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

Not Applicable

• Conditions: Hallux Valgus
• Interventions: Procedure: Open Scarf/Akin osteotomy; Procedure: Minimally Invasive Chevron/Akin osteotomy

• Registration Number: NCT02915822
• Lead Sponsor: Northumbria Healthcare NHS Foundation Trust

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-23
• Study First Posted: 2016-09-27
• Study Start: 2017-10-11
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10
• Primary Completion: 2021-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Scarf/Akin osteotomy	Open Scarf/Akin osteotomy	Open technique to surgically correct Hallux Valgus
Minimally Invasive Chevron/Akin osteotomy	Minimally Invasive Chevron/Akin osteotomy	Minimally invasive technique to surgically correct Hallux Valgus

Primary Outcome Measures

Name	Time	Method
Number of patients recruited	1 year	The number of patients able to be recruited and retained in this feasibility study. This will determine if a larger study can go forward.

Secondary Outcome Measures

Name	Time	Method
Complications	1 year
Patient reported outcomes assessed by questionnaire	1 year	Patient satisfaction, MOXFQ score recorded by questionnaire preoperatively, at 6 months and at 1 year.
MTPJ range of movement in degrees	6 months	Measured preoperatively at 6 weeks and 6 months by goniometer

Trial Locations

Locations (1)

Northumbria NHS Foundation Trust; 🇬🇧 Newcastle upon Tyne, Northumbria, United Kingdom