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

NCT ID: NCT03444441

Last Updated: 2021-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-15

Study Completion Date

2019-03-14

Brief Summary

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

Detailed Description

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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.

Conditions

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Foot Diseases Ankle Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Foot or ankle surgery

Surgery for foot or ankle

Intervention Type PROCEDURE

Other Intervention Names

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correction forefoot correction midfoot correction hindfoot correction ankle combined correction procedures for osteoarthritis foot or ankle procedures for instability ankle correction flatfoot correction cavus foot correction equinus foot procedures for Diabetic ulcer procedures for Charcot procedures for tendinopathy Achilles procedures for tendinopathy other osteosynthesis Other foot or ankle surgery

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Finland Hospital District

OTHER

Sponsor Role collaborator

Seinajoki Central Hospital

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jussi Repo

Resident surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Central Finland Central Hospital

Jyväskylä, , Finland

Site Status

Oulu University Hospital

Oulu, , Finland

Site Status

Seinäjoki Central Hospital

Seinäjoki, , Finland

Site Status

Peijas Hospital

Vantaa, , Finland

Site Status

Countries

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Finland

Other Identifiers

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FA2018

Identifier Type: -

Identifier Source: org_study_id

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