NCT04212663

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 27, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2021

Completed
Last Updated

December 27, 2019

Status Verified

December 1, 2019

Enrollment Period

Same day

First QC Date

September 21, 2019

Last Update Submit

December 26, 2019

Conditions

Recurrent Clubfoot

Keywords

Musculi tibialis posteriorTendon releaseAnterior tibial tendon transfer

Outcome Measures

Primary Outcomes (2)

  • The adduction of foot.

    Measure the angle of foot adduction

    Six months after the operation

  • The adduction of foot.

    Measure the angle of foot adduction

    1 year after operation

Secondary Outcomes (2)

  • The dorsiflextion of ankle.

    Six months after the operation

  • The dorsiflextion of ankle.

    1 year after operation

Study Arms (2)

control

PLACEBO COMPARATOR

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

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

experiment

EXPERIMENTAL

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 posteriorProcedure: Anterior tibial tendon transfer(TATT)Procedure: Achilles tendon lengthingProcedure: Fascial release

Interventions

The tendon release of musculi tibialis posteriorPROCEDURE

To release the tendon of musculi tibialis posterior.

experiment
Anterior tibial tendon transfer(TATT)PROCEDURE

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

controlexperiment
Achilles tendon lengthingPROCEDURE

To lengthen the achilles tendon by using two incisions.

controlexperiment
Fascial releasePROCEDURE

To cut off the metatarsal fascia in the middle part.

controlexperiment

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Symptomatic recurrent clubfoot
  • Tarsal fusion
  • Rigid recurrent clubfoot

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The director of pediatric orthopedic depatment

Study Record Dates

First Submitted

September 21, 2019

First Posted

December 27, 2019

Study Start

February 1, 2020

Primary Completion

February 1, 2020

Study Completion

September 25, 2021

Last Updated

December 27, 2019

Record last verified: 2019-12