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

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02915822
• Other study ID #: 181137
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: October 2022

Study information

• Verified date: March 2021
• Source: Northumbria Healthcare NHS Foundation Trust
• Contact: Deborah Bunn
• Phone: 0044 344 811 8111
• Email: ResearchAndDevelopment[@]northumbria-healthcare.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

Procedure:
• Minimally Invasive Chevron/Akin osteotomy
Minimally invasive technique for hallux valgus correction
• Open Scarf/Akin osteotomy
Open technique for Hallux Valgus correction

Locations

Country	Name	City	State
United Kingdom	Northumbria NHS Foundation Trust	Newcastle upon Tyne	Northumbria

Sponsors (1)

Lead Sponsor	Collaborator
Northumbria Healthcare NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient reported outcomes assessed by questionnaire	Patient satisfaction, MOXFQ score recorded by questionnaire preoperatively, at 6 months and at 1 year.	1 year
Secondary	MTPJ range of movement in degrees	Measured preoperatively at 6 weeks and 6 months by goniometer	6 months
Secondary	Complications		1 year