NCT06389253尚未招募不适用
Subtalar Extra-articular Screw Arthroereisis: How Does the Screw Work
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Primary Endpoint (%)
研究概览
简要总结
The aim of the study is to investigate the effect of subtalar extra-articular calcaneo-stop screw on the proprioceptive and nociceptive pathways of the ankle before and after implantation. The hypothesis of the study is that an increased number of receptors related to proprioception will be detected in the sinus tarsi.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study Group:
- •Patients aged 14 years old and above that will remove the calcaneo stop screw, in place for at least 3 years after the implant, will be recruited
- •Patients willing and able to give informed consent for the participation in the study. For underage patients, a parent/legal representative will give consent for the participation in the study.
- •Male and female patients in fertile age can be recruited.
- •Control Group:
- •Syndromic patients
- •Previous foot malformation (synostosis, congenital clubfoot)
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
排除标准
- •Control Group:
- •Syndromic patients
- •Previous foot malformation (synostosis, congenital clubfoot)
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- •Study Group:
- •Patients suffering from post-operative complications
- •Syndromic patients
- •Previous foot malformation (synostosis, congenital clubfoot)
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
结局指标
主要结局
Primary Endpoint (%)
时间窗: Time 0 (baseline)
Percentage of patients presenting at least one proprioceptive fibers in the pericapsular tissue
次要结局
- Secondary Endpoint(Time 0 (baseline))
研究者
Professor Giacomo Placella
Professor
Università Vita-Salute San Raffaele
研究点 (2)
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