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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
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Giza, Egitto
- Cairo university
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
talo-first metatarsal angle (TM1A)
Lasso di tempo: 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)
Lasso di tempo: 24 month
|
measuring angle the calcaneo-fifth metatarsal angle (CM5A)
|
24 month
|
|
the length of the medial and lateral column ratio
Lasso di tempo: 24 month
|
24 month
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Talipe
- Malattie muscoloscheletriche
- Anomalie muscoloscheletriche
- Anomalie congenite
- Deformità degli arti inferiori, congenite
- Deformità degli arti, congenite
- Deformità del piede
- Deformità del piede, acquisite
- Deformità del piede, congenite
- Malattie e anomalie congenite, ereditarie e neonatali
- Piede equino
Altri numeri di identificazione dello studio
- MD-477-2023
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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