Идёт набор NCT07344077

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

Без фазы С лечением Hallux Valgus Correction Hallux Valgus Hallux Valgus Deformity Minimal Invasive Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: 2 Kirshner wire fixation.
Кому может быть актуально: Состояния в реестре: Hallux Valgus Correction, Hallux Valgus, Hallux Valgus Deformity, Minimal Invasive Surgery. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Таиланд
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

Процедура 2 Kirshner wire fixation
additional Kirshner wire fixation of first metatarsal bone

Первичные конечные точки

Hallux Valgus Angle ( HVA ) [Срок оценки: baseline, 2 week , 1 month , 2 month, 4 month , 8 month, 12 month]

Критерии участия

Критерии включения

age 18-60 year
pain along medial surface of first MTP joint
radiographic finding : medial deviation of first Metatarsal bone , and lateral deviation of Big toe
complete a follow up period of 1 year , filling questionaires and undergone radiographic examination every visit
radiographic finding : Hallux valgus angle >20 , Intermetatarsal angle > 10 degrees
failed conservative treatment for atleast 8 months , with persistent pain along medial eminence and having difficulty walking, bearing weight