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Enrolling by invitationNCT06300645Recurrent CTEVUpdated Mar 12, 2024

SPLATT to Peroneus Brevis vs TATT to Lateral Cuneiform

An interventional study of SPLATT in Recurrent Congenital Talipes Equinovarus, sponsored by Assiut University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-03-12.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as enrolling by invitation.

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Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
4 Years to 12 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Recurrent Congenital Talipes Equinovarus

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03

In context

Clubfoot

69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.

This study's planned enrollment of 25 is below the median of 38 across 40 interventional studies indexed under Clubfoot.

Browse Clubfoot studies →

Lead sponsor

Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Assiut University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Non idiopathic CTEV
  • Rigid deformity not suitable for acute correction
  • Poor skin condition
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    SPLATT

    Children with congenital talipes who have been treated with split tibialis anterior tendon transfer to peroneus brevis

    Procedure: SPLATT

  • Experimental
    TATT

    Children with congenital talipes who have been treated with total ribialis anterior tendon transfer to lateral cuneiform

    Procedure: SPLATT

Interventions

  • ProcedureSPLATT

    split tibialis anterior tendon transfer to peroneus brevis total tibialis anterior tendon transfer to lateral cuneiform

    Also known as: TATT

06

What researchers measure

Primary outcomes

  1. Correction of recurrent congenital talipes

    correction is measured by arc of eversion

    Time frame: 1 year

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Mar 2025, 13 months after the start.

Of 20 interventional studies with no phase under Clubfoot, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's planned 13 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2024
First posted
Mar 8, 2024
StartActual
Jan 17, 2024
Primary completionEst.
Mar 1, 2025
CompletionEst.
Mar 1, 2026
Last update
Mar 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06300645
Lead sponsor
Assiut University
Responsible party
Mahmoud Yahya Abdelazeem Hassanein (Resident, Assiut University) — Principal investigator
First posted
Mar 8, 2024
Start date
Jan 17, 2024
Primary completion
Mar 1, 2025 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Mar 12, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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