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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04212663
Other study ID # GuangzhouWCMC-002
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date September 25, 2021

Study information

Verified date December 2019
Source Guangzhou Women and Children's Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date September 25, 2021
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender All
Age group 4 Years to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
The tendon release of musculi tibialis posterior
To release the tendon of musculi tibialis posterior.
Anterior tibial tendon transfer(TATT)
To transfer the the tendon of anterior tibial from the navicular to the third cuneiform.
Achilles tendon lengthing
To lengthen the achilles tendon by using two incisions.
Fascial release
To cut off the metatarsal fascia in the middle part.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Guangzhou Women and Children's Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary The adduction of foot. Measure the angle of foot adduction Six months after the operation
Primary The adduction of foot. Measure the angle of foot adduction 1 year after operation
Secondary The dorsiflextion of ankle. Measure the angle of ankle dorsiflextion Six months after the operation
Secondary The dorsiflextion of ankle. Measure the angle of ankle dorsiflextion 1 year after operation