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Comparing open and minimally invasive osteotomy for the surgical correction of bunions - a feasibility study

COSMIC study - Comparing Open Scarf osteotomy and Minimally Invasive Chevron for Hallux Valgus Correction. A Feasibility Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17635882
Enrollment
100
Registered
2016-11-02
Start date
2017-09-13
Completion date
Unknown
Last updated
2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus Musculoskeletal Diseases Hallux Valgus

Interventions

Participants will be identified in outpatient clinics and offered to participate in the study. Pre-operative patient questionnaires will be recorded. The patients will then be randomized into one of t

Sponsors

Northumbria Healthcare NHS Foundation Trust,
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients over 18 years of age 2. Patients with Hallux valgus deformity suitable for treatment by both Open Scarf/Akin and MICA procedures 3. Patients with no significant co-morbidities that would increase their risk of procedure 4. Patients able to understand and complete questionnaires 5. Patients with the capacity to provide informed consent 6. Patients who have in addition to Hallux Valgus deformity, have lesser toe deformities requiring correction distal to the metatarsal phalangeal joint at time of procedure 7. Patients without significant other mid foot or hind foot pathology

Exclusion criteria

Exclusion criteria: 1. Patients under 18 years of age 2. Patients with severity of Hallux valgus deformity necessitating Open procedure 3. Patients with significant co-morbidities that would increase the risk of surgery 4. Patients unable to understand or complete questionnaires 5. Patients without the capacity to provide informed consent 6. Patients with additional deformity requiring additional procedures proximal to the metatarsal phalangeal joint

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is feasibility of the study. This will be assessed via the number of patients able to be recruited into the study. Retention of those patients throughout the study and from analyzing the initial data, discussed in secondary outcome measures, to assess if any concerns are raised during the study period.

Secondary

MeasureTime frame
1. Patient reported outcomes - This outcome measure will be the patient reported outcomes obtained by patient questionnaire. MOXFQ-index will be obtained from patients’ questionnaires pre operatively for baseline and subsequently at 6 and 12 months for both groups 2. Range of movement of the 1st MTPJ will be measured with a goniometer preoperatively and at Outpatient follow up and 6 weeks and 6 months. The differences between the two groups will be statistically analyzed 3. Adverse Events are recorded through clinical observations throughout the post-operative period

Countries

United Kingdom

Contacts

Public ContactDeborah Bunn

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026