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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03444441
Other study ID # FA2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2018
Est. completion date March 14, 2019

Study information

Verified date January 2021
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The present study investigates the minimal important change and validity of foot and ankle measures.


Description:

Patients who are waiting for foot and ankle surgery are recruited from four large referral centers (Peijas Hospital, Seinäjoki Central Hospital, Central Finland Central Hospital, Oulu University Hospital). Participants fill in foot and ankle-specific, generic and sosiodemographic questionnaires on the day of surgery, 6 months after surgery, and 6 months 2 weeks after surgery. Both pen-and-paper and electronic options for completing the questionnaire set are provided. The data obtained from the Foot and ankle outcome score (FAOS), European foot and ankle society (EFAS) score, modified Lower extremity functional scale (LEFS), Visual analog scale foot and ankle (VAS-FA), Manchester Oxford foot and ankle (MOxFA) questionnaire, and the Foot and ankle ability measure (FAAM) are analyzed using the Rasch Measurement Theory and several other psychometric approaches to investigate minimal important change, reliability, responsiveness and validity of foot and ankle PRO instruments.


Recruitment information / eligibility

Status Completed
Enrollment 290
Est. completion date March 14, 2019
Est. primary completion date March 6, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Full understanding of Finnish language - Undergoing foot or ankle surgery - At least 18 years old Exclusion Criteria: - Unbalanced mental disorder such as schizophrenia or depression - Age under 18 - Does not understand Finnish - Undergoing operation other than foot or ankle

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Foot or ankle surgery
Surgery for foot or ankle

Locations

Country Name City State
Finland Central Finland Central Hospital Jyväskylä
Finland Oulu University Hospital Oulu
Finland Seinäjoki Central Hospital Seinäjoki
Finland Peijas Hospital Vantaa

Sponsors (4)

Lead Sponsor Collaborator
Helsinki University Central Hospital Central Finland Hospital District, Oulu University Hospital, Seinajoki Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Minimal important difference Change from baseline scores at 6 months Baseline, 6 months
Secondary Reliability Change from 6 months scores at 6.5 months 6 months, 6.5 months
Secondary General health question Change from baseline scores at 6 months Baseline, 6 months
Secondary General health question Change from baseline scores at 6 months 6 months, 6.5 months
Secondary Global assessment scale Change from baseline scores at 6 months 6 months
Secondary Validity Baseline scores Baseline
Secondary Validity 6 months scores 6 months
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