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NCT Number: NCT07466043

Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus

Epiphysiodesis

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midfoot Osteotomy

Procedure

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 Epiphysiodesis

Procedure

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Ali Hassan, specialist

CONTACT

[email protected]

01062637403

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 12, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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