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

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.

Study Overview

• Status: Recruiting
• Conditions: Hallux Valgus
• Intervention / Treatment: Procedure: Minimally Invasive Chevron/Akin osteotomy; Procedure: Open Scarf/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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deborah Bunn; Phone Number: 4548 0044 344 811 8111; Email: ResearchAndDevelopment@northumbria-healthcare.nhs.uk

Study Locations

• United Kingdom
  • Northumbria
    • Newcastle upon Tyne, Northumbria, United Kingdom
      • Recruiting
      • Northumbria NHS Foundation Trust
      • Contact: Deborah Bunn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Minimally Invasive Chevron/Akin osteotomy; Minimally invasive technique to surgically correct Hallux Valgus	Procedure: Minimally Invasive Chevron/Akin osteotomy; Minimally invasive technique for hallux valgus correction
ACTIVE_COMPARATOR: Open Scarf/Akin osteotomy; Open technique to surgically correct Hallux Valgus	Procedure: Open Scarf/Akin osteotomy; Open technique for Hallux Valgus correction

What is the study measuring?

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
Complications		1 year
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

Collaborators and Investigators

• Sponsor: Northumbria Healthcare NHS Foundation Trust
• Investigators: Study Chair: Rajeshkumar Kakwani, Northumbria Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 11, 2017
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (ESTIMATE): September 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hallux Valgus
• Other Study ID Numbers: 181137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No