RecruitingNot ApplicableNCT06114043

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

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


Sponsor

Ostfold Hospital Trust

Enrollment

120 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • Painful Hallux Valgus deformity
  • Hallux Valgus Angle \<35 degrees
  • Intermetatarsal angle \<15 degrees
  • years

Exclusion Criteria7

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

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Interventions

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

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

OTHEROperation for mild to moderate hallux valgus

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


Locations(1)

Østfold Hospital Trust

Sarpsborg, Norway

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NCT06114043


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