SPLATT to Peroneus Brevis vs TATT to Lateral Cuneiform | NCT06300645

Studies
SPLATT to Peroneus Brevis vs TATT to Lateral Cuneiform

NCT06300645

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 12, 2024Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Recurrent Congenital Talipes Equinovarus

Interventions

SPLATT

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2024Actual

Primary Completion Date

Mar 1, 2025Estimated

Completion Date

Mar 1, 2026Estimated

First Submitted Date

Mar 3, 2024

First Submission Date that Met QC Criteria

Mar 3, 2024

First Posted Date

Mar 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2024

Last Update Posted Date

Mar 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Yahya Abdelazeem Hassanein, Resident, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SPLATT	Experimental	Children with congenital talipes who have been treated with split tibialis anterior tendon transfer to peroneus brevis	Procedure: SPLATT
TATT	Experimental	Children with congenital talipes who have been treated with total ribialis anterior tendon transfer to lateral cuneiform	Procedure: SPLATT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPLATT	Procedure	split tibialis anterior tendon transfer to peroneus brevis total tibialis anterior tendon transfer to lateral cuneiform	SPLATT TATT

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university hospital		Asyut		71515	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D003025	Clubfoot

Ancestor Terms

ID	Term
D000070558	Talipes
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

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