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

Northumbria Healthcare NHS Foundation Trust

Status: Completed

Conditions: Hallux Valgus

Treatments: Procedure: Minimally Invasive Chevron/Akin osteotomy; Procedure: Open Scarf/Akin osteotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02915822

181137

Details and patient eligibility

About

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.

Full 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

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

43 participants in 2 patient groups

Minimally Invasive Chevron/Akin osteotomy

Experimental group

Description:

Minimally invasive technique to surgically correct Hallux Valgus

Treatment:

Procedure: Minimally Invasive Chevron/Akin osteotomy

Open Scarf/Akin osteotomy

Active Comparator group

Description:

Open technique to surgically correct Hallux Valgus

Treatment:

Procedure: Open Scarf/Akin osteotomy