Clinical Trial: COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study

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 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 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
Sponsor: Northumbria Healthcare NHS Foundation Trust

Current Primary Outcome: Number of patients recruited [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patient reported outcomes assessed by questionnaire [ Time Frame: 1 year ]
    Patient satisfaction, MOXFQ score recorded by questionnaire preoperatively, at 6 months and at 1 year.
  • MTPJ range of movement in degrees [ Time Frame: 6 months ]
    Measured preoperatively at 6 weeks and 6 months by goniometer
  • Complications [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Northumbria Healthcare NHS Foundation Trust

Dates:
Date Received: September 21, 2016
Date Started: January 2017
Date Completion: January 2018
Last Updated: September 23, 2016
Last Verified: September 2016