Trial document




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  DRKS00000729

Trial Description

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Title

molecular MRI in knee osteoarthritis: application and validation of biochemically sensitive MRI-sequences

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Trial Acronym

KORdGEMRIC

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URL of the Trial

http:///

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Brief Summary in Lay Language

Early cartilage degeneration within the process of osteoarthritis can not be demonstrated with standard MRI images (magnetic resonance imaging). This study investigates the use of biochemically sensitive MRI-sequences for the appreciation of cartilage quality. In the course of a validation study in 40 knee osteoarthritis patients, who are treated with a total knee prosthesis, the MRI-techniques will be compared to one-another, validated histologically and tested towards their clinical applicability. Hypothesis: cartilage degeneration can be demonstrated with the aid of molecular cartilage MRI. Changes can be reproduced histologically.

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Brief Summary in Scientific Language

The early detection of cartilage damage within the process of osteoarthritis (OA) is important for the understanding of the disease and for the developement, implementation and follow up of surgical and non-surgical therapy procedures. Signs of OA, that are visible on the x-ray or on a standard MRI are signs of advanced OA. The loss of collagen integrity and a reduction of glycosaminoglycans (GAG), however, are known early occurences is the developement of OA. The MRI-techniques T2/T2*-mapping, T1rho and delayed Gadolinium Enhanced MRI of Cartilage (dGEMRIC) are biochemically sensitive MRI techniques for the in vivo appreciation of colllagen structure (T2/T2*) and GAG-content (T1rho, dGEMRIC). In the course of a validation study in knee osteoarthritis patients, who are treated with a total knee prosthesis. The MRI-techniques should be compared to one-another, validated histologically and tested towards their clinical applicability.

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Organizational Data

  •   DRKS00000729
  •   2011/02/21
  •   [---]*
  •   yes
  •   Approved
  •   3304, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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

  •   M17.1 -  Other primary gonarthrosis
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Interventions/Observational Groups

  •   Observation group: 40 Patients who are planned to receive a total knee replacement. X-rays according to the house standard. Measuring of x-ray parameters (grade of osteoarthritis, minimal joint space widdth). Clinical examination and stipulation of of clincal scores (knee society score, SF 36).
    MRI of the Patient. Measurement of T1 times in the different regions of the joint. Surgery and exploitation of the preparation. MRI of the bone-cartilagae-block. Measurement of T1 times in the different regions of the preparat.
    Histological evaluation of the preparat. Comparison of MRI-parameters in vivo and in vitro with clinical-radiographic parameters and with histology as gold standard.
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Characteristics

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

Hypothesis: cartilage degeneration can be demonstrated with the aid of molecular cartilage MRI. Changes can be reproduced histologically

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Secondary Outcome

no secondary outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2011/06/15
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients, who are diagnosed with a knee osteoarthritis and are planned to receive a total knee replacement.

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Exclusion Criteria

no written consent after information; technical implants, metal fragments; non-removable decoration; claustrophobia; cannot ly down for a long time including lung dysfunction or reflux; pregnancy; breast feeding mother; allergic reaction to contrast agent; allergic asthma; renal dysfunction - to be demonstrated in a creatinin-value within normal range; liver dysfunction; acute or chronic infections, epilepsia, brain disease, tumors.

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Addresses

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    • Universitätsklinikum Düsseldorf
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Orthopädische Klinik Universitätsklinikum Düsseldorf
    • Mr.  Dr. med.   Christoph   Zilkens 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Orthopädische Klinik Universitätsklinikum Düsseldorf
    • Mr.  Dr. med.   Christoph   Zilkens 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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    • Orthopädische Klinik Universitätsklinikum Düsseldorf
    • Mr.  Dr. med.   Christoph   Zilkens 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.