Trial document




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  DRKS00017435

Trial Description

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Title

Feasibility study on osteoarthritis prevalence of amputees fitted with microprocessor controlled knee joints compared to mechanical systems

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

It is assumed that after a lower limb amputation the risk of pain and limitations in the non amputated leg also of back pain is increased. There are many older studies analysing the prevalence and consequence of these long term damages. Additionally some hints could be found showing a relationship with the quality of the prosthetic treatment.
Therefore, it is important to generate new data for the prevalence of these long term damages and to compare the data between two Groups of prosthetic knee Joints. With these data it could be possible to reduce the long term damages for the amputees by choosing the appropriate knee Joint. Therefore, in the projected study amputees with different kinds of prosthetic knees will be analysed.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017435
  •   2019/06/12
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  •   no
  •   Approved
  •   Bo/23/2019, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

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Health Condition or Problem studied

  •   M15-M19 -  Arthrosis
  •   M54.9 -  Dorsalgia, unspecified
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Interventions/Observational Groups

  •   transfemoral amputees with MPK
  •   transfemoral amputees with non MPK
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Prevention
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Primary Outcome is the prevalence of clinical Symptoms of knee osteoarthritis on the sound side using the ACR criteria amputees with and without MPK

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Secondary Outcome

Secundary Outcomes are clinical signs of hip, knee-, ankle- and foot osteoarthritis, backpain, patients mobility, biomechanical parameters for walking on level ground, stairs and ramps.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2019/06/27
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   40   Years
  •   80   Years
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Additional Inclusion Criteria

• Patient is 40-80 year old
• Patient is male
• Patient is able to express the consent for the study independently
• Patient agree with the course of the study
• Patient is transfemoral amputated or kneedisarticulated
• the Amputation is unilateral
• Patient has at least mobility 2
• Patient is at least amputated since 5 years at the beginning of the analysis
• Patient use the appropriate knee Joint 3 years at the beginning of the analysis

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Exclusion Criteria

• Patient with socket problems restricting mobility
• Patients with diagnosed orthopaedic and neurologic impairments on the non amputated side independently of the amputation
• Patient is not able/ won't attend the orders
• Using a transverse-oval prosthetic socket
• Using a microprocessor controlled foot

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Addresses

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    • Ottobock SE & Co. KGaA
    • Max-Näder-Straße 15
    • 37115  Duderstadt
    • Germany
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    • Ottobock SE & Co. KGaA
    • Ms.  Eva  Pröbsting 
    • Hermann-Rein-Str. 2a
    • 37075  Göttingen
    • Germany
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    • Ottobock SE & Co. KGaA
    • Ms.  Eva  Pröbsting 
    • Hermann-Rein-Str. 2a
    • 37075  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Ottobock SE & Co. KGaA
    • Max-Näder-Straße 15
    • 37115  Duderstadt
    • 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.