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

NCT02915822 | Completed

• 1 other identifier: 181137
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Valgus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient reported outcomes assessed by questionnaire

  1 year

• MTPJ range of movement in degrees

  6 months

• Complications

  1 year

Study Arms (2)

Minimally Invasive Chevron/Akin osteotomy

EXPERIMENTAL

Minimally invasive technique to surgically correct Hallux Valgus

Procedure: Minimally Invasive Chevron/Akin osteotomy

Open Scarf/Akin osteotomy

ACTIVE COMPARATOR

Open technique to surgically correct Hallux Valgus

Procedure: Open Scarf/Akin osteotomy

Interventions

Minimally Invasive Chevron/Akin osteotomy PROCEDURE

Minimally invasive technique for hallux valgus correction

Minimally Invasive Chevron/Akin osteotomy

Open Scarf/Akin osteotomy PROCEDURE

Open technique for Hallux Valgus correction

Open Scarf/Akin osteotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northumbria Healthcare NHS Foundation Trust: lead

Study Sites (1)

Northumbria NHS Foundation Trust

Newcastle upon Tyne, Northumbria, United Kingdom

Location

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• Rajeshkumar Kakwani

  Northumbria Healthcare NHS Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 27, 2016
• Study Start: October 11, 2017
• Primary Completion: March 5, 2023
• Study Completion: March 5, 2023
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)