Trial document




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  DRKS00016356

Trial Description

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Title

Efficacy of ankle orthoses in the reduction of mechanical ankle instability

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Trial Acronym

3SAM-L3

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URL of the Trial

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Brief Summary in Lay Language

Chronic ankle instability may be divided into mechanical and functional instability. For the treatment of mechanical insufficiencies wearing an ankle orthosis is an established method. However, the exact efficacy of ankle orthoses in mechanical ankle instability is still unknown.
Therefore the goal of the present study is the evaluation of mechanical ankle instability using functional 3D-MRI and quantifying the effect an orthosis might have on this mechanical instability. For a better interpretation this will be compared to values of healthy controls.

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Brief Summary in Scientific Language

Quantifying the mechanical contribution to chronic ankle instability may now be evaluated using functional 3D-MRI (s. Wenning et al. 2019). The efficacy of an ankle-orthosis on improving the ankl joint excursion will be evaluated in this study using this novel method.

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

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00016356
  •   2019/11/05
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  •   yes
  •   Approved
  •   118/19, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Healthy volunteers
  •   M25.37 -  [generalization M25.3: Other instability of joint]
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Interventions/Observational Groups

  •   Persons suffering from chronic ankle instability. There will be data acquired using dynamic 3D-MRI with and without an ankle orthosis. Aim of the intervention (wearing the orthosis) is to evaluate the effect on ankle instabiilty using dynamic 3D-MRI.
  •   Healthy controls
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Quantification of the change in mechanical ankle instability / incongruency

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Secondary Outcome

comparison with controls

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/11/10
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Inclusion criteria
Controls: (n=25)
• no previous lesion of lateral ligaments
• stable during clinical examination
• CAIT-Score >24
• age 18-35
• Accordance with matching criteria when compared to controls

mechanical ankle instability group (MAI) – (n=25)
• CAI symptoms fort at leat 6 months
• No acute ankle sprain before examination
• previous operation on lower extremity
• pathological talar tilt and anterior drawer during clinical examination
• CAIT-Score ≤24
• Age 18-35

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Exclusion Criteria

Exclustion criteria (both groups)
- Lesion of the ankle joint that requires intervention. - History of ankle fracture or similar injury of the lower extremity
- contra-indications to mri like pacemakert etc.
- pain when performing full range-of-motion passive exercises
- pain, feeling uncomfortable while wearing the orthosis or during functional measurement.

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Addresses

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    • Institut für Sport und SportwissenschaftAlbert-Ludwigs Universität Freiburg
    • Mr.  Prof. Dr.   Albert  Gollhofer 
    • Schwarzwaldstr. 175
    • 79117  Freiburg
    • Germany
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    • Klinik für Orthopädie und UnfallchirurgieUniversitätsklinikum Freiburg i.B.
    • Mr.  Dr.  Markus  Wenning 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Klinik für Orthopädie und UnfallchirurgieUniversitätsklinikum Freiburg i.B.
    • Mr.  Dr.  Markus  Wenning 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Fa. Bauerfeind AG
    • Triebeser Str. 16
    • 07937  Zeulenroda
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2020/05/12
  •   50
  •   50
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Trial Publications, Results and other Documents

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