此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Open vs. Ultrasound-Guided Carpal Tunnel Release

2026年9月6日 更新者：AUVA General Trauma Hospital Salzburg

Prospective Multicenter Trial Comparing Open Surgical Decompression Versus Minimally Invasive Ultrasound-Guided Carpal Tunnel Release

Carpal Tunnel Syndrome (CTS) is the most prevalent entrapment neuropathy. Open Surgical Carpal Tunnel Release (OSCTR) remains the gold standard, while minimally invasive Ultrasound-Guided Carpal Tunnel Release (USGCTR) offers potential advantages including reduced postoperative morbidity and faster recovery. This prospective, multicenter observational cohort study compares the clinical outcomes, patient-reported outcomes, and socioeconomic impact of USGCTR versus OSCTR. A total of 200 patients, with 100 patients per cohort, will be included. Patient assignment is based on the participating center's standard of care. Follow-up assessments are performed preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months after surgery.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Carpal Tunnel Syndrome (CTS) is the most common compression neuropathy of the median nerve. Open Surgical Carpal Tunnel Release (OSCTR) has been established as the clinical gold standard. However, the procedure is associated with a palmar incision and may result in scar pain, including pillar pain, and delayed return to manual activities.

Ultrasound-Guided Carpal Tunnel Release (USGCTR) is a minimally invasive technique that permits division of the flexor retinaculum under continuous sonographic visualization through a minimal incision at the distal forearm or wrist crease. Potential advantages include avoidance of a painful scar in the load-bearing area of the hand and potentially faster recovery.

The study aims to compare functional recovery and symptom relief following OSCTR versus USGCTR. Secondary objectives include comparison of postoperative pain, subjective outcome, return to work, patient satisfaction, and complication rates.

This is a prospective, multicenter observational cohort study. Patients are not randomized. Assignment to the two cohorts is determined by the participating treatment center and its respective standard procedure. Patients choose the treatment center based on referral by their previously treating neurologist or on personal information. The study team does not influence this decision. Both procedures are established standard procedures routinely performed at the respective institutions.

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 奥地利
      • Salzburg、奥地利、5010
        • 招聘中
        • AUVA General Trauma Hospital Salzburg
        • 接触：
        • 接触：
        • 副研究员：
          • Christoph Hirnsperger, Dr.
        • 首席研究员：
          • Alexander Paszicsnyek, Dr.
        • 副研究员：
          • Thomas Hausner, Prim. Priv. Doz. Dr.
      • Salzburg、奥地利、5020
        • 招聘中
        • University Institute of Radiology, Paracelsus Medical Private University Salzburg
        • 接触：
        • 接触：
        • 副研究员：
          • Klaus Hergan, Prof. Dr.
        • 首席研究员：
          • Christoph Knapitsch, Dr.
        • 副研究员：
          • Nikolaos Schörghofer, Dr.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

概率样本

研究人群

Participants will be recruited during routine clinical consultations at the outpatient clinics of the participating centers. Patients fulfilling the inclusion criteria will be informed about the study by their treating physicians. Participation is voluntary and does not affect the quality of medical care.

描述

Inclusion Criteria:

  • Electrophysiologically verified Carpal Tunnel Syndrome by EMG/nerve conduction studies, with the examination not older than 6 months at the time of inclusion.
  • Previous documented and exhausted conservative treatment
  • Existing indication for surgery that has been discussed with the patient and the patient's explicit wish to undergo surgical treatment.
  • Ability to provide informed consent and written informed consent
  • Age ≥18 years.

Exclusion Criteria:

  • Previous surgery at the affected location or revision procedures.
  • Pre-existing nerve lesions of the upper extremity, including traumatic transections or proximal injuries.
  • Manifest polyneuropathy.
  • Foreseeable loss to follow-up, for example inability to contact the participant or insufficient compliance, before the critical 3-month follow-up.
  • Age under 18 years.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Open Surgical Carpal Tunnel Release (OSCTR)
Patients undergoing open surgical decompression at AUVA Unfallkrankenhaus Salzburg as the standard procedure of the participating center.
程序：Open Surgical Carpal Tunnel Release (OSCTR)
Open surgical decompression of the carpal tunnel (OSCTR) is performed at UKH Salzburg as the established standard surgical treatment for carpal tunnel syndrome. The procedure involves open surgical release of the flexor retinaculum. Intraoperative findings and immediate complications are documented.
Ultrasound-Guided Carpal Tunnel Release (USGCTR)
Patients undergoing minimally invasive ultrasound-guided carpal tunnel release at the University Institute of Radiology, Paracelsus Medical Private University Salzburg, as the standard procedure of the participating center.
程序：Ultrasound-Guided Carpal Tunnel Release (USGCTR)
Ultrasound-guided carpal tunnel release (USGCTR) is performed at the University Institute of Radiology of the Paracelsus Medical Private University. The minimally invasive procedure involves release of the flexor retinaculum under continuous sonographic visualization through a minimal incision at the distal forearm or wrist crease. Intraoperative findings and immediate complications are documented.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score
大体时间：Baseline to 3 months postoperatively
Mean difference in the change in the Boston Carpal Tunnel Questionnaire (BCTQ) score, combining the Symptom Severity Scale and Functional Status Scale, from the preoperative assessment (T0) to the 3-month postoperative assessment (T3).
Baseline to 3 months postoperatively

次要结果测量

结果测量
措施说明
大体时间
Pain Intensity - Visual Analog Scale (VAS), 0-10
大体时间：Preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively
Change in pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10.
Preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively
Subjective Hand Function - Single Assessment Numeric Evaluation (SANE), 0-100%
大体时间：Preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively
Subjective hand function measured using the Single Assessment Numeric Evaluation (SANE), ranging from 0 to 100%.
Preoperatively and at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively
Time to Full Return to Work - Number of Days After Surgery
大体时间：Up to 3 months postoperatively
Number of days from surgery until full return to work.
Up to 3 months postoperatively
Postoperative Complications - Frequency of Wound Infection, Persistent Numbness, and Revision Surgery
大体时间：Within 12 months after surgery
Frequency of wound infections, persistent numbness, or required revision procedures.
Within 12 months after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AUVA General Trauma Hospital Salzburg

合作者

Paracelsus Medical University
Salzburger Landeskliniken

调查人员

  • 学习椅：Thomas Hausner, Prim. Priv. Doz. Dr.、AUVA General Trauma Hospital Salzburg

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2028年6月30日

研究完成 (估计的)

2028年7月1日

研究注册日期

首次提交

2026年9月1日

首先提交符合 QC 标准的

2026年9月6日

首次发布 (实际的)

2026年9月11日

研究记录更新

最后更新发布 (实际的)

2026年9月11日

上次提交的符合 QC 标准的更新

2026年9月6日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CTS_USvsOS
  • 1070/2026 (其他赠款/资助编号：Ethic committee Salzburg)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅