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NCT Number: NCT02915822

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northumbria NHS Foundation Trust

Newcastle upon Tyne, Northumbria, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minimally Invasive Chevron/Akin osteotomy

Procedure

Minimally invasive technique for hallux valgus correction

Open Scarf/Akin osteotomy

Procedure

Open technique for Hallux Valgus correction

Primary outcomes

  1. Number of patients recruited

    Time frame: 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 outcomes

  1. Patient reported outcomes assessed by questionnaire

    Time frame: 1 year

    Patient satisfaction, MOXFQ score recorded by questionnaire preoperatively, at 6 months and at 1 year.

  2. MTPJ range of movement in degrees

    Time frame: 6 months

    Measured preoperatively at 6 weeks and 6 months by goniometer

  3. Complications

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Northumbria Healthcare NHS Foundation Trust

Other

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2016
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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