5 Year Radiological and Clinical Results From Patients Op... | NCT05778916

Studies
5 Year Radiological and Clinical Results From Patients Operated for Hallux Valgus Deformity.

NCT05778916

Sponsor

Ostfold Hospital Trust

Status

Unknown status

Last Update Posted

Mar 22, 2023Actual

Enrollment

210Estimated

Phase

Not provided

Conditions

Hallux Valgus

Interventions

5 year follow up on patients operated for hallux valgus deformity

Countries

Norway

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

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2023Estimated

Primary Completion Date

Apr 12, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Nov 28, 2022

First Submission Date that Met QC Criteria

Mar 20, 2023

First Posted Date

Mar 22, 2023Actual

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

Mar 20, 2023

Last Update Posted Date

Mar 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Retrospective study of patients operated for hallux valgus deformity at our hospital (ostfold hospital trust) 5 years ago. Patients will be clinically examined, a weighted radiograph of the foot (traditional and newer parameters will be evaluated) and patient reported outcome measures (PROM) scores will be collected.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

210Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
5 year follow up on patients operated for hallux valgus deformity	Procedure	Clinical and radiological control of patients operated for hallux valgus deformity between 2016-2018.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical 5 year outcome	Clinical (Manchester-oxford Foot Questionnaire (MOxFQ)	Data collection during 2023, completion during 2024

Secondary Outcomes

Measure	Description	Time Frame
Clinical VAS 5 year outcome	Visual analogue scale (VAS 0-10)	Data collection during 2023, completion during 2024
Clinical Likert scale 5 year outcome	Likert scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients (18-80 years at time of surgery) operated for hallux valgus deformity at ostfold hospital trust 2016-2018

Exclusion Criteria:

Not able to speak/write/read norwegian language

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Norwegian speaking men and women operated for hallux valgus deformity at Ostfold hospital trust in the years 2016-2018.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Boel Mikaela Sofie E Hamre	Contact	41273586		mikaela.engaras@gmail.com
Marius Molund	Contact	90093988		marius.molund@so-hf.no

Overall Officials

Name	Affiliation	Role
Marius Molund, MD, phd	Ostfold Hospital Trust	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Østfold Hospital Trust		Sarpsborg	Østfold fylke	1714	Norway

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
D006215	Hallux Valgus

Ancestor Terms

ID	Term
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided