跳至主要内容
临床试验/NCT04212663
NCT04212663Unknown不适用

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

Guangzhou Women and Children's Medical Center0 个研究点目标入组 80 人开始时间: 2020年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
主要终点
The adduction of foot.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Symptomatic recurrent clubfoot
  • •Tarsal fusion
  • •Rigid recurrent clubfoot

研究组 & 干预措施

control

Placebo Comparator

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

干预措施: Anterior tibial tendon transfer(TATT) (Procedure)

control

Placebo Comparator

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

干预措施: Achilles tendon lengthing (Procedure)

control

Placebo Comparator

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

干预措施: Fascial release (Procedure)

experiment

Experimental

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

干预措施: The tendon release of musculi tibialis posterior (Procedure)

experiment

Experimental

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

干预措施: Anterior tibial tendon transfer(TATT) (Procedure)

experiment

Experimental

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

干预措施: Achilles tendon lengthing (Procedure)

experiment

Experimental

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

干预措施: Fascial release (Procedure)

结局指标

主要结局

The adduction of foot.

时间窗: 1 year after operation

Measure the angle of foot adduction

The adduction of foot.

时间窗: Six months after the operation

Measure the angle of foot adduction

次要结局

  • The dorsiflextion of ankle.(1 year after operation)
  • The dorsiflextion of ankle.(Six months after the operation)

研究者

发起方
Guangzhou Women and Children's Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hongwen Xu

The director of pediatric orthopedic depatment

Guangzhou Women and Children's Medical Center

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