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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Giza, Egypten
- Cairo University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
talo-first metatarsal angle (TM1A)
Tidsram: 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)
Tidsram: 24 month
|
measuring angle the calcaneo-fifth metatarsal angle (CM5A)
|
24 month
|
|
the length of the medial and lateral column ratio
Tidsram: 24 month
|
24 month
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MD-477-2023
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .