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NCT Number: NCT06114043

Operative Versus Non-operative Treatment for Mild to Moderate Hallux Valgus Deformity

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.

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Key information

Conditions

Hallux Valgus Deformity

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Painful Hallux Valgus deformity
  • Hallux Valgus Angle <35 degrees
  • Intermetatarsal angle <15 degrees
  • 18-80 years

Exclusion criteria

  • Advanced osteoarthritis in first metatarsophalangeal joint
  • Rheumatic diseases
  • Pregnancy
  • Drug abuse
  • Severe psychological disorder
  • Lack of compliance
  • Language barrier

Treatment and study plan

Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus

Other

60 participants will receive conservative treatment with orthopedic aid/wide shoe. Participants will be followed for 2 years.

Operation for mild to moderate hallux valgus

Other

60 participants will receive the traditional operative treatment for the deformity. Participants will be followed for 2 years.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Clinical result VAS

    Time frame: 2 years

    Visual analogue scale (VAS) 0-10 (0=best to 10=worst)

  2. Clinical result SF-36

    Time frame: 2 years

    Short Form Health Survey (SF-36) (0=worst to 100=best)

  3. Clinical result Likert scale

    Time frame: 2 years

    Likert scale 0-5 (0=worst to 5=best)

Study contacts

Contact information is provided by the study sponsor or research team.

Marius Molund

CONTACT

[email protected]

90093988

Mikaela E Hamre

CONTACT

[email protected]

+4741273586

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Registry information

Official study title

Randomised Controlled Trial; Is Operative Treatment of Mild to Moderate Hallux Valgus Deformity Superior to Conservative Treatment?

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Nov 2, 2023
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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