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

Sponsor

Ostfold Hospital Trust (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06114043

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this randomized controlled trial is to investigate operative treatment versus conservative treatment in patients 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, likert scale 0-10. Participants will be observed for a period og two years.

Condition or Disease	Intervention/Treatment	Phase
Hallux Valgus Deformity	Other: Conservative treatment with orthopedic aid/wide shoe for participants with mild to moderate hallux valgus Other: Operation for mild to moderate hallux valgus	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised controlled trial investigating patients with painful mild to moderate hallux valgus deformityRandomised controlled trial investigating patients with painful mild to moderate hallux valgus deformity

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jan 1, 2028

Anticipated Study Completion Date :

Jan 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Other: Operation 60 patients 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. Partipants will be followed for 2 years.
Other: Conservative 60 patients 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.

Arm

Intervention/Treatment

Other: Operation

60 patients 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. Partipants will be followed for 2 years.

Other: Conservative

60 patients 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.

Outcome Measures

Primary Outcome Measures

Clinical results MOxFQ [2 years]
Manchester oxford foot questionnaire (MOxFQ) (Raw scores can be converted to a 0-100 metric where 100=most severe)

Secondary Outcome Measures

Clinical result VAS [2 years]
Visual analogue scale (VAS) 0-10
Clinical result SF-36 [2 years]
Short Form Health Survey (SF-36) (0=worst to 100=best)
Clinical result Likert scale [2 years]
Likert scale 0-10

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ostfold Hospital Trust

Investigators

Principal Investigator: Marius Molund, Ostfold Hospital Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marius Molund, MD, phd, head of foot & ankle department Ostfold hospital trust, Ostfold Hospital Trust

ClinicalTrials.gov Identifier:

NCT06114043

Other Study ID Numbers:

575297

First Posted:

Nov 2, 2023

Last Update Posted:

Nov 2, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hallux Valgus

Bunion

Congenital Abnormalities

Study Results

No Results Posted as of Nov 2, 2023