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

March 20, 2023 updated by: Ostfold Hospital Trust

Radiological Outcome vs.Patient Reported Clinical Outcome 5 Years Post Hallux Valgus Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
    • Østfold
      • Sarpsborg, Østfold, Norway, 1714
        • Østfold Hospital Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical VAS 5 year outcome
Time Frame: Data collection during 2023, completion during 2024
Visual analogue scale (VAS 0-10)
Data collection during 2023, completion during 2024
Clinical Likert scale 5 year outcome
Time Frame: Data collection during 2023, completion during 2024
Likert scale
Data collection during 2023, completion during 2024
Radiological outcomes
Time Frame: Until 2024
Measurement of correction
Until 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ostfold Hospital Trust

Investigators

  • Study Director: Marius Molund, MD, phd, Ostfold Hospital Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 12, 2023

Primary Completion (Anticipated)

April 12, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ostfold Hospital Trust

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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