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CompletedNCT02915822Updated Jun 18, 2025

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

An interventional study of Minimally Invasive Chevron/Akin osteotomy and Open Scarf/Akin osteotomy in Hallux Valgus, sponsored by Northumbria Healthcare NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by Northumbria Healthcare NHS Foundation Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Hallux Valgus

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03

In context

Hallux Valgus

144 studies on the registry are indexed under Hallux Valgus; 31 are open to participants now.

This study's enrollment of 43 is below the median of 56 across 106 interventional studies indexed under Hallux Valgus.

Browse Hallux Valgus studies →

Lead sponsor

Northumbria Healthcare NHS Foundation Trust is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Minimally Invasive Chevron/Akin osteotomy

    Minimally invasive technique to surgically correct Hallux Valgus

    Procedure: Minimally Invasive Chevron/Akin osteotomy

  • Active comparator
    Open Scarf/Akin osteotomy

    Open technique to surgically correct Hallux Valgus

    Procedure: Open Scarf/Akin osteotomy

Interventions

  • ProcedureMinimally Invasive Chevron/Akin osteotomy

    Minimally invasive technique for hallux valgus correction

  • ProcedureOpen Scarf/Akin osteotomy

    Open technique for Hallux Valgus correction

06

What researchers measure

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.

    Time frame: 1 year

Secondary outcomes

  1. Patient reported outcomes assessed by questionnaire

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

    Time frame: 1 year

  2. MTPJ range of movement in degrees

    Measured preoperatively at 6 weeks and 6 months by goniometer

    Time frame: 6 months

  3. Complications

    Time frame: 1 year

07

Study locations

1 site
  • Northumbria NHS Foundation Trust
    Newcastle upon Tyne, Northumbria, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02915822
Lead sponsor
Northumbria Healthcare NHS Foundation Trust
Responsible party
Sponsor
First posted
Sep 27, 2016
Start date
Oct 11, 2017
Primary completion
Mar 5, 2023
Completion
Mar 5, 2023
Last update
Jun 18, 2025

Study contacts

Rajeshkumar Kakwani
study chair · Northumbria Healthcare NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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