COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study
Launched by NORTHUMBRIA HEALTHCARE NHS FOUNDATION TRUST · Sep 23, 2016
Trial Information
Current as of May 14, 2025
Unknown status
Keywords
ClinConnect Summary
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 tech...
Gender
ALL
Eligibility criteria
- 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.
About Northumbria Healthcare Nhs Foundation Trust
Northumbria Healthcare NHS Foundation Trust is a leading healthcare provider in the North East of England, renowned for its commitment to delivering high-quality patient care and advancing medical research. As a prominent clinical trial sponsor, the Trust actively engages in innovative research initiatives aimed at improving health outcomes and enhancing treatment options across a range of medical disciplines. With a robust framework for clinical governance and a multidisciplinary team of experienced professionals, Northumbria Healthcare focuses on fostering collaborative partnerships to drive evidence-based practices and contribute to the broader scientific community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Newcastle Upon Tyne, Northumbria, United Kingdom
Patients applied
Trial Officials
Rajeshkumar Kakwani
Study Chair
Northumbria Healthcare NHS Trust
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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