NCT05778916

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

November 28, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

April 12, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 22, 2023

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

November 28, 2022

Last Update Submit

March 20, 2023

Conditions

Hallux Valgus

Keywords

Radiological outcomeClinical outcome

Outcome Measures

Primary Outcomes (1)

  • Clinical 5 year outcome

    Clinical (Manchester-oxford Foot Questionnaire (MOxFQ)

    Data collection during 2023, completion during 2024

Secondary Outcomes (3)

  • Clinical VAS 5 year outcome

    Data collection during 2023, completion during 2024

  • Clinical Likert scale 5 year outcome

    Data collection during 2023, completion during 2024

  • Radiological outcomes

    Until 2024

Interventions

5 year follow up on patients operated for hallux valgus deformityPROCEDURE

Clinical and radiological control of patients operated for hallux valgus deformity between 2016-2018.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Not able to speak/write/read norwegian language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Østfold Hospital Trust

Sarpsborg, Østfold fylke, 1714, Norway

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Study Officials

  • Marius Molund, MD, phd

    Ostfold Hospital Trust

    STUDY DIRECTOR

Central Study Contacts

Boel Mikaela Sofie E Hamre

CONTACT

41273586mikaela.engaras@gmail.com

Marius Molund

CONTACT

90093988marius.molund@so-hf.no

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2022

First Posted

March 22, 2023

Study Start

April 12, 2023

Primary Completion

April 12, 2024

Study Completion

December 1, 2024

Last Updated

March 22, 2023

Record last verified: 2022-11

Locations

NO(1)