Health TrialsbyHealthPanel

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

ConditionHallux Valgus Deformity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOstfold Hospital Trust

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Painful Hallux Valgus deformity

Hallux Valgus Angle <35 degrees

Intermetatarsal angle <15 degrees

18-80 years

Disqualifiers

Advanced osteoarthritis in first metatarsophalangeal joint

Rheumatic diseases

Pregnancy

Drug abuse

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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

    Other intervention

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: OperationOther 1 intervention
Group B: ConservativeOther 1 intervention

Trial outcomes

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)

Time frame
2 years

Secondary outcomes

1

Clinical result VAS

Visual analogue scale (VAS) 0-10 (0=best to 10=worst)

Time frame
2 years
2

Clinical result SF-36

Short Form Health Survey (SF-36) (0=worst to 100=best)

Time frame
2 years
3

Clinical result Likert scale

Likert scale 0-5 (0=worst to 5=best)

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ostfold Hospital Trust

Lead sponsor

Source ClinicalTrials.gov
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