Hallux ValgusNCT02915822
COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study
A study testing Minimally Invasive Chevron/Akin osteotomy and Open Scarf/Akin osteotomy in people with Hallux Valgus, run by Northumbria Healthcare NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Minimally Invasive Chevron/Akin osteotomy and Open Scarf/Akin osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Oct 2017to 5 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria NHS Foundation Trust
Newcastle upon Tyne, Northumbria
About this 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.
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
- Conditions
- Hallux Valgus
- Being tested
- Minimally Invasive Chevron/Akin osteotomy, Open Scarf/Akin osteotomy
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Chevron/Akin osteotomyProcedure or surgery
Minimally invasive technique for hallux valgus correction
Open Scarf/Akin osteotomyProcedure or surgery
Open technique for Hallux Valgus correction
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Chevron/Akin osteotomy | Experimental | Minimally invasive technique to surgically correct Hallux Valgus Receives: Procedure: Minimally Invasive Chevron/Akin osteotomy |
| Open Scarf/Akin osteotomy | Active comparator | Open technique to surgically correct Hallux Valgus Receives: Procedure: Open Scarf/Akin osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
Patient reported outcomes assessed by questionnaire
Patient satisfaction, MOXFQ score recorded by questionnaire preoperatively, at 6 months and at 1 year.
Measured: 1 year
MTPJ range of movement in degrees
Measured preoperatively at 6 weeks and 6 months by goniometer
Measured: 6 months
Complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start11 Oct 2017
- Primary completion5 Mar 2023
- Study completion5 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria Healthcare NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajeshkumar Kakwani, Study chair, Northumbria Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915822
- Sponsor's protocol ID
- 181137
- Status last verified
- Jun 2025
- First submitted
- 21 Sep 2016
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study
- ClinicalTrials.gov ID
- NCT02915822
- Acronym / sponsor ID
- 181137
- Conditions
- Hallux Valgus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Northumbria Healthcare NHS Foundation TrustUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Chevron/Akin osteotomy | Experimental | Procedure: Minimally Invasive Chevron/Akin osteotomyMinimally invasive technique to surgically correct Hallux Valgus |
| Open Scarf/Akin osteotomy | Active comparator | Procedure: Open Scarf/Akin osteotomyOpen technique to surgically correct Hallux Valgus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Chevron/Akin osteotomyMinimally invasive technique for hallux valgus correction | Procedure or surgery | Minimally Invasive Chevron/Akin osteotomy |
| Open Scarf/Akin osteotomyOpen technique for Hallux Valgus correction | Procedure or surgery | Open Scarf/Akin osteotomy |
Primary outcome
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.
3 secondary outcomes
Patient reported outcomes assessed by questionnaire
Time frame: 1 year
MTPJ range of movement in degrees
Time frame: 6 months
Complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajeshkumar Kakwani study chair
Northumbria Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Chevron/Akin osteotomy and Open Scarf/Akin osteotomy in people with Hallux Valgus, run by Northumbria Healthcare NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients recruited (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.