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临床试验/NCT06266208
NCT06266208已完成不适用

Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte Associated With Onychocryptosis: Correlation With Radiology.

Fundación Universidad Católica de Valencia San Vicente Mártir4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
4
主要终点
Nail-phalange distance

研究概览

简要总结

This study will evaluate the usefulness of ultrasonography in detecting dorsal osteophytes associated with claw nails compared to radiographs. The hypothesis will be that the larger the size of the osteophyte, the greater the nail curvature.

Nail curvature and osteophyte height will be measured in patients with clamp nails. Nail-phalange distance will also be measured with radiography and ultrasonography.

The investigators to find a positive correlation between nail curvature and osteophyte height. Furthermore, a strong agreement is expected between both imaging techniques to measure nail-phalange distance.

Ultrasonography could constitute a safe and effective alternative to radiology for detecting dorsal osteophytes in claw nails, especially in mild cases, follow-ups or young patients.

详细描述

Main objective:

The investigators aim to explore the possible relationship between the degree of dorsal curvature of the nail plate and the height of the dorsal osteophyte in subungual exostosis patients before and after surgery.

Secondary objectives:

The investigators will compare the distance between the nail surface and the dorsal cortex of the distal phalanx using plain radiographs and high-resolution ultrasonography.

Materials and Methods:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical and radiological diagnosis of claw nail in at least one toe.
  • Pain associated with claw nail for at least 1 month.

排除标准

  • Pregnancy or breastfeeding
  • Previous trauma or surgery on the affected toe
  • Systemic diseases such as diabetes mellitus, renal insufficiency, rheumatoid arthritis
  • Current or previous treatment for ingrown toenail within the last year
  • Severe digital deformities (e.g. Hallux Valgus, hammer toe, claw toe)

结局指标

主要结局

Nail-phalange distance

时间窗: Pre-surgery, 2 months, 6 months.

The measurement of the minimum distance between the dorsal cortex of the distal phalanx and the ventral aspect of the nail of the first toe will be done using lateral radiographs and longitudinal ultrasounds. Lateral radiographs capture toe images from a side angle to determine the spatial relationship between the two points, with measurements expressed in millimeters. Longitudinal ultrasounds provide real-time images to visualize this relationship, with the ultrasound transducer placed along the toe. Both methods offer vital insights into toe anatomy for medical purposes like assessing deformities, tracking injuries, or planning surgeries.

次要结局

  • Nail Curvature Index(Pre-surgery, 1 months)
  • Thickness of the nail plate(Pre-surgery, 1 months)
  • Dorsal Osteophyte Height(Pre-surgery, 1 months)

研究者

发起方
Fundación Universidad Católica de Valencia San Vicente Mártir
申办方类型
Other
责任方
Sponsor

研究点 (4)

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