临床试验/CTRI/2024/05/067655

CTRI/2024/05/067655已完成不适用

Comparison of Medial Hamstring Lengthening with Combined Hamstring Lengthening and Semi-tendinosus Transfer for treatment of Knee Flexion Deformity in Cerebral Palsy

Lady Hardinge Medical College and Associated Hospitals1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2024年6月3日最近更新: 2025年9月29日

试验速览

阶段: 不适用
状态: 已完成
发起方: Lady Hardinge Medical College and Associated Hospitals
入组人数: 30
试验地点: 1
主要终点: Proportion of patients with completely corrected knee flexion deformity

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The trial is a comparison of 2 standard surgical procedures for knee flexion deformity correction - Medial Hamstring lengthening, compared with Combined Medial Hamstring lengthening with Semi-tendinosus transfer. The aim of the study is to compare the post-operative outcomes of both the surgeries to aid orthopedic surgeons in choosing one procedure over the other. The primary and secondary outcome variables will be assesed at a period of 3 weeks, 3 months, and 6 months post-op and analysed.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Investigator Blinded

入排标准

年龄范围: 7.00 Year(s) 至 12.00 Year(s)（—）
性别: All

入选标准

•Patients aged 7-12 years old, diagnosed with spastic hemiplegic/diplegic Cerebral Palsy with Knee flexion deformity (of all degrees of severity) of unilateral/bilateral knees showing flexed knee gait.

排除标准

•Patients with GMFCS Score greater than 3, Patients with history of past surgical intervention for knee deformity correction, Patients with cognitive disorders or syndromes.

结局指标

主要结局

Proportion of patients with completely corrected knee flexion deformity

时间窗: 3 weeks, 3 months, 6 months post-op

次要结局

Change in flexion deformity(3 weeks, 3 months, 6 months post-op)
Change in popliteal angle(3 weeks, 3 months, 6 months post-op)
Change in bilateral popliteal angle
Post-op Anterior Pelvic Tilt(3 weeks, 3 months, 6 months post-op)
Change in GMFCS Score(3 weeks, 3 months, 6 months post-op)
Improvement in gait(3 weeks, 3 months, 6 months post-op)

研究者

发起方

Lady Hardinge Medical College and Associated Hospitals

申办方类型

Government medical college

责任方

Principal Investigator

主要研究者

Dr Utkarsh Singhal

Lady Hardinge Medical College and Associated Hospitals, New Delhi

研究点 (1)

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