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

Ostfold Hospital Trust

Status: Enrolling

Conditions: Hallux Valgus Deformity

Treatments: Other: Operation for mild to moderate hallux valgus; Other: Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus

Study type: Interventional

Funder types: Other

Identifiers

NCT06114043

575297

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Operation

Other group

Description:

60 participants will be operated for mild to moderate hallux valgus deformity

Treatment:

Other: Operation for mild to moderate hallux valgus

Conservative

Other group

Description:

60 participants will be treated conservatively with a wide shoe

Treatment:

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