- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07621328
Outcomes of Eight-Plate Epiphysiodesis for Residual Clubfoot Deformities (clubfoot)
Purpose:
The purpose of this prospective clinical study is to evaluate the radiographic outcomes, effectiveness, and safety of lateral calcaneocuboid guided growth using an extra-periosteal tension-band plate (eight-plate) to correct residual forefoot adduction (often referred to as a "bean-shaped foot") in growing children with relapsed idiopathic clubfoot.
Condition and Intervention:
Residual forefoot adduction remains a challenging deformity following primary infant clubfoot treatment. While traditional management often relies on invasive double-column midfoot osteotomies-which carry risks of permanent joint stiffness, nonunion, and cartilage damage-this study investigates a minimally invasive alternative. Eligible pediatric patients (ages 4 to 10 years) with symptomatic, flexible or partially flexible residual forefoot adduction undergo temporary lateral calcaneocuboid epiphysiodesis using an extra-periosteal eight-plate and two cannulated screws.
Methodology & Expected Outcomes:
Patients are clinically categorized into simple relapses (isolated, flexible forefoot adduction) and complex relapses (rigid deformities associated with hindfoot varus or equinus) to evaluate treatment efficacy across different deformity profiles. Radiographic parameters, including the anteroposterior talo-first metatarsal angle (T1MA), calcaneo-fifth metatarsal angle (C5MA), and the medial-to-lateral (M/L) column ratio, are tracked postoperatively every 3 months. The primary goal is to determine if restricting lateral midfoot column growth allows the shorter medial column to catch up proportionally, thereby restoring normal foot alignment and preserving joint range of motion without the morbidity of structural bone cuts. Patients are monitored for complications, such as hardware loosening, and are tracked long-term until definitive skeletal maturity.
Обзор исследования
Статус
Подробное описание
Purpose:
The purpose of this prospective clinical study is to evaluate the radiographic outcomes, effectiveness, and safety of lateral calcaneocuboid guided growth using an extra-periosteal tension-band plate (eight-plate) to correct residual forefoot adduction (often referred to as a "bean-shaped foot") in growing children with relapsed idiopathic clubfoot.
Condition and Intervention:
Residual forefoot adduction remains a challenging deformity following primary infant clubfoot treatment. While traditional management often relies on invasive double-column midfoot osteotomies-which carry risks of permanent joint stiffness, nonunion, and cartilage damage-this study investigates a minimally invasive alternative. Eligible pediatric patients (ages 4 to 10 years) with symptomatic, flexible or partially flexible residual forefoot adduction undergo temporary lateral calcaneocuboid epiphysiodesis using an extra-periosteal eight-plate and two cannulated screws.
Methodology & Expected Outcomes:
Patients are clinically categorized into simple relapses (isolated, flexible forefoot adduction) and complex relapses (rigid deformities associated with hindfoot varus or equinus) to evaluate treatment efficacy across different deformity profiles. Radiographic parameters, including the anteroposterior talo-first metatarsal angle (T1MA), calcaneo-fifth metatarsal angle (C5MA), and the medial-to-lateral (M/L) column ratio, are tracked postoperatively every 3 months. The primary goal is to determine if restricting lateral midfoot column growth allows the shorter medial column to catch up proportionally, thereby restoring normal foot alignment and preserving joint range of motion without the morbidity of structural bone cuts. Patients are monitored for complications, such as hardware loosening, and are tracked long-term until definitive skeletal maturity.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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-
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Giza, Египет
- Cairo University
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
the children's age should be from 4 to 10 years old. children with clubfoot who still had symptomatic residual forefoot adduction
Exclusion Criteria:
- patients who had dynamic forefoot adduction
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Simple Relapse Subgroup
Pediatric patients presenting with isolated, flexible residual forefoot adduction following primary infant clubfoot treatment.
These patients do not exhibit rigid multi-planar deformities or associated significant hindfoot varus.
|
emporary lateral calcaneocuboid joint epiphysiodesis using a tension-band plate (eight-plate).
Under fluoroscopic guidance, a 2 cm lateral longitudinal incision is made over the joint line, and the eight-plate is transfixed across the calcaneocuboid physis using two 3.5 mm cannulated screws to gradually restrict lateral column overgrowth and allow medial column alignment
lateral calcaneocuboid joint epiphysiodesis using a tension-band plate (eight-plate).
Under fluoroscopic guidance, a 2 cm lateral longitudinal incision is made over the joint line, and the eight-plate is transfixed across the calcaneocuboid physis using two 3.5 mm cannulated screws to gradually restrict lateral column overgrowth and allow medial column alignment.
|
|
Complex Relapse Subgroup
Pediatric patients presenting with rigid midfoot residual adduction components accompanied by fixed hindfoot varus or fixed equinus deformities following primary infant clubfoot treatment
|
emporary lateral calcaneocuboid joint epiphysiodesis using a tension-band plate (eight-plate).
Under fluoroscopic guidance, a 2 cm lateral longitudinal incision is made over the joint line, and the eight-plate is transfixed across the calcaneocuboid physis using two 3.5 mm cannulated screws to gradually restrict lateral column overgrowth and allow medial column alignment
lateral calcaneocuboid joint epiphysiodesis using a tension-band plate (eight-plate).
Under fluoroscopic guidance, a 2 cm lateral longitudinal incision is made over the joint line, and the eight-plate is transfixed across the calcaneocuboid physis using two 3.5 mm cannulated screws to gradually restrict lateral column overgrowth and allow medial column alignment.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
talo-first metatarsal angle (TM1A)
Временное ограничение: up to 24 months postoperatively (Final follow-up)
|
measuring talo-first metatarsal angle (TM1A) pre and post
|
up to 24 months postoperatively (Final follow-up)
|
|
the calcaneo-fifth metatarsal angle (CM5A)
Временное ограничение: 24 month
|
measuring angle the calcaneo-fifth metatarsal angle (CM5A)
|
24 month
|
|
the length of the medial and lateral column ratio
Временное ограничение: 24 month
|
24 month
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Талипы
- Заболевания опорно-двигательного аппарата
- Скелетно-мышечные аномалии
- Врожденные аномалии
- Деформации нижних конечностей, врожденные
- Деформации конечностей, врожденные
- Деформации стопы
- Деформации стопы, приобретенные
- Деформации стопы, врожденные
- Врожденные, наследственные и неонатальные заболевания и аномалии
- Косолапость
Другие идентификационные номера исследования
- MD-477-2023
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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