Clubfoot DeformityclubfootNCT07621328
Outcomes of Eight-Plate Epiphysiodesis for Residual Clubfoot Deformities
An observational study of Clubfoot Deformity and Forefoot Adductus, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Clubfoot Deformity, Forefoot Adductus
- What is being tested?
- Lateral Calcaneocuboid Guided Growth (Eight-Plating)
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2024to 18 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- the children's age should be from 4 to 10 years old. children with clubfoot who still had symptomatic residual forefoot adduction
Who cannot join
- patients who had dynamic forefoot adduction
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Clubfoot Deformity, Forefoot Adductus
- Being tested
- Lateral Calcaneocuboid Guided Growth (Eight-Plating)
- Keywords
- Clubfoot; Residual forefoot adduction; Guided growth; Eight-plate; Medial-lateral column ratio; Pediatric foot deformity.
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Calcaneocuboid Guided Growth (Eight-Plating)Procedure or surgery
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 Guided Growth (Eight-Plating)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Lateral Calcaneocuboid Guided Growth (Eight-Plating) |
What is being measured
The primary outcome is the main question the study is designed to answer.
talo-first metatarsal angle (TM1A)
measuring talo-first metatarsal angle (TM1A) pre and post
Measured: up to 24 months postoperatively (Final follow-up)
the calcaneo-fifth metatarsal angle (CM5A)
measuring angle the calcaneo-fifth metatarsal angle (CM5A)
Measured: 24 month
the length of the medial and lateral column ratio
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start18 Jan 2024
- Primary completion18 Jan 2026
- Study completion18 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clubfoot DeformityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sobhy Ali Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621328
- Sponsor's protocol ID
- MD-477-2023
- Acronym
- clubfoot
- Status last verified
- Oct 2023
- First submitted
- 27 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Eight-Plate Epiphysiodesis for Residual Clubfoot Deformities
- ClinicalTrials.gov ID
- NCT07621328
- Acronym / sponsor ID
- clubfoot / MD-477-2023
- Conditions
- Clubfoot Deformity, Forefoot Adductus
- Keywords
- Clubfoot; Residual forefoot adduction; Guided growth; Eight-plate; Medial-lateral column ratio; Pediatric foot deformity.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 18 Jan 2026 (actual)
- Study completion
- 18 Jan 2026 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple Relapse Subgroup | – | Procedure: Lateral Calcaneocuboid Guided Growth (Eight-Plating)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. |
| Complex Relapse Subgroup | – | Procedure: Lateral Calcaneocuboid Guided Growth (Eight-Plating)Pediatric patients presenting with rigid midfoot residual adduction components accompanied by fixed hindfoot varus or fixed equinus deformities following primary infant clubfoot treatment |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- the children's age should be from 4 to 10 years old. children with clubfoot who still had symptomatic residual forefoot adduction
Key exclusion criteria (1 listed)
- patients who had dynamic forefoot adduction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Complex Relapse Subgroup, Simple Relapse Subgroup |
| 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. | Procedure or surgery | Complex Relapse Subgroup, Simple Relapse Subgroup |
Primary outcome
talo-first metatarsal angle (TM1A)
Time frame: up to 24 months postoperatively (Final follow-up)
measuring talo-first metatarsal angle (TM1A) pre and post
the calcaneo-fifth metatarsal angle (CM5A)
Time frame: 24 month
measuring angle the calcaneo-fifth metatarsal angle (CM5A)
the length of the medial and lateral column ratio
Time frame: 24 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot Deformity and Forefoot Adductus, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
talo-first metatarsal angle (TM1A) (time frame: up to 24 months postoperatively (Final follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.