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临床试验/NCT06377670
NCT06377670尚未招募不适用

Study of Functional and Aesthetic Outcomes After Wassel IV Thumb Duplication Surgery in Pediatric Population, With a Follow-up of at Least One Year

University Hospital, Grenoble0 个研究点目标入组 30 人开始时间: 2024年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
主要终点
Functional and Aesthetic Outcomes

研究概览

简要总结

The purpose of this study is to evaluate the functional and aesthetic outcomes in children with Wassel IV thumb duplication

详细描述

Wassel IV thumb duplication is a congenital hand anomaly characterized by the presence of two adjacent thumbs. This condition has significant functional and aesthetic implications.

Previous studies have highlighted the complexity of the surgical management of Wassel IV thumb duplication, underscoring the need for an individualized approach for each case. Early interventions are often recommended to optimize long-term functional and aesthetic outcomes.

The field of study for evaluating these outcomes focuses on the analysis of the medium and long-term consequences of surgical interventions in children with this malformation. Evaluation criteria may include hand functionality, thumb mobility, overall aesthetics, and other aspects relevant to the quality of life of the affected pediatric patients. This medium and long-term approach offers crucial insights for refining treatment protocols and improving the overall management of this condition.

研究设计

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

入排标准

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

入选标准

  • Confirmed diagnosis of Wassel IV thumb duplication
  • Pediatric patients aged between 1 and 18 years
  • Minimum of one year post-operative follow-up
  • Availability of radiographic, photographic, and medical data
  • Regular post-operative medical follow-up with the referring surgeon
  • Legal guardian and patient consent (non-opposition) to participate in the study

排除标准

  • Subjects under guardianship or deprived of liberty
  • Opposition from legal guardians or from the patient to participate in the study

结局指标

主要结局

Functional and Aesthetic Outcomes

时间窗: Up to one year post-surgery for the primary outcome measure time frame

Evaluation of functional and aesthetic outcomes using the Japanese Society for Surgery of the Hand (JSSH) scoring method. Functional outcomes include thumb mobility and function scored out of 10 points, and aesthetic outcomes include overall thumb appearance scored out of 14 points. The minimal and worst score is 0, the maximal and best score is 30.

次要结局

  • Immobilization Method Analysis(One year post-operative, to align with the follow-up period of the primary outcome measure.)
  • Comparison of Surgical Techniques(One year post-operative, to align with the follow-up period of the primary outcome measure.)
  • Efficacy of Skin Flap Types(One year post-operative, to align with the follow-up period of the primary outcome measure.)
  • Preoperative Angle Decision Model(One year post-operative, to align with the follow-up period of the primary outcome measure.)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

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