Trial document





This trial has been registered retrospectively.
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  DRKS00007585

Trial Description

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Title

Validity, reliability and responsiveness of the German version of MOXFQ/SEFAS/HOOS

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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

Reliability, Validity and Responsiveness of the German MOXFQ/SEFAS/HOOS in patients with foot and ankle/hip surgery

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Organizational Data

  •   DRKS00007585
  •   2017/10/27
  •   [---]*
  •   yes
  •   Approved
  •   15-252, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   i.a. Hallux valgus
    coxarthrosis
  •   M20 -  Acquired deformities of fingers and toes
  •   M16 -  Coxarthrosis [arthrosis of hip]
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Interventions/Observational Groups

  •   Determination of reliability, validity and responsiveness by questioning the participants three times: t1: 3-5 days before the planned surgery; t2: on day of surgery; t3: 5-6 months after surgery.

    Patients with planned foot and ankle surgery:
    t1: MOXFQ, SEFAS
    t2: MOXFQ, SEFAS, SF-36, NRS, FAOS
    t3: MOXFQ, SEFAS

    Patients with planned hip surgery:
    t1: HOOS
    t2: HOOS, OHS, SF-36, NRS
    t3: HOOS
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Characteristics

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

Criteria for primary outcome:
- determination of reliability via chronbachs alpha and intraclass correlation coefficient (ICC)
- determination of criteria- and constructvalidity with spearman non-parametric correlation
- the determination of Floor and Ceiling effects
- determination of responsiveness via Effect Size (ES), Standardized response mean (SRM)
- determination of Minimal important change: Minimal clinical difference (MDC), Standard error of measurement (SEM)

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/01/01
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

MOXFQ/SEFAS: panned foot or ankle surgery, majority

HOOS: planned hip surgery, majority

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Exclusion Criteria

minority, incomprehension of german language

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Addresses

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    • LVR-Klinik für Orthopädie Viersen
    • Horionstr. 2
    • 41749  Viersen
    • Germany
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    • LVR-Klinik für Orthopädie Viersen
    • Mr.  Dr  Dariusch  Arbab 
    • Horionstr. 2
    • 41749  Viersen
    • Germany
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    •   02162 9660
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    •   darbab at gmx.de
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    • LVR-Klinik für Orthopädie Viersen
    • Mr.  Dr.  Dariusch  Arbab 
    • Horionstr. 2
    • 41749  Viersen
    • Germany
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    •   02162 9660
    •   [---]*
    •   darbab at gmx.de
    •   [---]*
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Sources of Monetary or Material Support

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    • LVR-Klinik für Orthopädie Viersen
    • Horionstr. 2
    • 41749  Viersen
    • 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.