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

Hallux Valgus Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06114043
• Other study ID #: 575297
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2030

Study information

• Verified date: January 2024
• Source: Ostfold Hospital Trust
• Contact: Marius Molund
• Phone: 90093988
• Email: marius.molund[@]so-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 2030
• Est. primary completion date: March 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bunion
• Congenital Abnormalities
• Hallux Valgus
• Hallux Valgus Deformity

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ostfold Hospital Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical result VAS	Visual analogue scale (VAS) 0-10 (0=best to 10=worst)	2 years
Secondary	Clinical result SF-36	Short Form Health Survey (SF-36) (0=worst to 100=best)	2 years
Secondary	Clinical result Likert scale	Likert scale 0-5 (0=worst to 5=best)	2 years