SPLATT to Peroneus Brevis vs TATT to Lateral Cuneiform (Recurrent CTEV)

Split Tibialis Anterior Tendon Transfer to Peroneus Brevis vs Total Tibialis Anterior Tendon Transfer to Lateral Cuneiform in Recurrent Congenital Talipes Equinovarus: A Randomized Controlled Trial

Congenital talipes equinovarus, is a common congenital foot deformity involving hindfoot equinus and varus, along with mid-/forefoot adduction and cavus. Currently, the Ponseti method is the preferred initial treatment for idiopathic clubfoot1

. Despite the initial phase's remarkable efficacy in correcting clubfeet, there remains a notable recurrence rate after Ponseti treatment2

• Numerous studies demonstrate a very high success rate during early follow-ups, ranging from 92% to 100%3
• Nonetheless, recurrence remains a challenge for orthopedic surgeons. A common trigger for recurrence is the dynamic supination of the foot, which results from excessive activation of the tibialis anterior muscle during ankle dorsiflexion4

Multiple studies indicate that tibialis anterior tendon transfer (TATT) is an effective tool for management of clubfoot recurrence, particularly dynamic supination5

• The widely used technique involves transferring the entire tendon through a drill hole in the lateral cuneiform and anchoring it on the plantar aspect of the foot using a sewing button and felt pad6
• While effective, this procedure raises the risk of pressure sores due to button placement on the sole7

Split anterior tibialis tendon transfer (SPLATT) to peroneus brevis is a well-described treatment strategy of varus foot deformities in patients with neuromuscular disorders8

• The technique has been reported to achieve successful deformity correction while avoiding skin problems associated with external button placement on the sole of the foot in tendon-to-bone transfers8

The present study aims to assess the outcome of utilizing SPLATT to peroneus brevis procedure in the treatment of recurrent CTEV in comparison to the original total TATT to the lateral cuneiform

Study Overview

• Status: Enrolling by invitation
• Conditions: Recurrent Congenital Talipes Equinovarus
• Intervention / Treatment: Procedure: SPLATT

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Recurrent CTEV
• Age between 4 years and 12 years
• Unilateral/bilateral
• Ankle dorsiflexion of at least 10° prior to tendon transfer

Exclusion Criteria:

• Non idiopathic CTEV
• Rigid deformity not suitable for acute correction
• Poor skin condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPLATT; Children with congenital talipes who have been treated with split tibialis anterior tendon transfer to peroneus brevis	Procedure: SPLATT; split tibialis anterior tendon transfer to peroneus brevis total tibialis anterior tendon transfer to lateral cuneiform; Other Names: TATT
Experimental: TATT; Children with congenital talipes who have been treated with total ribialis anterior tendon transfer to lateral cuneiform	Procedure: SPLATT; split tibialis anterior tendon transfer to peroneus brevis total tibialis anterior tendon transfer to lateral cuneiform; Other Names: TATT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correction of recurrent congenital talipes	correction is measured by arc of eversion	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 3, 2024
• First Submitted That Met QC Criteria: March 3, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Clubfoot; Talipes; Equinus Deformity
• Other Study ID Numbers: SPLATTvsTATT in recurrent CTEV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No