Midfoot Osteotomy Versus 8-Plate Epiphysiodesis for Residual Metatarsal Adductus

NCT07466043 | Not Yet Recruiting DMC

• 1 other identifier: orthopedic
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Epiphysiodesis

Conditions

Club Foot

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after surgery

Study Arms (2)

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.

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.

Procedure: 8-Plate Epiphysiodesis

Interventions

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

Midfoot Osteotomy

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.

8-Plate Epiphysiodesis

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 36254364 RESULT

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Mahmoud Ali Hassan, specialist

CONTACT

01062637403; mahmoudnoble2021@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist of orthopedic surgery

Model Details: * 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

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 12, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): February 18, 2027
• Study Completion (Estimated): February 18, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share