跳至主要内容
临床试验/NCT06091371
NCT06091371招募中不适用

Prospective Evaluation of Patients Undergoing Surgical Treatment for Arthrorisis of the Subtalar Joint With a Polymeric Endorthesis for the Treatment of Flexible Flatfoot in the Growth Age

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
55
试验地点
1
主要终点
Meary's angle

研究概览

简要总结

Arthrorisis of the subastragalus joint represents one of the surgical treatments for addressing flexible flatfoot, a condition caused by joint deformity. The device is designed to restore the correct joint relationships between the astragalus and calcaneus, with the goal of maintaining the new and proper joint alignment over time, typically allowing for bone remodeling along natural growth lines, usually within a few years.

Several implants and various variations of the procedure have been developed.There are currently no prospective studies that assess radiographic and clinical data over time. Therefore, the purpose of this study is to prospectively analyze the outcomes of surgical intervention using subastragalus arthrorisis with a polymeric endorthesis for the treatment of flexible flatfoot during the growth period in a consecutive series of 55 patients.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
8 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Idiopathic, flexible, symptomatic flatfoot
  • Patients aged between 8 and 14 years

排除标准

  • Joint laxity
  • Neuromuscular disorders
  • Neurological conditions
  • Traumatic sequelae
  • Iatrogenic flatfoot
  • Congenital flatfoot due to tarsal synostosis

结局指标

主要结局

Meary's angle

时间窗: After 72 months

Meary's angle is the angle between a line drawn along the longitudinal axes of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) on the lateral weight bearing X ray.

次要结局

  • AOFAS Score(After 72 months)

研究者

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

Antonio Mazzotti

Principal Investigator

Istituto Ortopedico Rizzoli

研究点 (1)

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