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Status unknownNCT04212663Updated Dec 27, 2019

A Study on the Treatment of Recurrent Clubfoot With the Tendon Release of Musculi Tibialis Posterior

An interventional study of The tendon release of musculi tibialis posterior and Anterior tibial tendon transfer(TATT) in Recurrent Clubfoot, sponsored by Guangzhou Women and Children's Medical Center. Status unknown. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2019-12-27.

Sponsored by Guangzhou Women and Children's Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Not yet recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
4 Years to 6 Years
Sex
All
01

Study summary

The musculi tibialis posterior can adduct the foot, so releasing the tedon of the muscle can help to correct the deformity of the forefoot adduction.

02

Conditions studied

  • Recurrent Clubfoot

Browse trials for

Keywords

  • Musculi tibialis posterior
  • Tendon release
  • Anterior tibial tendon transfer
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 80 is above the median of 38 across 40 interventional studies indexed under Clubfoot.

Browse Clubfoot studies →

Lead sponsor

Guangzhou Women and Children's Medical Center is the lead sponsor of 58 studies on the registry; 30 are open to participants now.

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

04

Who can participate

Ages eligible
4 Years to 6 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

  • Clinical diagnosis of recurrent idiopathic clubfoot
  • The initial treatment was treated with the ponseti method
  • Dynamic supination
  • The max-dorsiflexion of angle \<5°
  • The fore foot is adduct
  • The sole is cavus

Exclusion criteria

Exclusion Criteria:

  • Symptomatic recurrent clubfoot
  • Tarsal fusion
  • Rigid recurrent clubfoot
05

Study design

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

Study arms

  • Placebo comparator
    control

    receive the procure of Anterior tibial tendon transfer(TATT) + Achilles tendon lengthing + fascial release

    Procedure: Anterior tibial tendon transfer(TATT) · Procedure: Achilles tendon lengthing · Procedure: Fascial release

  • Experimental
    experiment

    receive the procure of Anterior tibial tendon transfer(TATT) + Achilles tendon lengthing + fascial release+ The tendon release of musculi tibialis posterior

    Procedure: The tendon release of musculi tibialis posterior · Procedure: Anterior tibial tendon transfer(TATT) · Procedure: Achilles tendon lengthing · Procedure: Fascial release

Interventions

  • ProcedureThe tendon release of musculi tibialis posterior

    To release the tendon of musculi tibialis posterior.

  • ProcedureAnterior tibial tendon transfer(TATT)

    To transfer the the tendon of anterior tibial from the navicular to the third cuneiform.

  • ProcedureAchilles tendon lengthing

    To lengthen the achilles tendon by using two incisions.

  • ProcedureFascial release

    To cut off the metatarsal fascia in the middle part.

06

What researchers measure

Primary outcomes

  1. The adduction of foot.

    Measure the angle of foot adduction

    Time frame: Six months after the operation

  2. The adduction of foot.

    Measure the angle of foot adduction

    Time frame: 1 year after operation

Secondary outcomes

  1. The dorsiflextion of ankle.

    Measure the angle of ankle dorsiflextion

    Time frame: Six months after the operation

  2. The dorsiflextion of ankle.

    Measure the angle of ankle dorsiflextion

    Time frame: 1 year after operation

07

Study locations

No study locations are listed for this record.

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

Start is estimated for Feb 2020; primary completion for Feb 2020, 0 months later.

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 0 months is below that.

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

Registered
Sep 21, 2019
First posted
Dec 27, 2019
StartEst.
Feb 1, 2020
Primary completionEst.
Feb 1, 2020
CompletionEst.
Sep 25, 2021
Last update
Dec 27, 2019
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 Dec 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04212663
Lead sponsor
Guangzhou Women and Children's Medical Center
Responsible party
Hongwen Xu (The director of pediatric orthopedic depatment, Guangzhou Women and Children's Medical Center) — Principal investigator
First posted
Dec 27, 2019
Start date
Feb 1, 2020 (estimated)
Primary completion
Feb 1, 2020 (estimated)
Completion
Sep 25, 2021 (estimated)
Last update
Dec 27, 2019

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Guangzhou Women and Children's Medical Center

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