Trial document




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  DRKS00015471

Trial Description

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Title

Multimodal approach in long term longitudinal in-vivo monitoring the clinical outcomes of graft maturation of injected matrix-assisted autologous chondrocyte transplantation in individual patients – clinical, morphological MRI and biochemical quantitative T2-mapping, T1rho and diffusion-weighted-imaging.

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Trial Acronym

ACTIVE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Autologous chondrocyte transplantation (ACTinject) is an innovative arthroscopic treatment for cartilage damage. Reliable methods for early detection of therapeutic failure, long-term results or event history analysis are missing to this day.
In this study patients after ACTinject will receive MRI examinations and clinical checkups for 36 months to develop a new detection method for early impaired cartilage maturation as well as to predict long-term results.
Study participants receive clinical-orthopedic as well as MRI-examinations 3, 6, 12, 24 and 36 months after ACTinject of the knee.

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Brief Summary in Scientific Language

Autologous chondrocyte transplantation injection (ACTinject) is an innovative method to treat cartilage defect arthroscopically by directly modifying the transplant to the cartilage defect. Established clinical scores (e.g. visual analog scale, knee injury and osteoarthritis outcome score, tegner score, short form-36 health Survey, physical and mental component scores) correlate inadequately with image findings. Radiological scores (e.g. magnetic resonance observation of cartilage repair tissue) not reliable for detection of transplant impairment. Furthermore long term studies exceeding a duration of 10 months after ACTinject are still missing and the evaluation of therapeutic failures were not systematically evaluated in previous studies, and radiological long-term data is missing due to this point. Therefore the aim of this study is to follow-up of patients after ACTinject for a duration of 36 months to aquire MRI as well as clinical parameters to evaluate and predict transplant failure and long term outcome.

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Organizational Data

  •   DRKS00015471
  •   2019/04/16
  •   [---]*
  •   yes
  •   Approved
  •   18-672, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

  •   LMU-RAD00059  (interne Studiennummer)
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Health Condition or Problem studied

  •   M23.99 -  [generalization M23.9: Internal derangement of knee, unspecified]
  •   M22.4 -  Chondromalacia patellae
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Interventions/Observational Groups

  •   Patients receive clinical-orthopedic as well as non contrast MRI-examinations (3 Tesla, Philips Ingenia or Siemens Magnetom Skyra) 3, 6, 12, 24 and 36 months after ACTinject treatment.
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Characteristics

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

Aim of this study is the explorative comparison of patients after ACTinject treatment for a duration of 36 months concerning clinical as well as MRI-parameters.

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Secondary Outcome

Temporal course of MRI-parameters in line with graft maturation.
Correlation between clinical Parameters an MRI-parameters during different timepoints (3, 6, 12, 24 and 36 months).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/04/24
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

minimum age 18 years, maximum age 60 years. Isolated cartilage defect of at least 2 cm² size. ACTinject treatment of the knee at least 3 month previously. Signed informed consent form.

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Exclusion Criteria

More then 2 cartilage defects. (Osteo-)arthritis. Instability of the knee joint. Incomplete follow-up data. General contraindications for MRI.

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Addresses

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    • Klinikum der Universität München, Campus Großhadern
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Klinik und Poliklinik für Orthopädie, Physikalische Medizin und RehabilitationKlinikum der Universität München
    • Mr.  PD Dr.  Thomas  Niethammer 
    • Marchioninistrasse 15
    • 81377   München
    • Germany
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    • Klinikum der Universität München
    • Ms.  Prof.  Andrea  Baur-Melnyk 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
    • Ms.  Christel  Besseler 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
    • Mr.  Prof.  Jens  Ricke 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    •   (089) 4400-4400 72750
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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.