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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
Giza, Egypt
- Cairo university
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
talo-first metatarsal angle (TM1A)
Časové okno: 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)
Časové okno: 24 month
|
measuring angle the calcaneo-fifth metatarsal angle (CM5A)
|
24 month
|
|
the length of the medial and lateral column ratio
Časové okno: 24 month
|
24 month
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MD-477-2023
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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