Trials / Completed
CompletedNCT02915822
COSMIC Study - Comparing Open Scarf/Akin Osteotomy and Minimally Invasive Chevron/Akin. A Feasibility Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Northumbria Healthcare NHS Foundation Trust · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Minimally Invasive Chevron/Akin osteotomy | Minimally invasive technique for hallux valgus correction |
| PROCEDURE | Open Scarf/Akin osteotomy | Open technique for Hallux Valgus correction |
Timeline
- Start date
- 2017-10-11
- Primary completion
- 2023-03-05
- Completion
- 2023-03-05
- First posted
- 2016-09-27
- Last updated
- 2025-06-18
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02915822. Inclusion in this directory is not an endorsement.