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.

Study Overview

• Status: Completed
• Conditions: Forefoot Adductus; Clubfoot Deformity
• Intervention / Treatment: Procedure: Lateral Calcaneocuboid Guided Growth (Eight-Plating); Procedure: Lateral Calcaneocuboid Guided Growth (Eight-Plating)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

diatric patients presenting with symptomatic, flexible or partially flexible residual forefoot adduction (the clinical "bean-shaped foot") who had failed prior conservative management following primary treatment for idiopathic congenital clubfoot. The study cohort was recruited from a tertiary pediatric orthopedic center and followed prospectively to evaluate the outcomes of lateral column growth modulation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Lateral Calcaneocuboid Guided Growth (Eight-Plating); 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; Procedure: Lateral Calcaneocuboid Guided Growth (Eight-Plating); 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	Procedure: Lateral Calcaneocuboid Guided Growth (Eight-Plating); 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; Procedure: Lateral Calcaneocuboid Guided Growth (Eight-Plating); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
talo-first metatarsal angle (TM1A)	measuring talo-first metatarsal angle (TM1A) pre and post	up to 24 months postoperatively (Final follow-up)
the calcaneo-fifth metatarsal angle (CM5A)	measuring angle the calcaneo-fifth metatarsal angle (CM5A)	24 month
the length of the medial and lateral column ratio		24 month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Actual): January 18, 2026
• Study Completion (Actual): January 18, 2026

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Clubfoot; Residual forefoot adduction; Guided growth; Eight-plate; Medial-lateral column ratio; Pediatric foot deformity.
• Additional Relevant MeSH Terms: Talipes; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Clubfoot
• Other Study ID Numbers: MD-477-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No