COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Number of patients recruited
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Number of patients recruited
时间窗: 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.
次要结局
- Complications(1 year)
- Patient reported outcomes assessed by questionnaire(1 year)
- MTPJ range of movement in degrees(6 months)