Foot DiseasesNCT03444441
Estimation of the Minimal Important Difference and Validation of Foot and Ankle Instruments
An observational study of Foot Diseases and Ankle Disease, run by Helsinki University Central Hospital at 4 sites in Finland.
Trial summary
The present study investigates the minimal important change and validity of foot and ankle measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Diseases, Ankle Disease
- What is being tested?
- Foot or ankle surgery
- Type of treatment
- Surgery or procedure
- How many people
- 290 participants
- Where
- 4 sitesFinland
- Study dates
- 15 Jan 2018to 14 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study recruits adult patients who are undergoing foot or ankle surgery for various reasons.
Who may be able to join
- Full understanding of Finnish language
- Undergoing foot or ankle surgery
- At least 18 years old
Who cannot join
- Unbalanced mental disorder such as schizophrenia or depression
- Age under 18
- Does not understand Finnish
- Undergoing operation other than foot or ankle
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
Central Finland Central Hospital
Jyväskylä
Oulu University Hospital
Oulu
Seinäjoki Central Hospital
Seinäjoki
Peijas Hospital
Vantaa
About this study
Official title: Estimation of the Minimal Important Difference and Validation of Finnish Versions of Foot and Ankle Patient-reported Outcome Instruments
The present study investigates the minimal important change and validity of foot and ankle measures.
Read the detailed 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.
- Conditions
- Foot Diseases, Ankle Disease
- Being tested
- Foot or ankle surgery
- Keywords
- Foot, Ankle, Finnish, Validation, FAOS, EFAS, LEFS, FAAM, VAS-FA, MOxFA
- Medical subject headings
- Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot or ankle surgeryProcedure or surgery
Also called correction forefoot, correction midfoot, correction hindfoot, correction ankle
Surgery for foot or ankle
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal important difference
Change from baseline scores at 6 months
Measured: Baseline, 6 months
Secondary outcomes (6)
Reliability
Change from 6 months scores at 6.5 months
Measured: 6 months, 6.5 months
General health question
Change from baseline scores at 6 months
Measured: Baseline, 6 months
General health question
Change from baseline scores at 6 months
Measured: 6 months, 6.5 months
Global assessment scale
Change from baseline scores at 6 months
Measured: 6 months
Validity
Baseline scores
Measured: Baseline
Validity
6 months scores
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start15 Jan 2018
- Primary completion6 Mar 2019
- Study completion14 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot DiseasesStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Central Finland Hospital District, Seinajoki Central Hospital, Oulu University Hospital
- Responsible party
- Principal investigator, Jussi Repo, Central Finland Hospital District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444441
- Sponsor's protocol ID
- FA2018
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2018
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Minimal Important Difference and Validation of Finnish Versions of Foot and Ankle Patient-reported Outcome Instruments
- ClinicalTrials.gov ID
- NCT03444441
- Acronym / sponsor ID
- FA2018
- Conditions
- Foot Diseases, Ankle Disease
- Keywords
- Foot, Ankle, Finnish, Validation, FAOS, EFAS, LEFS, FAAM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Central Finland Hospital District, Seinajoki Central Hospital, Oulu University Hospital
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study investigates the minimal important change and validity of foot and ankle measures.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study recruits adult patients who are undergoing foot or ankle surgery for various reasons.
Key inclusion criteria (3 listed)
- Full understanding of Finnish language
- Undergoing foot or ankle surgery
- At least 18 years old
Key exclusion criteria (4 listed)
- Unbalanced mental disorder such as schizophrenia or depression
- Age under 18
- Does not understand Finnish
- Undergoing operation other than foot or ankle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot or ankle surgeryAlso: correction forefoot, correction midfoot, correction hindfoot, correction ankleSurgery for foot or ankle | Procedure or surgery | – |
Primary outcome
Minimal important difference
Time frame: Baseline, 6 months
Change from baseline scores at 6 months
6 secondary outcomes
Reliability
Time frame: 6 months, 6.5 months
General health question
Time frame: Baseline, 6 months
General health question
Time frame: 6 months, 6.5 months
Global assessment scale
Time frame: 6 months
Validity
Time frame: Baseline
Validity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Diseases and Ankle Disease, run by Helsinki University Central Hospital at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal important difference (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.