Clinical trial NCT06114043: Operative Versus Non-operative Treatment for Mild to Moderate Hallux Valgus Deformity
Official title: Randomised Controlled Trial; Is Operative Treatment of Mild to Moderate Hallux Valgus Deformity Superior to Conservative Treatment?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hallux Valgus Deformity
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial investigating patients with painful mild to moderate hallux valgus deformity
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical results MOxFQ
timeFrame: 2 years
Secondary outcomes:
measure: Clinical result VAS
timeFrame: 2 years
measure: Clinical result SF-36
timeFrame: 2 years
measure: Clinical result Likert scale
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Ostfold Hospital Trust
name: Marius Molund
role: PRINCIPAL_INVESTIGATOR
References: