Club FootNCT07466043
Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus
A study testing Midfoot Osteotomy and 8-Plate Epiphysiodesis in people with Club Foot, run by Assiut University.
Trial summary
Epiphysiodesis Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Club Foot
- What is being tested?
- Midfoot Osteotomy and 8-Plate Epiphysiodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 18 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients are eligible for participation in the study if
- Age between 5 to 10 years old
- Relapsed idiopathic clubfoot (CTEV)
- Presence of residual metatarsal adductus
Who cannot join
- Patients are excluded for participation in the study if
- Teratologic clubfoot (e.g., myelomeningocele).
- Children under 4 years of mild severity that could be corrected with conservative treatment, or above 10 years old.
- flexible (correctable) deformity of the foot.
- Cases recurrent after midtarsal osteotomy
- Neuromuscular CTEV, or arthrogryposis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus in Relapsed Congenital Talipes Equinovarus
Epiphysiodesis
Read the detailed description
Congenital Talipes Equinovarus (CTEV) is a significant musculoskeletal deformity affecting children globally. It is characterized by hindfoot varus, midfoot cavus, forefoot adduction, and ankle equines (1). The Ponseti method has proven to be highly effective and is now the gold standard for treatment. However, long-term follow-up studies indicate a variable relapse rate. Timely diagnosis of relapse is crucial, underscoring the importance of regular follow-up visits (2).
Nowadays the method has replaced the surgery and served as the gold standard for the treatment of congenital clubfoot in pediatric orthopedics(3) . However, it is still challenging to treat severe cases such as neglected or relapsed clubfoot in older children(4). Among the deformities, residual forefoot adduction with supination after treatment is a common issue which is also referred to as the "bean-shaped foot"( 5) . According to Jasiewicz et.al study, the combination of a cuboid closing with a cuneiform opening wedge osteotomy or with a trans-midfoot osteotomy is currently the most popular procedure to correct the residual forefoot adduction(6).
However, complications such as neurovascular lesion, non-union or permanent foot stiffness might occur as a result of the operation. In addition, the tarsal growth plate and cartilaginous area could be compromised due to the difficulty in manipulating the osteotomy and fixation process(7). 8-plate is one of the major methods that gained popularity quickly due to temporary growth impediment of the physis without damaging it irreversibly, and is suitable for a variety of indications including different plane deformities around the knee and limb length discrepancies(8). However, there are a few reports regarding 8-plates in individuals with clubfoot deformities. Recently, guided growth techniques using temporary epiphysiodesis (8 -plate) have been introduced as a minimally invasive alternative that allows gradual correction by modulating growth.However, high-quality comparative clinical evidence between these two techniques is lacking.
The current research is the first one to compare the clinical, radiological, and patient satisfaction outcome of midfoot osteotomy versus eight -Plate epiphysiodesis for residual metatarsal adductus in relapsed clubfoot.The purpose of this prospective study is to show the best technique to achieve patient satisfaction.
- Conditions
- Club Foot
- Being tested
- Midfoot Osteotomy, 8-Plate Epiphysiodesis
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midfoot OsteotomyProcedure or surgery
Group 1 Immobilization in along leg (above knee cast) for 6 weeks Non-weight bearing during casting period Cast removal followed by gradual return to weight bearing
8-Plate EpiphysiodesisProcedure or surgery
NO immobilization, only protective splinting for 2 weeks as postoperative rest, after splint removal return to normal activity. Plate will be removed after full clinical and radiological correction. Further procedures e.g. tibalis anterior tendon transfer can be done as needed.
| Study group | Role | What they receive |
|---|---|---|
| Midfoot Osteotomy | Active comparator | A closing wedge osteotomy of the cuboid will be performed using an oscillating saw, with the wedge size determined according to the severity of forefoot adduction. Receives: Procedure: Midfoot Osteotomy |
| 8-Plate Epiphysiodesis | Active comparator | A guidewire will be inserted to confirm proper positioning. A tension-band eight-plate was will then be placed bridging the lateral side of the calcaneocuboid region, with two cannulated 3.5 mm screws inserted-one into the cuboid and one into the calcaneus-ensuring central placement within the cuboid to modulate lateral column growth. Receives: Procedure: 8-Plate Epiphysiodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the results of the two technical procedures of surgical treatment by Radiological correction
radiological correction assessed using the Demiglio score to evaluate the outcome of the two surgical techniques.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion18 Feb 2027 (estimated)
- Study completion18 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Club FootStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- * Full history taking * Clinical examination with gait assessment (video assisted) * Radiological evaluation will be performed using standardized anteroposterior and lateral foot radiographs. Measurements included the talo-first metatarsal angle, calcaneo-fifth metatarsal angle, talocalcaneal angle, and Meary's angle. Radiographs will be obtained preoperatively and during follow-up. The pre- and latest follow up after full correction radiographic parameters of each enrolled patient will be compared separately. Operative procedure: In this study, patients will be divided into two groups randomly. Group1: Midfoot Osteotomy for Residual Metatarsal Adducts Group 2: Guided Growth Using 8-Plate Epiphysiodesis
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ali Hassan Abdelhamid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466043
- Sponsor's protocol ID
- orthopedic
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao H, Ruan H, Cao Y, Yuan H, Kang Q. Outcomes of Eight-Plate Epiphysiodesis for Residual Clubfoot Deformities. Orthop Surg. 2022 Dec;14(12):3417-3422. doi: 10.1111/os.13548. Epub 2022 Oct 17.
PubMed 36254364
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus in Relapsed Congenital Talipes Equinovarus
- ClinicalTrials.gov ID
- NCT07466043
- Acronym / sponsor ID
- orthopedic
- Conditions
- Club Foot
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 18 Feb 2027 (estimated)
- Study completion
- 18 Feb 2028 (estimated)
- First posted
- 12 Mar 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.
Epiphysiodesis
Detailed description
Congenital Talipes Equinovarus (CTEV) is a significant musculoskeletal deformity affecting children globally. It is characterized by hindfoot varus, midfoot cavus, forefoot adduction, and ankle equines (1). The Ponseti method has proven to be highly effective and is now the gold standard for treatment. However, long-term follow-up studies indicate a variable relapse rate. Timely diagnosis of relapse is crucial, underscoring the importance of regular follow-up visits (2).
Nowadays the method has replaced the surgery and served as the gold standard for the treatment of congenital clubfoot in pediatric orthopedics(3) . However, it is still challenging to treat severe cases such as neglected or relapsed clubfoot in older children(4). Among the deformities, residual forefoot adduction with supination after treatment is a common issue which is also referred to as the "bean-shaped foot"( 5) . According to Jasiewicz et.al study, the combination of a cuboid closing with a cuneiform opening wedge osteotomy or with a trans-midfoot osteotomy is currently the most popular procedure to correct the residual forefoot adduction(6).
However, complications such as neurovascular lesion, non-union or permanent foot stiffness might occur as a result of the operation. In addition, the tarsal growth plate and cartilaginous area could be compromised due to the difficulty in manipulating the osteotomy and fixation process(7). 8-plate is one of the major methods that gained popularity quickly due to temporary growth impediment of the physis without damaging it irreversibly, and is suitable for a variety of indications including different plane deformities around the knee and limb length discrepancies(8). However, there are a few reports regarding 8-plates in individuals with clubfoot deformities. Recently, guided growth techniques using temporary epiphysiodesis (8 -plate) have been introduced as a minimally invasive alternative that allows gradual correction by modulating growth.However, high-quality comparative clinical evidence between these two techniques is lacking.
The current research is the first one to compare the clinical, radiological, and patient satisfaction outcome of midfoot osteotomy versus eight -Plate epiphysiodesis for residual metatarsal adductus in relapsed clubfoot.The purpose of this prospective study is to show the best technique to achieve patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Full history taking * Clinical examination with gait assessment (video assisted) * Radiological evaluation will be performed using standardized anteroposterior and lateral foot radiographs. Measurements included the talo-first metatarsal angle, calcaneo-fifth metatarsal angle, talocalcaneal angle, and Meary's angle. Radiographs will be obtained preoperatively and during follow-up. The pre- and latest follow up after full correction radiographic parameters of each enrolled patient will be compared separately. Operative procedure: In this study, patients will be divided into two groups randomly. Group1: Midfoot Osteotomy for Residual Metatarsal Adducts Group 2: Guided Growth Using 8-Plate Epiphysiodesis
| Arm | Type | Receives |
|---|---|---|
| Midfoot Osteotomy | Active comparator | Procedure: Midfoot OsteotomyA closing wedge osteotomy of the cuboid will be performed using an oscillating saw, with the wedge size determined according to the severity of forefoot adduction. |
| 8-Plate Epiphysiodesis | Active comparator | Procedure: 8-Plate EpiphysiodesisA guidewire will be inserted to confirm proper positioning. A tension-band eight-plate was will then be placed bridging the lateral side of the calcaneocuboid region, with two cannulated 3.5 mm screws inserted-one into the cuboid and one into the calcaneus-ensuring central placement within the cuboid to modulate lateral column growth. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients are eligible for participation in the study if
Key exclusion criteria (6 listed)
- Patients are excluded for participation in the study if
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 |
|---|---|---|
| Midfoot OsteotomyGroup 1 Immobilization in along leg (above knee cast) for 6 weeks Non-weight bearing during casting period Cast removal followed by gradual return to weight bearing | Procedure or surgery | Midfoot Osteotomy |
| 8-Plate EpiphysiodesisNO immobilization, only protective splinting for 2 weeks as postoperative rest, after splint removal return to normal activity. Plate will be removed after full clinical and radiological correction. Further procedures e.g. tibalis anterior tendon transfer can be done as needed. | Procedure or surgery | 8-Plate Epiphysiodesis |
Primary outcome
To compare the results of the two technical procedures of surgical treatment by Radiological correction
Time frame: 6 months after surgery
radiological correction assessed using the Demiglio score to evaluate the outcome of the two surgical techniques.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Results publication: PubMed 36254364Zhao H, Ruan H, Cao Y, Yuan H, Kang Q. Outcomes of Eight-Plate Epiphysiodesis for Residual Clubfoot Deformities. Orthop Surg. 2022 Dec;14(12):3417-3422. doi: 10.1111/os.13548. Epub 2022 Oct 17.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Midfoot Osteotomy and 8-Plate Epiphysiodesis in people with Club Foot, run by Assiut University.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Ali Hassan, specialist (01062637403, mahmoudnoble2021@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the results of the two technical procedures of surgical treatment by Radiological correction (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07466043, which also lists 1 linked publication.
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 3 Apr 2026.