search
Back to results

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

Primary Purpose

Recurrent Clubfoot

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The tendon release of musculi tibialis posterior
Anterior tibial tendon transfer(TATT)
Achilles tendon lengthing
Fascial release
Sponsored by
Guangzhou Women and Children's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Clubfoot focused on measuring Musculi tibialis posterior, Tendon release, Anterior tibial tendon transfer

Eligibility Criteria

4 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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:

  • Symptomatic recurrent clubfoot
  • Tarsal fusion
  • Rigid recurrent clubfoot

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    control

    experiment

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    The adduction of foot.
    Measure the angle of foot adduction
    The adduction of foot.
    Measure the angle of foot adduction

    Secondary Outcome Measures

    The dorsiflextion of ankle.
    Measure the angle of ankle dorsiflextion
    The dorsiflextion of ankle.
    Measure the angle of ankle dorsiflextion

    Full Information

    First Posted
    September 21, 2019
    Last Updated
    December 26, 2019
    Sponsor
    Guangzhou Women and Children's Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04212663
    Brief Title
    A Study on the Treatment of Recurrent Clubfoot With the Tendon Release of Musculi Tibialis Posterior
    Official Title
    A Multicenter Study on the Treatment of Recurrent Clubfoot With the Tendon Release of Musculi Tibialis Posterior
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2020 (Anticipated)
    Primary Completion Date
    February 1, 2020 (Anticipated)
    Study Completion Date
    September 25, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guangzhou Women and Children's Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Clubfoot
    Keywords
    Musculi tibialis posterior, Tendon release, Anterior tibial tendon transfer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Description
    receive the procure of Anterior tibial tendon transfer(TATT) + Achilles tendon lengthing + fascial release
    Arm Title
    experiment
    Arm Type
    Experimental
    Arm Description
    receive the procure of Anterior tibial tendon transfer(TATT) + Achilles tendon lengthing + fascial release+ The tendon release of musculi tibialis posterior
    Intervention Type
    Procedure
    Intervention Name(s)
    The tendon release of musculi tibialis posterior
    Intervention Description
    To release the tendon of musculi tibialis posterior.
    Intervention Type
    Procedure
    Intervention Name(s)
    Anterior tibial tendon transfer(TATT)
    Intervention Description
    To transfer the the tendon of anterior tibial from the navicular to the third cuneiform.
    Intervention Type
    Procedure
    Intervention Name(s)
    Achilles tendon lengthing
    Intervention Description
    To lengthen the achilles tendon by using two incisions.
    Intervention Type
    Procedure
    Intervention Name(s)
    Fascial release
    Intervention Description
    To cut off the metatarsal fascia in the middle part.
    Primary Outcome Measure Information:
    Title
    The adduction of foot.
    Description
    Measure the angle of foot adduction
    Time Frame
    Six months after the operation
    Title
    The adduction of foot.
    Description
    Measure the angle of foot adduction
    Time Frame
    1 year after operation
    Secondary Outcome Measure Information:
    Title
    The dorsiflextion of ankle.
    Description
    Measure the angle of ankle dorsiflextion
    Time Frame
    Six months after the operation
    Title
    The dorsiflextion of ankle.
    Description
    Measure the angle of ankle dorsiflextion
    Time Frame
    1 year after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: Symptomatic recurrent clubfoot Tarsal fusion Rigid recurrent clubfoot

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs