COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study

Study Overview
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Brief Summary
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The aim of this study is to assess the feasibility of conducting a study to compare the patient recorded and clinical outcomes for the surgical management of Hallux Valgus correction. A prospective trial will randomise the patients into two groups - Open Scarf/Akin osteotomy and Minimally Invasive Chevron/Akin osteotomy.

Detailed Description
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This study will assess the feasibility of a prospective trial that would randomise the patients into two groups for surgical correction of Hallux Valgus - Open Scarf/Akin osteotomy and Minimally Invasive Chevron/Akin osteotomy. Patients will complete a validated questionnaire (Manchester Oxford Foot questionnaire) preoperatively and post operatively at 6 months and 1 year. Range of motion of the Great Toe Metatarsal Phalangeal Joint will also be measured by goniometer. This study will assess the ability to recruit and retain patients and thus determine if a study comparing the surgical techniques would be feasible. In addition, for data collected statistical differences of the change in patient reported outcomes, range of motion between the two groups will be calculated with a significance level of p<0.05. This study will assess if a larger study comparing minimally invasive to open Hallux Valgus correction would be able to be performed

Official Title
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COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study

Conditions
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Hallux Valgus

Intervention / Treatment
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* Procedure: Minimally Invasive Chevron/Akin osteotomy
* Procedure: Open Scarf/Akin osteotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age. Patients with Hallux valgus deformity suitable for treatment by both Open Scarf/Akin and MICA procedures. Patients with no significant co-morbidities that would increase their risk of procedure. Patients able to understand and complete questionnaires. Patients with the capacity to provide informed consent. Patients who have, in addition to Hallux Valgus Deformity, lesser toe deformities requiring correction distal to the metatarsal phalangeal joint at time of procedure. Patients without significant other mid foot or hind foot pathology Exclusion Criteria: Patients under 18 years of age Patients with severity of Hallux valgus deformity necessitating Open procedure Patients with significant co-morbidities that would increase the risk of surgery Patients unable to understand or complete questionnaires. Patients without the capacity to provide informed consent. Patients with additional deformity requiring additional procedures proximal to the metatarsal phalangeal joint.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally Invasive Chevron/Akin osteotomy<br>Minimally invasive technique to surgically correct Hallux Valgus | Procedure: Minimally Invasive Chevron/Akin osteotomy<br>* Minimally invasive technique for hallux valgus correction<br>|
| Active Comparator: Open Scarf/Akin osteotomy<br>Open technique to surgically correct Hallux Valgus | Procedure: Open Scarf/Akin osteotomy<br>* Open technique for Hallux Valgus correction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients recruited | The number of patients able to be recruited and retained in this feasibility study. This will determine if a larger study can go forward. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes assessed by questionnaire | Patient satisfaction, MOXFQ score recorded by questionnaire preoperatively, at 6 months and at 1 year. | 1 year | 
| MTPJ range of movement in degrees | Measured preoperatively at 6 weeks and 6 months by goniometer | 6 months | 
| Complications |  | 1 year |