Hallux valgus (bunions) Musculoskeletal Diseases Hallux valgus (acquired)
Conditions
Interventions
Minimally invasive surgery for hallux valgus (bunions) using the minimally invasive chevron akin (MICA) technique
Sponsors
Apio Implants Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult >16 years 2. Primary hallux valgus operation
Exclusion criteria
Exclusion criteria: Unable to attend for radiographs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. How foot problems impair health-related quality of life, assessed using the Manchester-Oxford Foot Questionnaire (MOXFQ) 2. Health state for mobility, self-care, usual activities, pain/discomfort and anxiety/depression, assessed using the EuroQol-5 Dimensions-5 Level (EQ-5D-5L) Index 3. Global assessment of health assessed using the EuroQol-visual analogue scale (EQ-VAS) 4. Pain intensity measured using Visual Analogue Score (VAS)for pain (VAS-pain) Patient-reported outcomes measures will be collected using questionnaires at pre-op, 2 years and 5 yearly | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic measures of the pre-operative deformity and the post-operative correction and its endurance over time will be measured on standing foot X-rays using digital integrated measurement software at pre-op, 6 weeks and 5 yearly. These will include the distal and proximal intermetatarsal angle (degrees), hallux valgus angle (degrees), sesamoid position (grades 0-3), round sing (presence or absence) and percentage of metatarsal head translation (percentage). | — |
Countries
England, United Kingdom
Outcome results
None listed