a faulty implant or an applicationmistake – if problems occur frequently. Fortunately,an arthroplasty registry is now also beingestablished in Germany.What is your experience with the increasing timepressure in the German healthcare system, aboutwhich physicians are complaining? Does this haveany impacts on clinical practice?There is already a high degree of time pressureassociated with the introduction of new implants,not only from the manufacturer, but also on thepart of physicians. While the introduction of newimplants satisfies formal conditions, I would like tosee a stepwise process required for substantiallychanged or novel implants. This should start withtesting in selected arthroplasty centers, and onlythereafter should the implants be released for themarket. Outside the field of arthroplasty, we arealso facing increasing problems, with significantlyhigher strain on everyone involved to find the timefor the necessary internal and external continuingmedical education programs.** EndoCert – See also interview withMittelmeier, MD, PhD, on page 8CeraNews 1/20123
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EditorialInterviewFocus on QualityAssuranceCeraNews 1/2012Dear Reader,Dieter Burkhardt,Director Salesand MarketingJoint Registry data summarize important and neutralfindings about the success rates of THA andTKA. Even though we keep seeing many countrieswithout a registry, there are several initiatives to setup regional registries.After many years of discussion, the German arthroplastyregistry will finally be set up in 2012. It is animportant, but by no means the only initiative aimedat making arthroplasty even better and safer. Thisis because, in view of the constantly rising numbersof cases, we cannot be satisfied even with successrates way above 90 percent. The small remainingpercentage of problem cases means that a sizeablenumber of patients are affected here and now.Reducing this number is the most important goalof all our efforts to achieve even higher quality andimplant safety. It means we must look at the complexprocess of arthroplasty as a whole. The trainingof surgeons and surgical personnel plays a crucialrole here. The Arbeitsgemeinschaft Endoprothetik(Arthroplasty Association, AE) has developed andput into practice a number of exemplary concepts inthis area. AE chairman Klaus-Peter Günther explainswhat this involves – among other things – in theinterview opposite.These initiatives have one thing in common: theyare based on the close and trusting collaboration ofdoctors and implant industry. The highest possiblequality of arthroplasty is our common concern."Sharing of the best practice": This is the mottoof the 14 th BIOLOX ® symposium – Bearing SurfaceOptions in Total Joint Replacement – The Expertsprovide the Evidence. This one and half-day eventsponsored by <strong>CeramTec</strong> is being held in conjunctionwith the Current Concepts in Joint Replacement(CCJR) – Spring meeting at the ARIA at City-Center in Las Vegas, Nevada, USA, May 19–20.The opportunity to attend both events will realize aunique learning experience. I’m looking forward towelcome you in Las Vergas.Sincerely yours,Dieter Burkhardt* AE – www.ae-germany.comKlaus-Peter Günther, MD, PhD, holds theChair for Orthopaedics in the Carl GustavCarus Medical School at Dresden TechnicalUniversity and is Medical Director of theOrthopaedic Clinic and Outpatient Centerat the University Hospital. As Chairmanof the Portal Steering Committee, he is amember of the EFORT Executive Committee.Since 2011, he has been President ofthe German Arbeitsgemeinschaft Endoprothetik(Arthroplasty Asso ciation, AE) * . Hisscientific work focuses on issues relatedto clinical efficiency and quality.Recent media coverage gives the impression thatarthroplasty is a field dominated by problems. Whatcould have given rise to such a lopsided public perception?Expectations have been raised which cannot alwaysbe met. For example, in their marketing, someimplant manufacturers give unrealistic depictionsof what postoperative activities will be possible.Surgeons in Germany are also confronted with acompetitive environment and some try to positionthemselves with "major successes" from procedureswhich have only recently been introduced. Finally,many patients tend to have unrealistic expectations.They assume that there are procedures whichpermit unlimited demands to be placed on theimplants with maximum safety and a minimal risk.However, even with the most cautious approach,the risk of an early revision after arthroplasty is 2to 4%. Another factor is the media, which occasionallyseize on isolated cases with poor outcomesand depict them in a sensationalist manner. Becausethere is no completely safe procedure in medicine,undue expectations turn the overall great successof arthroplasty into something quite the opposite inthe eyes of the public.Let's take a look at professional training. Does it doenough in its current form to keep arthroplasty at ahigh level and further reduce the incidence of complications?Germany does have regulations for specialty trainingas part of the continuing medical education,thanks to which we have a robust process andadequate general conditions, such as those stipulatingthe number of surgeries which a prospectivespecialist must have performed as a prerequisite forformal qualification as an orthopaedic and traumasurgeon. However, more and more hospitals are2
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