Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00005617

Trial Description

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Title

A Registry for Evaluation of Efficiency and Safety of Surgical Treatment of Cartilage Defects of the knee (German Cartilage Registry – DGOU)

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Trial Acronym

The German Cartilage Registry (KnorpelRegister DGOU)

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URL of the Trial

http://www.knorpel-register.info/

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Brief Summary in Lay Language

On the initiative of the "Working Group Clinical Tissue Regeneration of the German Society for Orthopaedics and Trauma Surgery ( DGOU ) " a database that documents the scientific and multicentric personal data of patients following surgically treated cartilage lesions. In contrast to controlled clinical studies, in particular a review of the effectiveness of surgical therapies cartilage in terms of symptom relief , functional outcome and also in relation to the avoidance of osteoarthritis of the knee joint affected in a large cohort of non- selected patients is aim oft he registry . Other objectives include the acquisition of procedural complications and evaluation oft he ssafety of different surgicaltreatments for patients with isolated cartilage damage. All patients preoperatively according to this present agreement entered into the database and evaluated the complaints or function of the affected joint on the basis of standardized scoring systems. The follow-up is done with the identical scores after 6, 12 , 24, 36 and 60 months. Operative complications and revision are systematically recorded and documented. The indication for surgical cartilage treatment ond the type of treatment applied is independent of the participation in the study in all patients.

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Brief Summary in Scientific Language

On the initiative of the "Working Group Clinical Tissue Regeneration of the German Society for Orthopaedics and Trauma Surgery ( DGOU ) " a database that documents the scientific and multicentric personal data of patients following surgically treated cartilage lesions. In contrast to controlled clinical studies, in particular a review of the effectiveness of surgical therapies cartilage in terms of symptom relief , functional outcome and also in relation to the avoidance of osteoarthritis of the knee joint affected in a large cohort of non- selected patients is aim oft he registry . Other objectives include the acquisition of procedural complications and evaluation oft he ssafety of different surgicaltreatments for patients with isolated cartilage damage. All patients preoperatively according to this present agreement entered into the database and evaluated the complaints or function of the affected joint on the basis of standardized scoring systems. The follow-up is done with the identical scores after 6, 12 , 24, 36 and 60 months. Operative complications and revision are systematically recorded and documented. The indication for surgical cartilage treatment ond the type of treatment applied is independent of the participation in the study in all patients.

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Organizational Data

  •   DRKS00005617
  •   2014/01/03
  •   [---]*
  •   yes
  •   Approved
  •   105/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   All patients who undergo surgical cartilage/bone repair in one of the participating centers
  •   M23 -  Internal derangement of knee
  •   M93 -  Other osteochondropathies
  •   M94 -  Other disorders of cartilage
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Interventions/Observational Groups

  •   Any surgical treatment for cartilage/bone defect
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Characteristics

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

Knee part: IKDC Score at 60 months

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Secondary Outcome

IKDC Score at 6, 12, 24, 36 and 120 Months
KOOS Score at 6, 12, 24, 36, 60 and 120 Months

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2013/10/17
  •   10000
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

all patients who undergo surgical cartilage repair in participating centers

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Exclusion Criteria

Patient declines participation

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Orthopädie und Unfallchirurgie
    • Mr.  Prof. Dr. med.  Philipp  Niemeyer 
    • Hugstetter Str. 55
    • 79106  Freiburg im Breisgau
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Orthopädie und Unfallchirurgie
    • Mr.  Prof. Dr. med.  Philipp  Niemeyer 
    • Hugstetter Str. 55
    • 79106  Freiburg im Breisgau
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Mr.  Prof. Dr.  Philipp  Niemeyer 
    • Hugstetter Str. 55
    • 79102  Freiburg
    • Germany
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    • Deutsche Arthrose Hilfe e.V.
    • Neue-Welt-Str. 4-6
    • 66740  Saarlouis
    • Germany
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    • Stiftung Oskar-Helene-Heim
    • Walterhöfer Str. 11
    • 14165  Berlin
    • 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.