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临床试验/NCT07375134
NCT07375134已完成不适用

Evaluation of the Relationship Between Flexor Retinacular Ligament Thickness and the Development of Heel Pain Syndrome After Carpal Tunnel Surgery.

GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年10月22日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
144
试验地点
1
主要终点
Compare the intraoperative measurement of flexor retinacular ligament thickness between the two groups of patients operated on for carpal tunnel syndrome by the same surgeon using the Chow technique (with and without hand heel syndrome).

研究概览

简要总结

Numerous studies have examined the relationship between carpal tunnel syndrome and the thickness of the flexor retinacular ligament. This varies along the course of the median nerve (the distal portion being the thickest) and increases with age. These studies have shown that the thickness of the ligament is greater in patients with carpal tunnel syndrome, without, however, demonstrating that it is related to the onset of this syndrome. According to Bartolomé-Villar, it may rather influence the onset of carpal pain.

The objective of this study is to determine whether a relationship exists between the thickness of the flexor retinacular ligament and the development of heel syndrome in the postoperative period for carpal tunnel syndrome.

详细描述

This is a prospective, longitudinal, single-center, open-label observational study conducted on a population of patients operated on for carpal tunnel syndrome.

This study does not alter patient care or the doctor-patient relationship. Evaluations take place during routinely scheduled consultations. The frequency of evaluations is consistent with standard postoperative follow-up.

研究设计

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

入排标准

年龄范围
18 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patient over 18 years of age
  • Patient who has been informed of the research and has not indicated their opposition to the use of their medical data
  • Patient who is a candidate for first-time carpal tunnel surgery

排除标准

  • Emergency surgery performed in a post-traumatic context
  • Mental impairment or any other reason that may hinder understanding or strict application of the protocol
  • Patient not affiliated with the French social security system
  • Patient under legal protection, guardianship, or curatorship
  • Patient already included in another therapeutic study protocol

研究组 & 干预措施

Patients with heel-of-hand syndrome 6 months after surgery for carpal tunnel syndrome

Patients with heel of the hand syndrome, 6 months after surgery for carpal tunnel syndrome (measurement of retinacular ligament thickness intraoperatively)

Patients without heel of the hand syndrome 6 months after surgery for carpal tunnel syndrome

Patients without heel of the hand syndrome, 6 months after surgery for carpal tunnel syndrome (measurement of retinacular ligament thickness intraoperatively)

结局指标

主要结局

Compare the intraoperative measurement of flexor retinacular ligament thickness between the two groups of patients operated on for carpal tunnel syndrome by the same surgeon using the Chow technique (with and without hand heel syndrome).

时间窗: perioperatively

Intraoperative measurement of flexor retinacular ligament thickness

次要结局

  • Assess the existence of other factors that may be related to the occurrence of hand heel syndrome (Spontaneous pain) according to the initial characteristics and follow-up data of patients with and without hand heel syndrome.(Baseline to six months after the surgery)
  • Assess the existence of other factors that may be linked to the occurrence of heel hand syndrome (Pain on palpation of the heel of the hand) based on initial characteristics and follow-up data, patients with and without hand heel syndrome(Baseline to six months after the surgery)
  • Assess the existence of other factors that may be linked to the occurrence of heel hand syndrome (Postoperative complications) based on follow-up data, patients with and without hand heel syndrome(Immediately after the intervention to six months postoperatory)

研究者

发起方
GCS Ramsay Santé pour l'Enseignement et la Recherche
申办方类型
Other
责任方
Sponsor

研究点 (1)

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