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临床试验/NCT04752995
NCT04752995已完成不适用

Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum: Improving the Technique and Managing Potential Complications.

Tanta University0 个研究点目标入组 70 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
主要终点
proximal medial tibial angle

研究概览

简要总结

Genu-varum is a common problem encountered in pediatric orthopedic. Correction of pathological deformity is mandatory to ensure normal load transfer through the knee. In this study, the investigators describe a new technique of osteotomy osteoclasis in order to evaluate if it is an effective and reliable method in management of infantile genu varum

详细描述

Seventy children with 122 legs suffering significant infantile genu-varum were treated by percutaneous osteotomy-osteoclasis technique. The mean age was 46 months. Genu varum was bilateral in 52 children and unilateral in 18 with a mean preoperative proximal medial tibial angle 66.67 ± 2.670. Under general anesthesia, transverse osteotomy osteoclasis was performed below the tibial tuberosity. Follow-up radiograph was done within the first post-operative week and then every two weeks to assess alignment and consolidation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
36 Months 至 52 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Infantile genu-varum
  • •PMTA≤70 not spontaneously corrected

排除标准

  • •Active rickets or other metabolic disease
  • •Patients in whom the femur or the joint is the main site of the deformity

研究组 & 干预措施

high tibial osteotomy

Other

Under general anesthesia, a one-cm vertical skin incision was done at the medial subcutaneous border of the tibia, one fingerbreadth below the tibial tuberosity. This was confirmed by intra-operative C-arm images. Longitudinal periosteal incision was done with minimal dissection. Incomplete medial transverse osteotomy including both anterior and posterior cortex was performed using drill bit or small thin osteotome.Osteotomy was completed manually by osteoclasis of the lateral cortex to provide postoperative stability by the preserved lateral periosteum. No fibular osteotomy was needed in the present study.

干预措施: osteotomy (Procedure)

结局指标

主要结局

proximal medial tibial angle

时间窗: one year

This angle was used for assessment of degree of deformity correction and to follow the presence of under- or over-correction

the posterior proximal tibial angle

时间窗: one year

confirm the absence or presence of any sagittal pro or recurvatum deformities(normal=81±2 degrees)

Self-Administered Patient Satisfaction Scale

时间窗: one year

the investigators asked the parents to rate their satisfaction on a scale from zero to 100 (100 to 75 very satisfied, \<75 to 50 somewhat satisfied, \<50 to 25 somewhat dissatisfied and \<25 dissatisfied).Those who were not satisfied are requested to explain the cause of dissatisfaction.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ahmed m. samy

assisstant professor

Tanta University

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