Status unknownNCT05778916Updated Mar 22, 2023

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

An observational study in Hallux Valgus, sponsored by Ostfold Hospital Trust. Status unknown at 1 site in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-22.

Sponsored by Ostfold Hospital Trust · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.

Study type: Observational
Model: Cohort
Time perspective: Other
Enrollment: 210
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Hallux Valgus

Browse trials for

Hallux Valgus 157

Keywords

Radiological outcome
Clinical outcome

In context

Hallux Valgus

157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.

This study's planned enrollment of 210 is above the median of 60 across 35 observational studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

Ostfold Hospital Trust is the lead sponsor of 50 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Not able to speak/write/read norwegian language

Study design

Observational model: Cohort
Time perspective: Other
Enrollment: 210 participants (estimated)
Target follow-up: 5 Years
Patient registry: Yes

Interventions

Procedure5 year follow up on patients operated for hallux valgus deformity
Clinical and radiological control of patients operated for hallux valgus deformity between 2016-2018.

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Østfold Hospital Trust
Sarpsborg, Østfold 1714, Norway

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2023; primary completion for Apr 2024, 12 months later.

Of 15 observational studies under Hallux Valgus, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 62. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 28, 2022
First posted: Mar 22, 2023
StartEst.: Apr 12, 2023
Primary completionEst.: Apr 12, 2024
CompletionEst.: Dec 1, 2024
Last update: Mar 22, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05778916
Lead sponsor: Ostfold Hospital Trust
Responsible party: Sponsor
First posted: Mar 22, 2023
Start date: Apr 12, 2023 (estimated)
Primary completion: Apr 12, 2024 (estimated)
Completion: Dec 1, 2024 (estimated)
Last update: Mar 22, 2023

Study contacts

Boel Mikaela Sofie E Hamre

Contact

mikaela.engaras@gmail.com

41273586

Marius Molund

Contact

marius.molund@so-hf.no

90093988

Marius Molund, MD, phd

study director · Ostfold Hospital Trust

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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