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Outcomes of Eight-Plate Epiphysiodesis for Residual Clubfoot Deformities

NCT07621328 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2026-06-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2026-01-18
Completion
2026-01-18

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07621328 on ClinicalTrials.gov