Estimation of the Minimal Important Difference and Valida... | NCT03444441

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

NCT03444441

Sponsor

Helsinki University Central Hospital

Status

Completed

Last Update Posted

Jan 19, 2021Actual

Enrollment

290Actual

Phase

Not provided

Conditions

Foot Diseases
Ankle Disease

Interventions

Foot or ankle surgery

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2018Actual

Primary Completion Date

Mar 6, 2019Actual

Completion Date

Mar 14, 2019Actual

First Submitted Date

Jan 13, 2018

First Submission Date that Met QC Criteria

Feb 19, 2018

First Posted Date

Feb 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2021

Last Update Posted Date

Jan 19, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jussi Repo, Resident surgeon, Central Finland Hospital DistrictPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Name	Class
Central Finland Hospital District	OTHER
Seinajoki Central Hospital	OTHER
Oulu University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

290Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Foot or ankle surgery	Procedure	Surgery for foot or ankle		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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Minimal important difference	Change from baseline scores at 6 months	Baseline, 6 months

Secondary Outcomes

Measure	Description	Time Frame
Reliability	Change from 6 months scores at 6.5 months	6 months, 6.5 months
General health question	Change from baseline scores at 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Finland Central Hospital		Jyväskylä			Finland
Oulu University Hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005534	Foot Diseases

Ancestor Terms

ID	Term
D009140	Musculoskeletal Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005593	Fracture Fixation, Internal

Ancestor Terms

ID	Term
D005592	Fracture Fixation
D019637	Orthopedic Procedures
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided