NCT05880407RecruitingNot Applicable
Pilot Study of Percutaneous Correction of Hallux Valgus: Clinical-functional Evaluation of Outcome Randomized Study
Istituto Ortopedico Rizzoli1 site in 1 country40 target enrollmentStarted: February 22, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Visual Analog Score
Study Overview
Brief Summary
This is a pilot study with a randomized controlled design.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients of both sexes with adult hallux valgus with indication for corrective surgical treatment
- •HVA (hallux valgus angle): 20°-40°
- •IMA (intermetatarsal angle): 10°-20°
Exclusion Criteria
- •Patients with instability of the first metatarsophalangeal joint
- •Patients with severe morphostructural alterations or other pathologies in the foot and lower limb
- •patients requiring additional surgical procedures
- •patients with severe vascular and neurological systemic pathologies
- •systemic pathologies that may impair bone consolidation
Arms & Interventions
standard treatment
Active Comparator
SERI osteotomy
Intervention: SERI osteotomy (Procedure)
experimental treatment
Experimental
percutaneous osteotomy according to Chevron
Intervention: percutaneous osteotomy according to Chevron (Procedure)
Outcomes
Primary Outcomes
Visual Analog Score
Time Frame: baseline
pain visual analog assessment
Visual Analog Score
Time Frame: 1 year
pain visual analog assessment
Secondary Outcomes
- American Orhtopaedic Foot and Ankle Society forefoot score(baseline and aftef 1 year)
Investigators
Study Sites (1)
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