COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibi… (NCT02915822) | Clinical Trial Compass
CompletedNot Applicable
COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study
United Kingdom43 participantsStarted 2017-10-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Number of patients recruited
Timeframe: 1 year
Trial details
NCT IDNCT02915822
SponsorNorthumbria Healthcare NHS Foundation Trust