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Register als Werkzeug für mehr Endoprothesensicherheit

Erfahrungen aus anderen Ländern und dem Aufbau des Endoprothesenregisters Deutschland

Registries as a tool for optimizing safety of endoprostheses

Experiences from other countries and the setup of the German arthroplasty register

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Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz Aims and scope

Zusammenfassung

Bis heute fehlt eine strukturierte Langzeitdokumentation der Ergebnisse von Hüft- und Knieendoprothesenoperationen in Deutschland. Im vorliegenden Beitrag werden die Zielsetzung, Struktur und Datenflüsse des neu aufgebauten Endoprothesenregisters Deutschland (EPRD) beschrieben. Das EPRD ist als gemeinnützige GmbH und 100%ige Tochter der wissenschaftlichen Fachgesellschaft Deutsche Gesellschaft für Orthopädie und orthopädische Chirurgie (DGOOC) ausschließlich wissenschaftlichen Grundsätzen verpflichtet. Der bürokratische Aufwand wird durch Nutzung von Abrechnungsdaten und durch die Barcode-Identifikation der Prothesen anhand einer neu entwickelten Implantatdatenbank so gering wie möglich gehalten. Das EPRD dokumentiert die Standzeit der Kunstgelenke vom Einbau bis zum ggf. notwendigen Wechsel. Die Ursachen für den Misserfolg einer Implantation werden aufgeschlüsselt und zeigen, ob die verwendeten Implantate, das operative Vorgehen oder auch patientenspezifische Merkmale für eine erneute Operation verantwortlich sind. Die Daten bilden eine entscheidende Grundlage für die Versorgungsforschung im Bereich der Endoprothetik und können nach den Erfahrungen bereits existierender Register im Ausland wesentlich dazu beitragen, die Revisionsfrequenz von Endoprothesen zu verringern. Unter Beachtung aufwendiger Datenschutzvorgaben ist bei Serienschäden eine Re-Identifikation der betroffenen Patienten möglich.

Abstract

There has previously been no structured long-term documentation of the results of hip and knee prosthesis operations in Germany. This article presents the objectives, structure and data flow of the newly established German arthroplasty registry (EPRD). The EPRD is run as a subdivision of the German Society for Orthopedics and Orthopedic Surgery (Deutsche Gesellschaft für Orthopädie und orthopädische Chirurgie, DGOOC). It is dedicated to scientific principles and guarantees independency and immediate feedback to surgeons. The cooperation between insurance funds, hospitals, industry and scientific society is the key to success. Additional data acquisition and bureaucratic formalities are limited to a minimum and in particular there is no use of paper. Involving the health insurance funds provides access to relevant routine data. The implant documentation is facilitated by means of an implant library and barcode scanning in the operating room. The EPRD documents the survival of implants including the reasons for revision. Although the highest level of patient data protection is guaranteed, individual patients can be identified in case of implant recalls.

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Notes

  1. „Burden of revision“: Quotient zwischen Revisionsoperationen und der Summe aus Revisionsoperationen und Primärimplantationen.

  2. Diese Ergebnisse wurden im Juli 1997 in einem orthopädischen Journal veröffentlicht [13].

  3. Finnland: 4,06 Revisionen pro 100 Komponentenjahre; Schweden: 0,72 Revisionen pro 100 Komponentenjahre.

Literatur

  1. Lidgren L (1998) The bone and joint decade 2000–2010 for prevention and treatment of musculo-skeletal disorders. Lund, Sweden, April 17–18, 1998. Proceedings. Acta Orthop Scand Suppl 281:1–86

    Google Scholar 

  2. Fuchs J, Rabenberg M, Scheidt-Nave C (2013) Prevalence of selected musculoskeletal conditions in Germany: results of the German Health Interview and Examination Survey for Adults (DEGS 1). Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz 56(5–6):678–686

  3. Qualitätsreport (2011) Göttingen: AQUA – Institut für angewandte Qualitätsförderung und Forschung im Gesundheitswesen GmbH

  4. Moran CG, Horton TC (2000) Total knee replacement: the joint of the decade. A successful operation, for which there's a large unmet need. BMJ 320(7238):820

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  5. Learmonth ID, Young C, Rorabeck C (2007) The operation of the century: total hip replacement. Lancet 370(9597):1508–1519

    Article  PubMed  Google Scholar 

  6. Labek G, Thaler M, Janda W, Agreiter M, Stockl B (2011) Revision rates after total joint replacement: cumulative results from worldwide joint register datasets. J Bone Joint Surg Br 93(3):293–297

    Article  CAS  PubMed  Google Scholar 

  7. Kurtz S, Mowat F, Ong K, Chan N, Lau E, Halpern M (2005) Prevalence of primary and revision total hip and knee arthroplasty in the United States from 1990 through 2002. J Bone Joint Surg Am 87(7):1487–1497

    Article  PubMed  Google Scholar 

  8. Herberts P, Malchau H (2000) Long-term registration has improved the quality of hip replacement: a review of the Swedish THR Register comparing 160,000 cases. Acta Orthop Scand 71(2):111–121

    Article  CAS  PubMed  Google Scholar 

  9. Herberts P, Malchau H (1997) How outcome studies have changed total hip arthroplasty practices in Sweden. Clin Orthop Relat Res (344):44–60

  10. Maloney WJ (2001) National Joint Replacement Registries: has the time come? J Bone Joint Surg Am 83-A(10):1582–1585

    CAS  PubMed  Google Scholar 

  11. Riehmann M (2005) Regulatory measures for implementing new medical devices. Recalling Boneloc. Dan Med Bull 52(1):11–17

    PubMed  Google Scholar 

  12. 3M Capital Hip System Steering Group (2001) An Investigation of the Performance of the 3M™ Capital™ Hip System. ISBN 0 902166 48 4.35–43 Lincoln's Inn Fields, London WC2A 3PE: The Royal College of Surgeons of England, Clinical Effectiveness Unit

  13. Massoud SN, Hunter JB, Holdsworth BJ, Wallace WA, Juliusson R (1997) Early femoral loosening in one design of cemented hip replacement. J Bone Joint Surg Br 79(4):603–608

    Article  CAS  PubMed  Google Scholar 

  14. The Royal College of Surgeons Clinical Effectiveness Unit, The NJR Centre H, The NJR Editorial Board for the 1st Annual Report. National Joint Registry for England and Wales. 1st Annual Report | September 2004. Peoplebuilding 2, Peoplebuilding Estate, Maylands Avenue, Hemel Hempstead HP2 4NW, England: National Joint Registry for England and Wales; 2004 Sep 15

  15. Roy N, Hossain S, Ayeko C, McGee HM, Elsworth CF, Jacobs LG (2002) 3M Capital hip arthroplasty: 3–8-year follow-up of 208 primary hip replacements. Acta Orthop Scand 73(4):400–402

    Article  PubMed  Google Scholar 

  16. McMinn Centre (2005) Northern Lights Debate ASR vs BHR – Helsinki

  17. MHRA (2006) Minutes of the Committee on the Safety of Devices Meeting: 23 March 2006. Report No.: PS 19.4.06–02

  18. Cohen D (2011) Out of joint: the story of the ASR. BMJ 342:d2905

  19. Karrholm J (2010) The Swedish Hip Arthroplasty Register (www.shpr.se). Acta Orthop 81(1):3–4

    Article  PubMed Central  PubMed  Google Scholar 

  20. Knutson K, Robertsson O (2010) The Swedish Knee Arthroplasty Register (www.knee.se). Acta Orthop 81(1):5–7

    Google Scholar 

  21. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report (2010). Adelaide: Australian Orthopaedic Association. https://aoanjrr.dmac.adelaide.edu.au/de/annual-reports-2010. Zugegriffen: 13 März 2013

  22. Canadian Joint Replacement Registry (CJRR) Bulletin (2002): Surgical and Orthopaedic Implant Information for Total Hip and Total Knee Replacement Procedures Performed in Canada, May 2001–March 2002.Canadian Institute for Health Information (CIHI), Toronto

  23. Capozzi JD, Rhodes R (2010) Examining the ethical implications of an orthopaedic joint registry. J Bone Joint Surg Am 92(5):1330–1333

    Article  PubMed  Google Scholar 

  24. Muller D, Augustin M, Banik N, Baumann W, Bestehorn K, Kieschke J, Lefering R, Maier B, Mathis S, Rustenbach SJ, Sauerland S, Semler SC, Stausberg J, Sturm H, Unger C, Neugebauer EA (2010) Memorandum registry for health services research. Gesundheitswesen 72(11):824–839

    Article  CAS  PubMed  Google Scholar 

  25. Kolling C, Simmen BR, Labek G, Goldhahn J (2007) Key factors for a successful National Arthroplasty Register. J Bone Joint Surg Br 89(12):1567–1573

    Article  CAS  PubMed  Google Scholar 

  26. Bourne RB (2008) The Canadian Joint Replacement Registry: Gaining Momentum. The Canadian Orthopaedic Association

  27. National Joint Registry for England and Wales (2013) 10th Annual Report 2013. Hernel Hempstead, Hertfordshire, UK: NJR Centre. Report No.: 10

  28. Serra-Sutton V, Allepuz A, Espallargues M, Labek G, Pons JM (2009) Arthroplasty registers: a review of international experiences. Int J Technol Assess Health Care 25(1):63–72

    Article  PubMed  Google Scholar 

  29. Bourne RB (1999) The planning and implementation of the Canadian Joint Replacement Registry. Bull Hosp Jt Dis 58(3):128–132

    CAS  PubMed  Google Scholar 

  30. Rothwell AG (1999) Development of the New Zealand Joint Register. Bull Hosp Jt Dis 58(3):148–160

    CAS  PubMed  Google Scholar 

  31. Liebs TR, Splietker F, Hassenpflug J (2013) Similarities and differences in reports of national arthroplasty registries. 2nd International Congress of Arthroplasty Registries, Stratford-upon-Avon

  32. Troelsen A, Malchau E, Sillesen N, Malchau H (2013) A review of current fixation use and registry outcomes in total hip arthroplasty: the uncemented paradox. Clin Orthop Relat Res 471(7):2052–2059

    Article  PubMed Central  PubMed  Google Scholar 

  33. Pitto RP, Lang I, Kienapfel H, Willert HG (2002) The German Arthroplasty Register. Acta Orthop Scand Suppl 73(305):30–33

    Article  CAS  PubMed  Google Scholar 

  34. Heinz BC, von Mallek D (2005) Vorkommnisse bei Hüft- und Knieendoprothesen. Orthopäde 34:47–54

    Article  CAS  PubMed  Google Scholar 

  35. Labek G, Todorov S, Lubbeke-Wolff A, Haderer B, Krivanek S (2012) Revision rates in journal publications on joint prostheses with noticeably high failure rates in register data sets. Orthopäde 41(10):853–859

    Article  CAS  PubMed  Google Scholar 

  36. Sadoghi P, Thaler M, Janda W, Hubl M, Leithner A, Labek G (2013) Comparative pooled survival and revision rate of austin-moore hip arthroplasty in published literature and arthroplasty register data. J Arthroplasty 28(8):1349–1353

    Article  PubMed  Google Scholar 

  37. Wegscheider K (2004) Medical registries. Benefits and limitations. Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz 47(5):416–421

    Article  CAS  Google Scholar 

  38. Schuh R, Neumann D, Rauf R, Hofstaetter J, Boehler N, Labek G (2012) Revision rate of Birmingham Hip Resurfacing arthroplasty: comparison of published literature and arthroplasty register data. Int Orthop 36(7):1349–1354

    Article  PubMed Central  PubMed  Google Scholar 

  39. Pabinger C, Berghold A, Boehler N, Labek G (2013) Revision rates after knee replacement. Cumulative results from worldwide clinical studies versus joint registers. Osteoarthritis Cartilage 21(2):263–268

    Article  CAS  PubMed  Google Scholar 

  40. Havelin L (1995) Hip arthroplasty in Norway 1987–1994. The Norwegian Arthroplasty Register. University of Bergen

  41. Tunis SR, Stryer DB, Clancy CM (2003) Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA 290(12):1624–1632

    Article  CAS  PubMed  Google Scholar 

  42. Sedrakyan A, Paxton EW, Phillips C, Namba R, Funahashi T, Barber T, Sculco T, Padgett D, Wright T, Marinac-Dabic D (2011) The International Consortium of orthopaedic registries: overview and summary. J Bone Joint Surg Am 93(3):1–12

    PubMed  Google Scholar 

  43. Michael S, Lauer MD, D'Agostino RB (2013) The randomized registry trial — the next disruptive technology in clinical research? N Engl J Med 369:1579–1581

    Article  Google Scholar 

  44. Hassenpflug J (2011) Das Endoprothesenregister Deutschland am Start. Dtsch Med Wochenschr 136:59

    Article  Google Scholar 

  45. Barsoum WK, Higuera CA, Tellez A, Klika AK, Brooks PJ, Patel PD (2012) Design, implementation, and comparison of methods for collecting implant registry data at different hospital types. J Arthroplasty 27(6):842–850

    Article  PubMed  Google Scholar 

  46. Hassenpflug J (2012) The German arthroplasty register EPRD. structure, procedures and organisation. An overview presented at the 2012 EFFORT Congress in Berlin. http://www.ear.efort.org/downloads/E-Book%20EPRD_German%20Arthroplasty%20Register_EFORT%20Berlin%202012.pdf

  47. Paxton L, Low R, Fithian DC (2008) Are gender-specific implants necessary for total knee replacement? Poster at the American Academy of Orthopaedic Surgeons 75th Annual Meeting

  48. Liebs TR, Melsheimer O, Hassenpflug J (2014) Wie können Endoprothesenregister frühzeitig systematische Schadensfälle detektieren? Orthopäde 43(6):549-554

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Correspondence to Joachim Hassenpflug.

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J. Hassenpflug und T.R. Liebs geben an, dass kein Interessenkonflikt besteht.

Dieser Beitrag beinhaltet keine Studien an Menschen oder Tieren.

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Hassenpflug, J., Liebs, T. Register als Werkzeug für mehr Endoprothesensicherheit. Bundesgesundheitsbl. 57, 1376–1383 (2014). https://doi.org/10.1007/s00103-014-2057-6

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