Recurrent Congenital Talipes EquinovarusRecurrent CTEVNCT06300645
SPLATT to Peroneus Brevis vs TATT to Lateral Cuneiform
A study testing SPLATT in people with Recurrent Congenital Talipes Equinovarus, run by Assiut University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Recurrent Congenital Talipes Equinovarus
- What is being tested?
- SPLATT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jan 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Recurrent CTEV
- Age between 4 years and 12 years
- Unilateral/bilateral
- Ankle dorsiflexion of at least 10° prior to tendon transfer
Who cannot join
- Non idiopathic CTEV
- Rigid deformity not suitable for acute correction
- Poor skin condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
- 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
- Conditions
- Recurrent Congenital Talipes Equinovarus
- Being tested
- SPLATT
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPLATTProcedure or surgery
Also called TATT
split tibialis anterior tendon transfer to peroneus brevis total tibialis anterior tendon transfer to lateral cuneiform
| Study group | Role | What they receive |
|---|---|---|
| SPLATT | Experimental | Children with congenital talipes who have been treated with split tibialis anterior tendon transfer to peroneus brevis Receives: Procedure: SPLATT |
| TATT | Experimental | Children with congenital talipes who have been treated with total ribialis anterior tendon transfer to lateral cuneiform Receives: Procedure: SPLATT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correction of recurrent congenital talipes
correction is measured by arc of eversion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start17 Jan 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Congenital Talipes EquinovarusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Yahya Abdelazeem Hassanein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300645
- Sponsor's protocol ID
- SPLATTvsTATT in recurrent CTEV
- Acronym
- Recurrent CTEV
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06300645
- Acronym / sponsor ID
- Recurrent CTEV / SPLATTvsTATT in recurrent CTEV
- Conditions
- Recurrent Congenital Talipes Equinovarus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPLATT | Experimental | Procedure: SPLATTChildren with congenital talipes who have been treated with split tibialis anterior tendon transfer to peroneus brevis |
| TATT | Experimental | Procedure: SPLATTChildren with congenital talipes who have been treated with total ribialis anterior tendon transfer to lateral cuneiform |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Recurrent CTEV
- Age between 4 years and 12 years
- Unilateral/bilateral
- Ankle dorsiflexion of at least 10° prior to tendon transfer
Key exclusion criteria (3 listed)
- Non idiopathic CTEV
- Rigid deformity not suitable for acute correction
- Poor skin condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPLATTAlso: TATTsplit tibialis anterior tendon transfer to peroneus brevis total tibialis anterior tendon transfer to lateral cuneiform | Procedure or surgery | SPLATT, TATT |
Primary outcome
Correction of recurrent congenital talipes
Time frame: 1 year
correction is measured by arc of eversion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Related trials for Recurrent Congenital Talipes Equinovarus
Active, not recruitingObservational study
Predictive Value of the PBS-score in Children With Clubfoot
Clubfoot
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPLATT in people with Recurrent Congenital Talipes Equinovarus, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correction of recurrent congenital talipes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.