Trial document




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  DRKS00000365

Trial Description

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Title

Correlation of clinical outcome with intraarticular cytokine concentrations following cartilage regeneration in knee and upper ankle joint

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Trial Acronym

CORRCYT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Lavage fluids of patients with cartilage lesions or suffering from osteochondrosis dissecans are prospectively collected during an arthroscopy performed for treatment. Patients without cartilage lesions serve as a control group, cartilage defects are treated by microfracturing by Autologous Chondrocyte Implantation, or drilling (ACI). Total protein content and concentrations of Aggrecan, bFGF, IGF-I, BMP-2, BMP-7, and IL-1beta are determined. Clinical status is evaluated using the validated scores (Lysholm, ICRS, AOFAS).

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Brief Summary in Scientific Language

Lavage fluids of patients with cartilage lesions or suffering from osteochondrosis dissecans are prospectively collected during an arthroscopy performed for treatment. Patients without cartilage lesions serve as a control group, cartilage defects are treated by microfracturing by Autologous Chondrocyte Implantation, or drilling (ACI). Total protein content and concentrations of Aggrecan, bFGF, IGF-I, BMP-2, BMP-7, and IL-1beta are determined. Clinical status is evaluated using the validated scores (Lysholm, ICRS, AOFAS).

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Organizational Data

  •   DRKS00000365
  •   2010/03/08
  •   2009/01/12
  •   yes
  •   Approved
  •   335/08, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   U1111-1114-0910 
  •   UKF001822  (Register Klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   M93.2 -  Osteochondritis dissecans
  •   M94.26 -  [generalization M94.2: Chondromalacia]
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
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  •   Prognosis
  •   Single (group)
  •   N/A
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Primary Outcome

Lysholm Score, IKDC Score: validated scores about knee function

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Secondary Outcome

Noyes Score, the Medical Outcomes Study Short Form-36 (SF-36), and visual analog scales (VAS) for knee pain strength and frequency: parameter for life quality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2009/08/30
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

performance of an arthroscopy of the knee joint or the upper ankle joint, patients in the control group have no cartilage lesion in MRI and diagnostic arthroscopy, patients undergoing microfracturing or ACI have full thickness cartilage lesions graded III and IV according to ICRS classification of various size, agreement to participate in the study, age >18 years and <65 years

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Exclusion Criteria

alcohol or drug abuse, mental retardation with incapability to complete the necessary self-reports, joint effusion >30ml, persistent knee oder upper ankle joint instability, infection

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Addresses

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    • Schatzmeister der AO Deutschland
    • Mr.  Prof. Dr. med.  Friedrich  Hahn 
    • IM KÄLBLESRAIN 1-3
    • 73430  AALEN
    • Germany
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    • Universitätsklinik Freiburg Dep. Orthopädie und Traumatologie
    • Mr.  Dr. med.  Hagen  Schmal 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinik Freiburg Dep. Orthopädie und Traumatologie
    • Mr.  Dr. med.  Hagen  Schmal 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • AO Deutschland
    • Mr.  Prof. Dr. med.  Friedrich  Hahn 
    • IM KÄLBLESRAIN 1-3
    • 73430  AALEN
    • 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.