Hallux ValgusNCT05778916
5 Year Radiological and Clinical Results From Patients Operated for Hallux Valgus Deformity.
An observational study of Hallux Valgus, run by Ostfold Hospital Trust at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- 5 year follow up on patients operated for hallux valgus deformity
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteNorway
- Study dates
- 12 Apr 2023to 1 Dec 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Norwegian speaking men and women operated for hallux valgus deformity at Ostfold hospital trust in the years 2016-2018.
Who may be able to join
- All patients (18-80 years at time of surgery) operated for hallux valgus deformity at ostfold hospital trust 2016-2018
Who cannot join
- Not able to speak/write/read norwegian language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hallux Valgus
- Being tested
- 5 year follow up on patients operated for hallux valgus deformity
- Keywords
- Radiological outcome, Clinical outcome
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 year follow up on patients operated for hallux valgus deformityProcedure or surgery
Clinical and radiological control of patients operated for hallux valgus deformity between 2016-2018.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical 5 year outcome
Clinical (Manchester-oxford Foot Questionnaire (MOxFQ)
Measured: Data collection during 2023, completion during 2024
Secondary outcomes (3)
Clinical VAS 5 year outcome
Visual analogue scale (VAS 0-10)
Measured: Data collection during 2023, completion during 2024
Clinical Likert scale 5 year outcome
Likert scale
Measured: Data collection during 2023, completion during 2024
Radiological outcomes
Measurement of correction
Measured: Until 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start12 Apr 2023 (estimated)
- Primary completion12 Apr 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 210 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marius Molund, MD, phd, Study director, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778916
- Sponsor's protocol ID
- Ostfold Hospital Trust
- Status last verified
- Nov 2022
- First submitted
- 28 Nov 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Outcome vs.Patient Reported Clinical Outcome 5 Years Post Hallux Valgus Surgery
- ClinicalTrials.gov ID
- NCT05778916
- Acronym / sponsor ID
- Ostfold Hospital Trust
- Conditions
- Hallux Valgus
- Keywords
- Radiological outcome, Clinical outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- 12 Apr 2023 (estimated)
- Primary completion
- 12 Apr 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Norwegian speaking men and women operated for hallux valgus deformity at Ostfold hospital trust in the years 2016-2018.
Key inclusion criteria (1 listed)
- All patients (18-80 years at time of surgery) operated for hallux valgus deformity at ostfold hospital trust 2016-2018
Key exclusion criteria (1 listed)
- Not able to speak/write/read norwegian language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 year follow up on patients operated for hallux valgus deformityClinical and radiological control of patients operated for hallux valgus deformity between 2016-2018. | Procedure or surgery | – |
Primary outcome
Clinical 5 year outcome
Time frame: Data collection during 2023, completion during 2024
Clinical (Manchester-oxford Foot Questionnaire (MOxFQ)
3 secondary outcomes
Clinical VAS 5 year outcome
Time frame: Data collection during 2023, completion during 2024
Clinical Likert scale 5 year outcome
Time frame: Data collection during 2023, completion during 2024
Radiological outcomes
Time frame: Until 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marius Molund, MD, phd study director
Ostfold Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hallux Valgus, run by Ostfold Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boel Mikaela Sofie E Hamre (41273586, mikaela.engaras@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical 5 year outcome (time frame: Data collection during 2023, completion during 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.