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

Sponsor
Guangzhou Women and Children's Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT04212663
Collaborator
(none)
80
Enrollment
2
Arms
19.8
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: The tendon release of musculi tibialis posterior
  • Procedure: Anterior tibial tendon transfer(TATT)
  • Procedure: Achilles tendon lengthing
  • Procedure: Fascial release
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Multicenter Study on the Treatment of Recurrent Clubfoot With the Tendon Release of Musculi Tibialis Posterior
Anticipated Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Feb 1, 2020
Anticipated Study Completion Date :
Sep 25, 2021

Arms and Interventions

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: The tendon release of musculi tibialis posterior
To release the tendon 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.

Outcome Measures

Primary Outcome Measures

  1. The adduction of foot. [Six months after the operation]

    Measure the angle of foot adduction

  2. The adduction of foot. [1 year after operation]

    Measure the angle of foot adduction

Secondary Outcome Measures

  1. The dorsiflextion of ankle. [Six months after the operation]

    Measure the angle of ankle dorsiflextion

  2. The dorsiflextion of ankle. [1 year after operation]

    Measure the angle of ankle dorsiflextion

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Guangzhou Women and Children's Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hongwen Xu, The director of pediatric orthopedic depatment, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier:
NCT04212663
Other Study ID Numbers:
  • GuangzhouWCMC-002
First Posted:
Dec 27, 2019
Last Update Posted:
Dec 27, 2019
Last Verified:
Dec 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hongwen Xu, The director of pediatric orthopedic depatment, Guangzhou Women and Children's Medical Center
Musculi tibialis posterior
Tendon release
Anterior tibial tendon transfer
Additional relevant MeSH terms:
Clubfoot
Talipes
Equinus Deformity
Recurrence

Study Results

No Results Posted as of Dec 27, 2019