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?

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hallux Valgus Deformity
• Intervention / Treatment: Other: Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus; Other: Operation for mild to moderate hallux valgus

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%. We 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%) we will recruit 120 participants (60 per group).

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marius Molund; Phone Number: 90093988; Email: marius.molund@so-hf.no
• Study Contact Backup: Name: Mikaela E Hamre; Phone Number: +4741273586; Email: mikaela.engaras.hamre@so-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Operation; 60 participants will be operated for mild to moderate hallux valgus deformity	Other: Operation for mild to moderate hallux valgus; 60 participants will receive the traditional operative treatment for the deformity. Participants will be followed for 2 years.
Other: Conservative; 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; 60 participants will receive conservative treatment with orthopedic aid/wide shoe. Participants will be followed for 2 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical result SF-36	Short Form Health Survey (SF-36) (0=worst to 100=best)	2 years
Clinical result VAS	Visual analogue scale (VAS) 0-10 (0=best to 10=worst)	2 years
Clinical result Likert scale	Likert scale 0-5 (0=worst to 5=best)	2 years

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Investigators: Principal Investigator: Marius Molund, Ostfold Hospital Trust

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Congenital Abnormalities; Hallux Valgus; Bunion
• Other Study ID Numbers: 575297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No