Hallux Valgus DeformityNCT06114043
Operative Versus Non-operative Treatment for Mild to Moderate Hallux Valgus Deformity
A study testing Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus and Operation for mild to moderate hallux valgus in people with Hallux Valgus Deformity, run by Ostfold Hospital Trust at 1 site in Norway.
Trial summary
The goal of this randomized controlled trial is to investigate operative treatment versus conservative treatment in participants suffering from mild to moderate hallux valgus deformity. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus Deformity
- What is being tested?
- Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus and Operation for mild to moderate hallux valgus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2025to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Painful Hallux Valgus deformity
- Hallux Valgus Angle <35 degrees
- Intermetatarsal angle <15 degrees
- 18-80 years
Who cannot join
- Advanced osteoarthritis in first metatarsophalangeal joint
- Rheumatic diseases
- Pregnancy
- Drug abuse
- Severe psychological disorder
- Lack of compliance
- Language barrier
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Østfold Hospital Trust
Sarpsborg, 1714
Marius Molund, MD PhD, +4790093988, mariusmolund@hotmail.com
Martin O Riiser, MD PhD candidate, +4797146230, riiser.martin@gmail.com
About this study
Official title: Randomised Controlled Trial; Is Operative Treatment of Mild to Moderate Hallux Valgus Deformity Superior to Conservative Treatment?
The goal of this randomized controlled trial is to investigate operative treatment versus conservative treatment in participants suffering from mild to moderate hallux valgus deformity. The main question it aims to answer are; Is surgery superior to conservative treatment?
The participants will be randomized in to two groups, operative and conservative group.
Investigators will compare the groups measuring the clinical results using the patient-reported outcome measure (PROM) Manchester-Oxford Foot Questionnaire (MOxFQ), Visual analog scale (VAS), likert scale 0-5. Participants will be observed for a period og two years.
Read the detailed description
Randomized controlled trial (RCT) investigating the patient reported outcome after operative or conservative treatment in mild to moderate hallux valgus deformity. In this RCT study participants will be divided into operative group, non-operative group where the treatment will be orthopedic aids/wide shoes. The participants will be evaluated 6 months, 1 year and 2 years after starting the treatment. The clinical results will be evaluated using patient reported outcome measures (PROMs).
Primary aim: Investigating the clinical result by PROM (Manchester Oxford Foot Questionnaire)
Secondary aim: Investigating the radiological results according to newer and traditional parameters. Operative group -correction achieved, residual rate. Conservative group -progression of deformity.
Statistical power calculations have been made within the research group. Calculations are based on the main outcome MOxFQ, with the power of 80 and confidence interval 95%. The investigators concluded that a sample size of 49 participants will be needed to perform a regression analysis. To account for loss to follow-up (estimated 20%),120 participants (60 per group) will be recruited.
- Conditions
- Hallux Valgus Deformity
- Being tested
- Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus, Operation for mild to moderate hallux valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgusOther
60 participants will receive conservative treatment with orthopedic aid/wide shoe. Participants will be followed for 2 years.
Operation for mild to moderate hallux valgusOther
60 participants will receive the traditional operative treatment for the deformity. Participants will be followed for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Operation | Other | 60 participants will be operated for mild to moderate hallux valgus deformity Receives: Other: Operation for mild to moderate hallux valgus |
| Conservative | Other | 60 participants will be treated conservatively with a wide shoe Receives: Other: Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical results MOxFQ
Manchester oxford foot questionnaire (MOxFQ) (Raw scores can be converted to a 0-100 metric where 100=most severe)
Measured: 2 years
Secondary outcomes (3)
Clinical result VAS
Visual analogue scale (VAS) 0-10 (0=best to 10=worst)
Measured: 2 years
Clinical result SF-36
Short Form Health Survey (SF-36) (0=worst to 100=best)
Measured: 2 years
Clinical result Likert scale
Likert scale 0-5 (0=worst to 5=best)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jun 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Valgus DeformityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial investigating patients with painful mild to moderate hallux valgus deformity
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Molund, Ostfold Hospital Trust
- Investigators
- Marius Molund, Principal investigator, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114043
- Sponsor's protocol ID
- 575297
- Status last verified
- Jul 2025
- First submitted
- 20 Mar 2023
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial; Is Operative Treatment of Mild to Moderate Hallux Valgus Deformity Superior to Conservative Treatment?
- ClinicalTrials.gov ID
- NCT06114043
- Acronym / sponsor ID
- 575297
- Conditions
- Hallux Valgus Deformity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 2 Nov 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.
The goal of this randomized controlled trial is to investigate operative treatment versus conservative treatment in participants suffering from mild to moderate hallux valgus deformity. The main question it aims to answer are; Is surgery superior to conservative treatment?
The participants will be randomized in to two groups, operative and conservative group.
Investigators will compare the groups measuring the clinical results using the patient-reported outcome measure (PROM) Manchester-Oxford Foot Questionnaire (MOxFQ), Visual analog scale (VAS), likert scale 0-5. Participants will be observed for a period og two years.
Detailed description
Randomized controlled trial (RCT) investigating the patient reported outcome after operative or conservative treatment in mild to moderate hallux valgus deformity. In this RCT study participants will be divided into operative group, non-operative group where the treatment will be orthopedic aids/wide shoes. The participants will be evaluated 6 months, 1 year and 2 years after starting the treatment. The clinical results will be evaluated using patient reported outcome measures (PROMs).
Primary aim: Investigating the clinical result by PROM (Manchester Oxford Foot Questionnaire)
Secondary aim: Investigating the radiological results according to newer and traditional parameters. Operative group -correction achieved, residual rate. Conservative group -progression of deformity.
Statistical power calculations have been made within the research group. Calculations are based on the main outcome MOxFQ, with the power of 80 and confidence interval 95%. The investigators concluded that a sample size of 49 participants will be needed to perform a regression analysis. To account for loss to follow-up (estimated 20%),120 participants (60 per group) will be recruited.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial investigating patients with painful mild to moderate hallux valgus deformity
| Arm | Type | Receives |
|---|---|---|
| Operation | Other | Other: Operation for mild to moderate hallux valgus60 participants will be operated for mild to moderate hallux valgus deformity |
| Conservative | Other | Other: Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus60 participants will be treated conservatively with a wide shoe |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Painful Hallux Valgus deformity
- Hallux Valgus Angle <35 degrees
- Intermetatarsal angle <15 degrees
- 18-80 years
Key exclusion criteria (7 listed)
- Advanced osteoarthritis in first metatarsophalangeal joint
- Rheumatic diseases
- Pregnancy
- Drug abuse
- Severe psychological disorder
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 |
|---|---|---|
| Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus60 participants will receive conservative treatment with orthopedic aid/wide shoe. Participants will be followed for 2 years. | Other | Conservative |
| Operation for mild to moderate hallux valgus60 participants will receive the traditional operative treatment for the deformity. Participants will be followed for 2 years. | Other | Operation |
Primary outcome
Clinical results MOxFQ
Time frame: 2 years
Manchester oxford foot questionnaire (MOxFQ) (Raw scores can be converted to a 0-100 metric where 100=most severe)
3 secondary outcomes
Clinical result VAS
Time frame: 2 years
Clinical result SF-36
Time frame: 2 years
Clinical result Likert scale
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Marius Molund principal investigator
Ostfold Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus and Operation for mild to moderate hallux valgus in people with Hallux Valgus Deformity, 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marius Molund (90093988, marius.molund@so-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical results MOxFQ (time frame: 2 years). 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 3 Aug 2025.