Trial document





This trial has been registered retrospectively.
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  DRKS00016783

Trial Description

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Title

Conservative Therapy of medial Osteoarthritis of the Knee: Comparison of an ankle-foot-orthosis with lateral wedge insoles in a cross-over study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study compares different orthopedic devices in the treatment of osteoarthritis of the knee, how they work and in which patients they work best.
Patients with knee osteoarthritis are given an orthosis reaching from the foot to the shank as well as a shoe insole with a wedge at the outer side, each for 6 weeks. Before using the devices and after 6 weeks with each device gait analysis is performed to evaluate the effects of both devices on the knee and ankle joints. As this patient group often suffers instability and changes of the ankle joint, we evaluate how the ankle joint function influences the devices' effects.
Patients also receive questionnaires to find out what effect the devices have on pain and quality of life.
This study will help to understand how orthopedic devices help patients with knee osteoarthritis. It is intended to show which device is best suited for which patient group.

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Brief Summary in Scientific Language

This study compares the clinical and biomechanical effects of different orthopedic devices in the treatment of medial knee osteoarthritis. It aims to evaluate the ankle joint function as a determining factor for response to each of the devices tested. This seems especially important as patients with medial knee osteoarthritis tend to show changes in ankle joint biomechanics.
Patients with knee osteoarthritis are fitted with an ankle foot orthosis (Ottobock® Agilium Freestep) and a laterally wedged insole, each for 6 weeks. At the beginning of the study and after each 6 week period, instrumented gait analysis is performed to evaluate the effects of both devices on the lower extremities. Ankle joint function is quantified in a trial on an inclined surface as part of one gait analysis.
Patients receive standardized questionnaires for evaluation of the effects on osteoarthritis symptoms and quality of life (EQ-5D, American Knee Society Score, Oxford 12 Knee Score and FFbH-OA: functional questionnaire of Hannover for OA).
This study will show differences of biomechanical and clinical effects of different devices and may contribute to evidence-based recommendation of each orthopedic device.

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Organizational Data

  •   DRKS00016783
  •   2019/02/26
  •   [---]*
  •   yes
  •   Approved
  •   S-021/2018, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   M17.9 -  Gonarthrosis, unspecified
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Interventions/Observational Groups

  •   6 weeks ankle-foot orthosis "Agilium Freestep" (Ottobock), then 6 weeks laterally wedged insole
  •   6 weeks laterally wedged insole, then 6 weeks ankle-foot-orthosis (AFO) "Agilium Freestep"
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Change of external knee adduction moment (KAM) and ankle biomechanics as determining factor for the change in KAM. Measurement by 3D instrumented gait analysis with each orthopedic device after 6 weeks of use of the device, compared with gait analysis without any device.

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Secondary Outcome

Changes in osteoarthritis symptoms (American Knee Society Score, Oxford 12 Knee Score and FFbH-OA: functional questionnaire of Hannover for OA) and health-related quality of life (EQ-5D) after 6 and 12 weeks compared to the beginning of the study.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/05/16
  •   50
  •   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

Primary and secondary osteoarthritis of the knee (Kellgren & Lawrence 1-3), physiotherapy, oral analgetics and other external therapies as possible accompanying therapies, no history of orthosis or insoles or orthopedic shoe modifications for osteoarthritis of the knee, competency to give consent

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Exclusion Criteria

history of surgery for osteoarthritis, invasive therapies (e.g. injections), Kellgren & Lawrence 4, lack of physical capacity or lack of compliance, cancellation if withdrawal of consent

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg, Klinik für Orthopädie und Unfallchirurgie
    • Mr.  Dr. med.  Martin  Schwarze 
    • Schlierbacher Landstraße 200a
    • 69118  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg, Klinik für Orthopädie und Unfallchirurgie
    • Mr.  Dr. med.  Martin  Schwarze 
    • Schlierbacher Landstr. 200a
    • 69118  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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