5 Year Radiological and Clinical Results From Patients Operated for Hallux Valgus Deformity.
Sponsor
Ostfold Hospital Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05778916
Collaborator
(none)
210
1
19.7
10.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
210 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Radiological Outcome vs.Patient Reported Clinical Outcome 5 Years Post Hallux Valgus Surgery
Anticipated Study Start Date
:
Apr 12, 2023
Anticipated Primary Completion Date
:
Apr 12, 2024
Anticipated Study Completion Date
:
Dec 1, 2024
Outcome Measures
Primary Outcome Measures
- Clinical 5 year outcome [Data collection during 2023, completion during 2024]
Clinical (Manchester-oxford Foot Questionnaire (MOxFQ)
Secondary Outcome Measures
- Clinical VAS 5 year outcome [Data collection during 2023, completion during 2024]
Visual analogue scale (VAS 0-10)
- Clinical Likert scale 5 year outcome [Data collection during 2023, completion during 2024]
Likert scale
- Radiological outcomes [Until 2024]
Measurement of correction
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Østfold Hospital Trust | Sarpsborg | Østfold | Norway | 1714 |
Sponsors and Collaborators
- Ostfold Hospital Trust
Investigators
- Study Director: Marius Molund, MD, phd, Ostfold Hospital Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ostfold Hospital Trust
ClinicalTrials.gov Identifier:
NCT05778916
Other Study ID Numbers:
- Ostfold Hospital Trust
First Posted:
Mar 22, 2023
Last Update Posted:
Mar 22, 2023
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ostfold Hospital Trust
Additional relevant MeSH terms: