NCT07344077

Comparing Outcomes Using 1 Versus 2 Kirshner Wire Fixation in Patients With Severe Hallux Valgus

Comparison of Radiographic and Functional Outcomes of Minimal Invasive Distal Metatarsal Osteotomy Using 1 Versus 2 Kirshner Wire Fixation in Patients With Severe Hallux Valgus: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Comparing the radiographic and functional outcomes by using a Minimal invasive procedure to treat Hallux Valgus ; Distal linear Metatarsal Osteotomy - 1 Kirshner wire fixation versus two Kirshner wire fixation

Detailed description

This is a randomise controlled trial between two groups patients, which are assigned to two different interventions, undergoing minimal invasive Hallux valgus surgery. 2nd generation of Minimal invasive surgery was selected in hallux valgus surgery due to its availability, cost effectiveness, reduced pain , and the overall simplicity of the operation, providing smaller surgical scars, and less op time , as well as blood loss. this was done by making a osteotomy cut at the first metatarsal neck and placing one intramedullary Kirshner wire through the first metatarsal joint. However the stability and the complication of this technique still remains - such as recurrence, K wire loosening, pin tract infection and malunion. We believe that by adding another intramedullary Kirshner wire to fix the first metatarsal accoss the Metatarsophalangeal joint, the stability of the construct will improve and maintain a reduced hallux valgus angle ,and reduce the rate of complications , ultimately improving pain and functional outcome of the patient. the participants were purposely randomized, and divided into two equal groups with 25 cases. the control group recieved a fixation with one Kirshner wire (standard) and the experimental group recieved a fixation with two Kirshner wire. Data were analyzed using paired T test , wilcoxon signed-rank test and chi squared test

Conditions

• Hallux Valgus Correction
• Hallux Valgus
• Hallux Valgus Deformity
• Minimal Invasive Surgery

Interventions

Type	Name	Description
PROCEDURE	2 Kirshner wire fixation	additional Kirshner wire fixation of first metatarsal bone

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-01-01
• Completion: 2026-05-01
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: Thailand