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

December 26, 2019 updated by: Hongwen Xu, Guangzhou Women and Children's Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control
receive the procure of Anterior tibial tendon transfer(TATT) + Achilles tendon lengthing + fascial release
Procedure: Anterior tibial tendon transfer(TATT)
To transfer the the tendon of anterior tibial from the navicular to the third cuneiform.
Procedure: Achilles tendon lengthing
To lengthen the achilles tendon by using two incisions.
Procedure: Fascial release
To cut off the metatarsal fascia in the middle part.
Experimental: experiment
receive the procure of Anterior tibial tendon transfer(TATT) + Achilles tendon lengthing + fascial release+ The tendon release of musculi tibialis posterior
Procedure: Anterior tibial tendon transfer(TATT)
To transfer the the tendon of anterior tibial from the navicular to the third cuneiform.
Procedure: Achilles tendon lengthing
To lengthen the achilles tendon by using two incisions.
Procedure: Fascial release
To cut off the metatarsal fascia in the middle part.
Procedure: The tendon release of musculi tibialis posterior
To release the tendon of musculi tibialis posterior.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The adduction of foot.
Time Frame: Six months after the operation
Measure the angle of foot adduction
Six months after the operation
The adduction of foot.
Time Frame: 1 year after operation
Measure the angle of foot adduction
1 year after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The dorsiflextion of ankle.
Time Frame: Six months after the operation
Measure the angle of ankle dorsiflextion
Six months after the operation
The dorsiflextion of ankle.
Time Frame: 1 year after operation
Measure the angle of ankle dorsiflextion
1 year after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Women and Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

September 25, 2021

Study Registration Dates

First Submitted

September 21, 2019

First Submitted That Met QC Criteria

December 26, 2019

First Posted (Actual)

December 27, 2019

Study Record Updates

Last Update Posted (Actual)

December 27, 2019

Last Update Submitted That Met QC Criteria

December 26, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GuangzhouWCMC-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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