Estimation of the Minimal Important Difference and Validation of Foot and Ankle Instruments

Foot Diseases Clinical Trial

Official title:

Estimation of the Minimal Important Difference and Validation of Finnish Versions of Foot and Ankle Patient-reported Outcome Instruments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444441
• Other study ID #: FA2018
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Ankle Disease
• Foot Diseases

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