Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003430

Trial Description

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Title

German Arthroplasty Registry

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Trial Acronym

EPRD

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URL of the Trial

http://www.eprd.de

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Brief Summary in Lay Language

Artificial joint replacement is one of the biggest success stories of modern medicine. Pain, functional disorders and restricted mobility can be treated effectively and durably in particular in the hip and knee joint. In the eyes of the public joint replacement has meanwhile become a sort of standard intervention that is associated with high expectations. In many studies the success rate in terms of implant survival is reported to be approximately 95 % at 10 years.
Hip and knee replacement rank among the most common surgical procedures throughout Germany. In 2010, for instance, in summary about 390,000 joint replacements were performed in Germany. Of these 157,712 interventions were total hip arthroplasties, 24,948 hip revision surgeries, and about 50,000 hip replacements after femoral neck fractures. In the same year 146,233 knee prostheses were implanted and 12,215 artificial knee joints revised.
The prevalence of both hip and knee arthroplasty
interventions is exceptionally high in Germany. In view of an increasingly aging population several authors expect a further increase in joint replacement surgery in Western industrialised nations.

The German Arthroplasty Register is supposed to provide a nationwide record of implant survival times. Data collection is organised in such a way as to keep additional administrative processing at a minimum, which was an essential goal in project planning, and strictly adheres to the existing data protection regulations. As important stakeholders in health care, apart from the Orthopaedic Society also major health care insurance providers, manufacturers, and the BQS Institute (Institute for Quality and Patient Safety) are directly involved to ensure long-term operation of the Register and cross-functional cooperation.

The aim of the Germany Arthroplasty Register is to obtain a valid database on the arthroplasties performed in Germany, in order 1.) to detect implants that have a higher than expected revision rate, 2.) to ensure the quality of care for patients and 3.) to reduce the number of revisions.

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Brief Summary in Scientific Language

The German Arthroplasty Register is supposed
to provide a nationwide record of implant survival times. Data collection is organised in such a way as to keep additional administrative processing at a minimum, which was an essential goal in project planning, and strictly adheres to the existing data
protection regulations. As important stakeholders in health care, apart from the Orthopaedic Society also major health care insurance providers, impant manufacturers, and the BQS Institute (Institute for Quality and Patient Safety) are directly involved to ensure long-term operation of the Register and cross-functional cooperation.

The German Association of Orthopaedics and Orthopaedic Surgery (DGOOC) had been trying to establish an arthroplasty register for nearly two decades. From 1997 the Deutsche Endoprothesenregister e.V. (German Arthroplasty Register Association) collected arthroplasty data
on a voluntary basis. However, when BQS started nationwide collection of structural and process quality data, this register was ceased not least due to lack of systematic funding. Subsequently comprehensive concepts were drawn up for a statutory Arthroplasty Register organised through
External Quality Assurance. In 2009, after the German External Quality Assurance provider had been changed, the implementation of a National Arthroplasty Register could no longer be expected to be realised in the short to medium run.

In 2010 the German Association of Orthopaedics and Orthopaedic Surgery (DGOOC) therefore initiated the foundation of the German Arthroplasty Register “Endoprothesenregister Deutschland gGmbH” (EPRD). The EPRD is a not-for-profit society and a subsidiary of the scientific National Orthopaedic Association DGOOC. Structured cooperation was built up across long existing sectoral boundaries among the Orthopaedic Society (DGOOC), the Arthroplasty and Implants Division within the German Medical Technology Association (BVMed), and the hospitals. On the initiative of the DGOOC the essential key partners in health care – the Federation of Local Health Insurance Funds (AOK-Bundesverband), the Association of Substitute Health Insurance Funds (vdek – Verband der Ersatzkassen), implant manufacturers via the BVMed, as well as the BQS Institute – joined forces in a common project, the EPRD. As Members of the Executive Committee all partners have a decisive share in steering the German Arthroplasty Register. They are supported by a Council composed of high-ranking personalities from the public, political and scientific sector.
To give appropriate consideration to all requirements including statutory provisions, the EPRD has concluded mutual, long-term agreements with all partners. The financing concept provides balanced contributions from health insurance providers, manufacturers and the hospitals.
The findings obtained will be made accessible to the scientific community as well as to the general public through regular evaluations, publications and presentations.
Through close feedback via the Orthopaedic Society these findings can be implemented in everyday treatment practice directly and in the short run, which will lead to an increase in patient safety.

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Organizational Data

  •   DRKS00003430
  •   2013/06/05
  •   [---]*
  •   yes
  •   Approved
  •   D 473/11, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  •   U1111-1126-4984 
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Health Condition or Problem studied

  •   M16 -  Coxarthrosis [arthrosis of hip]
  •   M17 -  Gonarthrosis [arthrosis of knee]
  •   T84.0 -  Mechanical complication of internal joint prosthesis
  •   T84.5 -  Infection and inflammatory reaction due to internal joint prosthesis
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Interventions/Observational Groups

  •   Registration of all implants used for knee or hip replacement surgery in all patients undergoing primary or revision joint arthroplasty. In addition to routine reimbursement data the hospitals scan the barcode of the implants and record previous surgery in case of primary arthroplasty, and record the reason for revision in case of revision surgery
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Survival time of the implant

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2012/12/01
  •   [---]*
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

1. Primary or revision hip or knee replacement surgery
2. Patient is insured at a participating health insurance (as of Dec 2012: AOK or VDEK)
3. Hospital performing the surgery is participating at the registry
4. Written informed consent of the patient

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Exclusion Criteria

None

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Addresses

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    • Geschäftsstelle EPRD gGmbH Langenbeck-Virchow-Haus
    • Luisenstr. 58/59
    • 10117  Berlin
    • Germany
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    • Universitätsklinikum Schleswig-Holstein, Campus Kiel Orthopädische Klinik
    • Mr.  Prof. Dr.  Joachim  Hassenpflug 
    • Michaelisstr. 1
    • 24105  Kiel
    • Germany
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    • BQS Institut für Qualität & Patientensicherheit GmbH
    • Kanzlerstraße 4
    • 40472  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Arthrose-Hilfe e. V.
    • Postfach 11 05 51
    • 60040  Frankfurt/Main
    • Germany
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    • Implantathersteller
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    •   [---]*
    •   [---]*
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    • Krankenhäuser und Kliniken
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • teilnehmende Krankenkassen
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Bundesministerium für Gesundheit (BMG)
    • Rochusstr. 1
    • 53123  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.