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

NCT06114043 | Recruiting

• 1 other identifier: 575297
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Valgus Deformity

Outcome Measures

Primary Outcomes (1)

• Clinical results MOxFQ

  Manchester oxford foot questionnaire (MOxFQ) (Raw scores can be converted to a 0-100 metric where 100=most severe)

  2 years

Secondary Outcomes (3)

• Clinical result VAS

  2 years

• Clinical result SF-36

  2 years

• Clinical result Likert scale

  2 years

Study Arms (2)

Operation

OTHER

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

Other: Operation for mild to moderate hallux valgus

Conservative

OTHER

60 participants will be treated conservatively with a wide shoe

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

Interventions

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.

Conservative

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.

Operation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ostfold Hospital Trust: lead

Study Sites (1)

Østfold Hospital Trust

Sarpsborg, 1714, Norway

RECRUITING

MeSH Terms

Interventions

Conservative Treatment; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Marius Molund

  Ostfold Hospital Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marius Molund

CONTACT

90093988; marius.molund@so-hf.no

Mikaela E Hamre

CONTACT

+4741273586; mikaela.engaras.hamre@so-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, phd, head of foot & ankle department Ostfold hospital trust

Model Details: Randomised controlled trial investigating patients with painful mild to moderate hallux valgus deformity

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: November 2, 2023
• Study Start: June 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)