Trial document





This trial has been registered retrospectively.
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  DRKS00004671

Trial Description

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Title

Acoustic emission analysis for diagnosis of osteoarthritis of the knee compared to magnetic resonance imaging - a pilot study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Many older people suffer from osteoarthritis of the knee. Due to pain and reduced mobility of the joint, those people cannot maintain their level activity, leading to a vicious cycle where pain and inactivity lead to more pain and inactivity. Because osteoarthritis cannot be healed, the end is almost always an surgical procedure for replacement of the knee with an artificial one. On the other hand, the course of osteoarthritis can be influenced and its progress be slowed down or even be brought to a halt by appropriate medical or therapeutic effort. Furthermore, the possibility of cartilage regeneration under optimal circumstances is at least discussed, so that an early diagnosed osteoarthritis could even be healed. However, until now neither suitable diagnostic procedures for an early diagnosis of osteoarthritis nor evidence-based rehabilitative concepts for cartilage healing exist. Therefore it is important to develop such diagnostic tools to be able to assess the effectiveness of newly to be developed medical and therapeutic concepts.
This pilot study is performed to evaluate the so called Acoustic Emission Analysis (AEA ) for early detection of osteoarthritis of the knee and to prepare a larger study.
We will examine participants who will have a MRI because of complaints of the knee. After MRI procedure, they will be examined with the AEA and results from both examinations will be compared.
The goal of the study is to gain first insights about the practicability and applicability of this measurement tool under clinical conditions by comparing results from AEA and MRI.

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Brief Summary in Scientific Language

Osteoarthritis of the knee ist a widespread disease, conveniently resulting in pain, constrained mobility and a reduction of activities and participation. For the diagnosis of osteoarthritis of the knee, no established gold standard exists. According to initial studies, the Acoustic Emission Analysis (AEA) is capabable of detecting early changes in cartilage structure. However, it lacks a comprehensive in vivo validation study of its diagnostic accuracy.
To investigate the diagnostic accuracy of the SEA in a pilot study using magnetic resonance imaging (MRI) as a reference standard. Additionally, potential factors influencing a false positive or negative result as well as the necessary number of participants for a following main study are to be assessed. Because of the pilot character of this study we did not formulate any hyothesis.

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Organizational Data

  •   DRKS00004671
  •   2013/02/13
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  •   yes
  •   Approved
  •   137/08, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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Health Condition or Problem studied

  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   Participants with complaints of the knee.
    All participants are referred for a MRI of the knee for a clinical diagnosis because of their complaints as part of their clinical routine by a doctor. Additionally, they will receive a diagnostic procedere with the Acoustic Emission Analysis .
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Characteristics

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

Diagnosis of osteoarthritos of the knee

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Secondary Outcome

Diagnosis of damages to any ligaments and menisci, average thickness of cartilage, bone fissures, bone bruising, impression fractures and baker cysts of the knee (MRI only)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2008/10/01
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

18 years or older, scheduled MRI of the knee due to complaints of the knee, full load bearing ability of the lower extremities, written consent

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Exclusion Criteria

Not able to perform squats, endoprothesis of the knee, total resection of one or both meniscii, immobilisation of the knee for more than 48 hours during the last 2 weeks, clinical signs of knee instability, genetic diseases with changes in bone or cartilage structure, comorbidities with a reduced physical capacity (heart and neurological diseases, pregnancy, kognitive impairment, acute psychic events, taking blood thinning medications, coagulation disorders, allergic reactions to synthetics or adhesives, any contraindications for MRI

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Addresses

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    • Hochschule für Gesundheit
    • Prof.  Udo  Wolf 
    • Universitätsstraße 105
    • 44789  Bochum
    • Germany
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    • Forschungsgruppe Geriatrie der Charité - Universitätsmedizin Berlin
    • Mr.  Jörn  Kiselev 
    • Reinickendorfer Straße 61
    • 13347  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Philipps-Universität Marburg Fb. 20 - Medizin
    • Baldingerstraße
    • 35032  Marburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2008/11/05
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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.