跳至主要内容
临床试验/CTRI/2024/08/073123
CTRI/2024/08/073123尚未招募不适用

Accelerated versus Standard Ponseti Cast in the Management of Idiopathic Congenital Talipes Equinovarus at a Tertiary Care Centre: A Comparative Study

Archit Garg1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年9月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
To compare the TIME TAKEN FOR COMPLETE deformity correction (Pirani score of zero) of idiopathic Congenital Talipes Equinovarus by Accelerated Ponseti method with that of Standard Ponseti method in children less than 2 years

研究概览

简要总结

Congenital Talipes Equinovarus Varus (CTEV) also known as clubfoot is one of the most common and complex developmental pediatric foot deformity with a reported incidence of 0.5-2 cases per 1000 live births (1).With a male to female ratio of 2:1, bilateral deformity is seen in around 50% of cases. In unilateral cases, the right foot is the most commonly affected than left foot (2).

CTEV is characterized by adduction, varus, equinus, and cavus deformities of the foot. The first written record of clubfoot treatment is found in the works of Hippocrates from around 400 BC. Hippocrates was the first to advocate orthopedic treatment of clubfoot by gentle manipulation and bandaging (3). Nicholas Andry (1743) in his “Orthopaedia” called the deformity as pedes equinus resembling the foot of horse. Although the exact etiology of CTEV remains debated, the consensus favors multiple genetic and environmental risk factors that play varying levels of contributing roles in the clinical manifestations of CTEV (4).

In the 1960s, Dr. Ignacio Ponseti devised his method of conservative treatment of CTEV, which started from the age of one day and was based on the fundamentals of kinematics and pathoanatomy of the deformity and successfully realigning the clubfoot in infants without any extensive and major surgeries (5). The Conventional Ponseti method uses serial application of weekly above knee plaster casts to gradually correct the deformity, using a strictly defined sequence of molded plaster changes. The last deformity to be corrected is equinus, which often requires a Percutaneous Tendoachilles tenotomy followed by a final plaster. This final plaster is removed after three weeks and foot abduction braces are given to the child which are to be worn for twenty-three hours per day for three months and thereafter for twelve hours at night, till the age of three years. Classic Ponseti method involves weekly plaster change with gradual abduction of foot (6). In accelerated Ponseti method, the manipulation method remains the same but plaster is changed two or three times a week (7).

This study is being done with an aim to determine effectiveness of a shorter duration of treatment which has obvious advantages in a country like India where parents have to travel long distances to bring their children for plaster changes and for follow up at health centre.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Day(s) 至 2.00 Year(s)(—)
性别
All

入选标准

  • All infants and toddlers under the age of two with idiopathic club foot.

排除标准

  • Children with other coexisting congenital bone or other system anomalies
  • History of previous conservative or surgical intervention.

结局指标

主要结局

To compare the TIME TAKEN FOR COMPLETE deformity correction (Pirani score of zero) of idiopathic Congenital Talipes Equinovarus by Accelerated Ponseti method with that of Standard Ponseti method in children less than 2 years

时间窗: Deformity correction of idiopathic Congenital Talipes Equinovarus by Accelerated Ponseti method will be checked after every 5 days and by Standard Ponseti method after every 1 week

次要结局

未报告次要终点

研究者

发起方
Archit Garg
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Archit Garg

Armed Forces Medical College

研究点 (1)

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