Outcomes of Eight-Plate Epiphysiodesis for Residual Clubfoot Deformities

NCT07621328 | Completed DMC

• 1 other identifier: MD-477-2023
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clubfoot Deformity; Forefoot Adductus

Keywords

Clubfoot; Residual forefoot adduction; Guided growth; Eight-plate; Medial-lateral column ratio; Pediatric foot deformity.

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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)

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)

Interventions

Lateral Calcaneocuboid Guided Growth (Eight-Plating) PROCEDURE

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

Complex Relapse Subgroup; Simple Relapse Subgroup

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• the children's age should be from 4 to 10 years old. children with clubfoot who still had symptomatic residual forefoot adduction

You may not qualify if:

• patients who had dynamic forefoot adduction

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Giza, Egypt

Location

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NINMS

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: January 18, 2024
• Primary Completion: January 18, 2026
• Study Completion: January 18, 2026
• Last Updated: June 2, 2026

Record last verified: 2023-10

Locations

EG (1)