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Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus

Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus in Relapsed Congenital Talipes Equinovarus

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07466043
Enrollment
40
Registered
2026-03-12
Start date
2026-03-30
Completion date
2028-02-18
Last updated
2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Club Foot

Brief summary

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.

Interventions

PROCEDUREMidfoot Osteotomy

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

PROCEDURE8-Plate Epiphysiodesis

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
To compare the results of the two technical procedures of surgical treatment by Radiological correction6 months after surgeryradiological correction assessed using the Demiglio score to evaluate the outcome of the two surgical techniques.

Contacts

CONTACTMahmoud Ali Hassan, specialist
mahmoudnoble2021@gmail.com01062637403

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026