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NCT05778916 Clinical Trial

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

Hallux Valgus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05778916
Other study ID # Ostfold Hospital Trust
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 12, 2023
Est. completion date December 1, 2024

Study information
Verified date November 2022
Source Ostfold Hospital Trust
Contact Boel Mikaela Sofie E Hamre
Phone 41273586
Email mikaela.engaras@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 210
Est. completion date December 1, 2024
Est. primary completion date April 12, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 5 year follow up on patients operated for hallux valgus deformity
Clinical and radiological control of patients operated for hallux valgus deformity between 2016-2018.

Locations
Country Name City State
Norway Østfold Hospital Trust Sarpsborg Østfold

Sponsors (1)
Lead Sponsor Collaborator
Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical 5 year outcome Clinical (Manchester-oxford Foot Questionnaire (MOxFQ) Data collection during 2023, completion during 2024
Secondary Clinical VAS 5 year outcome Visual analogue scale (VAS 0-10) Data collection during 2023, completion during 2024
Secondary Clinical Likert scale 5 year outcome Likert scale Data collection during 2023, completion during 2024
Secondary Radiological outcomes Measurement of correction Until 2024
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