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临床试验/NCT03378206
NCT03378206Unknown不适用

Comparison of the Outcomes of the Treatment of Semiepiphysiodesis Using Hinged and Conventional 8-figure Plates: A Randomized Controlled Clinical Trial

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 80 人开始时间: 2018年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
主要终点
The complications.

研究概览

简要总结

To assess the therapeutic effect of hinged 8-figure plate by comparing with the traditional 8-figure plate through a randomized controlled clinical trial by assessing the differences between preoperative and postoperative data.

The hypothesis is that the hinged 8 plate provides low complications that this treatment is as good as the traditional one.

详细描述

Angular deformities of the lower limb is major clinical problems encountered in pediatric orthopedics. Deformities can be either valgus or varus and most commonly affect the knee joint, which may result in patella dislocation, gait instability and serious impact on the appearance and function of the lower limbs. Biomechanical studies and gait analysis found that genu varus increased medial articular surface pressure of the knee, while genu valgus increased lateral articular surface pressure, and both of them are the risk factors for osteoarthritis. Surgical treatment techniques include osteotomy and hemiepipysidesis. Osteotomy surgery is the gold standard for severe angular deformity or epiphyseal closed patients, but it was associated with lots of complications, including osteofascial compartment syndrome, neurovascular injury, deep soft tissue infection, nonunion and requiring a long recovery time. While, for patients whose epiphyseal is not closed, the traditional 8 plate hemiepipysidesis has fewer complications. However, it showed some problems in clinical applications, such as steel plate or screw broken. The investigators designed a new hinged 8 plate, which has two arms and a built-in hinge. Based on the previous studies, investigators designed the rotation of the two arms ranged from 155° to 170° to better fit the contour of the physis in all stages of angular correction. That automatic change can also disperse repeated stress on the surface of periosteum and perichondrium during walking. The plate had been tested on animal models that the use of the hinged plate and screw system may be a more reliable technique with minimal complications for correction of angular deformities of the lower limb.

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
None

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic genu valgus or varum
  • Without any treatment
  • lower limb mechanical axis over the tibial plateau in the range of 1/2;
  • Epiphyseal not yet closed, with more than 12 months of growth potential

排除标准

  • Physiological genu valgus or varum
  • Epiphyseal have closed or no growth potential
  • Pathological limb deformity(Blount disease, inflammation,trauma)
  • Other causes of lower limb angular deformity.
  • With surgical contraindications

研究组 & 干预措施

Hinged 8-figure plate

Experimental

Hinged 8-figure plate is a novel devise that has modifications in order to improve the treatment effect of conventional 8-figure plate. This arm will be used to verify the effectiveness and feasibility of the modification.

干预措施: hinged 8-figure plate (Device)

conventional 8-figure plate

Active Comparator

Conventional 8-figure plate is widespread method to treat genu varum and valgus. This arm, as a comparator, will be the control group to verify the feasibility of the novel hinged 8-figure plate.

干预措施: conventional 8-figure plate (Device)

结局指标

主要结局

The complications.

时间窗: 2 years

Surgery related complications including osteofascial compartment syndrome, neurovascular injury, deep soft tissue infection and so on will be observed until correction of deformity.

次要结局

  • The corrective rates of medial slope angle.(2 years)
  • The corrective of Mechanical lateral distal femoral angle.(2 years)
  • The movement of two arms of the hinged plate.(2 years)
  • The residual stress on the implants.(2 years)

研究者

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

Ziming Zhang

Deputy director of Department of Pediatric Orthopedics

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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