NCT03444441

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2019

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

January 13, 2018

Last Update Submit

January 15, 2021

Conditions

Foot DiseasesAnkle Disease

Keywords

FootAnkleFinnishValidationFAOSEFASLEFSFAAMVAS-FAMOxFA

Outcome Measures

Primary Outcomes (1)

  • Minimal important difference

    Change from baseline scores at 6 months

    Baseline, 6 months

Secondary Outcomes (6)

  • Reliability

    6 months, 6.5 months

  • General health question

    Baseline, 6 months

  • General health question

    6 months, 6.5 months

  • Global assessment scale

    6 months

  • Validity

    Baseline

  • +1 more secondary outcomes

Interventions

Foot or ankle surgeryPROCEDURE

Surgery for foot or ankle

Also known as: 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

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study recruits adult patients who are undergoing foot or ankle surgery for various reasons.

You may qualify if:

  • Full understanding of Finnish language
  • Undergoing foot or ankle surgery
  • At least 18 years old

You may not qualify if:

  • Unbalanced mental disorder such as schizophrenia or depression
  • Age under 18
  • Does not understand Finnish
  • Undergoing operation other than foot or ankle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Central Finland Central Hospital

Jyväskylä, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Seinäjoki Central Hospital

Seinäjoki, Finland

Location

Peijas Hospital

Vantaa, Finland

Location

MeSH Terms

Conditions

Foot Diseases

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident surgeon

Study Record Dates

First Submitted

January 13, 2018

First Posted

February 23, 2018

Study Start

January 15, 2018

Primary Completion

March 6, 2019

Study Completion

March 14, 2019

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

FI(4)