Trial document




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  DRKS00009401

Trial Description

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Title

Development and validation of a disease specific, patient oriented questionnaire to determine the functional and pain associated limitations of patients with osteochondrosis dissecans tali (ODT).

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Trial Acronym

ODT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the dissertation is to develop a valid, patient oriented and disease specific questionnaire to determine the pain-level, symptoms and the functional limitations of patients with osteochondrosis dissecans tali (ODT).
The items for the questionnaire are provided by literature research and documented courses of the disease. A meeting of experts including orthopaedists, orthopaedic surgeons and physiotherapists is planned after that to generate more questionnaire-items.
The constituted items for the questionnaire are going to be tested on a small group of partients and are going to be optimised in a subsequent expert’s meeting . The revised questionnaire is then going be tested for validity and reliability on different groups (patients with ODT, athletes activly engaged in sports with a high-risk-profil regarding ODT, control group).

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Brief Summary in Scientific Language

The aim of the dissertation is to develop a valid, patient oriented and disease specific questionnaire to determine the pain-level, symptoms and the functional limitations of patients with osteochondrosis dissecans tali (ODT).
The items for the questionnaire are provided by literature research and documented courses of the disease. A meeting of experts including orthopaedists, orthopaedic surgeons and physiotherapists is planned after that to generate more questionnaire-items.
The constituted items for the questionnaire are going to be tested on a small group of partients and are going to be optimised in a subsequent expert’s meeting . The revised questionnaire is then going be tested for validity and reliability on different groups (patients with ODT, athletes activly engaged in sports with a high-risk-profil regarding ODT, control group).

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Organizational Data

  •   DRKS00009401
  •   2015/10/12
  •   [---]*
  •   yes
  •   Approved
  •   366/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   M93.2 -  Osteochondritis dissecans
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Interventions/Observational Groups

  •   Patients: ODT questionnaire, anamnesis
  •   athletes activly engaged in sports with a high-risk-profil regarding ODT: ODT questionnaire, anamnesis
  •   probands who aren't activly engaged in sports with a high-risk-profil regarding ODT: ODT questionnaire, anamnesis
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Characteristics

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

Valid, patient-oriented and disease-specific questionnaire for patients with ODT.

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Secondary Outcome

-

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2015/12/01
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Patients with ODT and German as their mother tongue.
Probands with German as their mother tongue activly engaged in sports with a high-risk-profil regarding ODT.
Probands with German as their mother tongue not engaged in sports with a high-risk-profil regarding ODT.

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Exclusion Criteria

Patients and probands with a neurological, psychiatrical or rheumatical disease, diabetes, pregnant women.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Alberts-Ludwigs-Universität Freiburg,Institut für Sport
    • Mr.  Prof. Dr.  Albert  Gollhofer 
    • Schwarzwaldstr. 175
    • 79117  Freiburg
    • Germany
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    •   [---]*
    •   [---]*
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    •   [---]*
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    • Alberts-Ludwigs-Universität Freiburg,Institut für Sport
    • Mr.  Prof. Dr.  Albert  Gollhofer 
    • Schwarzwaldstr. 175
    • Freiburg
    • Germany
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    •   [---]*
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    • Sportmedizinisches Institut Frankfurt am Main e.V.
    • Mr.  Prof. Dr. med.  Heinz  Lohrer 
    • Otto-Fleck-Schneise 10
    • 60528  Frankfurt
    • Germany
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    •   069-678009-33
    •   [---]*
    •   [---]*
    •   [---]*
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    • Sportmedizinisches Institut Frankfurt am Main e.V.
    • Mr.  Prof. Dr. med.  Heinz  Lohrer 
    • Otto-Fleck-Schneise 10
    • 60528  Frankfurt
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Sportmedizinisches Institut Frankfurt am Main e.V.
    • Mr.  Prof. Dr. med.  Heinz  Lohrer 
    • Otto-Fleck-Schneise 10
    • 60528  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Alberts-Ludwigs-Universität Freiburg,Institut für Sport
    • Mr.  Prof. Dr.  Albert  Gollhofer 
    • Schwarzwaldstr. 175
    • 79117  Freiburg
    • 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.