Clinical trial NCT02915822: COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study
Official title: COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Lead sponsor: Northumbria Healthcare NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

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.

Primary outcomes:
measure: Number of patients recruited
timeFrame: 1 year
Secondary outcomes:
measure: Patient reported outcomes assessed by questionnaire
timeFrame: 1 year
measure: MTPJ range of movement in degrees
timeFrame: 6 months
measure: Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria NHS Foundation Trust
state: Northumbria
Study officials:
affiliation: Northumbria Healthcare NHS Trust
name: Rajeshkumar Kakwani
role: STUDY_CHAIR
References: