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Ultrasound-Guided Repeated Saline Injections to Prevent and Treat Tendon Adhesions After Hand Tendon Repair

2026年10月15日 更新者：Kai Wang

A Prospective Randomized Controlled Trial of Ultrasound-Guided Repeated Normal Saline Injections for Preventing and Treating Tendon Adhesion

Scar tissue can form around a repaired tendon and restrict finger movement. This study will evaluate whether repeated ultrasound-guided normal saline injections, in addition to standard postoperative rehabilitation, can help prevent and treat tendon adhesion after surgical repair of zone II flexor tendon injuries.

The study is a prospective, single-center, randomized controlled trial involving 80 adults aged 18 to 60 years with a zone II flexor tendon rupture in the index, middle, ring, or little finger. Participants will be assigned to one of two groups, with 40 participants in each group. Participants in both groups will receive the same standard postoperative rehabilitation treatment, including early active finger mobilization. In addition to this rehabilitation, the experimental group will receive ultrasound-guided percutaneous injections of 1 mL of normal saline at the tendon adhesion site on postoperative days 7, 14, and 21. The control group will receive standard postoperative rehabilitation alone, without postoperative normal saline injections.

The primary outcome is total active motion of the repaired finger at 3 months after surgery. Finger movement, pain, hand function, postoperative finger infection, and tendon rupture will also be assessed at the scheduled follow-up visits.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This prospective, single-center, randomized controlled trial will be conducted at Shanghai Sixth People's Hospital to evaluate the effectiveness and safety of repeated ultrasound-guided normal saline injections as an adjunct to standard postoperative rehabilitation for preventing and treating tendon adhesion after flexor tendon repair.

A total of 80 participants aged 18 to 60 years with a zone II flexor tendon rupture in the index, middle, ring, or little finger who are scheduled to undergo tendon repair will be enrolled. Participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group.

Participants in both groups will undergo tendon repair and receive the same standard postoperative rehabilitation treatment, including early active finger mobilization. In addition to standard rehabilitation, participants in the experimental group will receive ultrasound-guided percutaneous injections of 1 mL of normal saline at the identified tendon adhesion site on postoperative days 7, 14, and 21. Dynamic ultrasound imaging will be used to observe the distribution of normal saline in the tendon repair region. Participants in the control group will receive standard postoperative rehabilitation alone, without postoperative normal saline injections.

Follow-up assessments will be performed at 6 weeks and 3 months after surgery. The primary outcome is total active motion (TAM) at 3 months after surgery, expressed in degrees and analyzed as a continuous variable. Secondary outcomes include TAM at 6 weeks and visual analog scale (VAS) pain scores, Michigan Hand Outcomes Questionnaire (MHQ) scores, postoperative finger infection rates, and tendon rupture rates at 6 weeks and 3 months.

Safety assessments will include physical examination, vital signs, complete blood count, C-reactive protein, and erythrocyte sedimentation rate. Adverse events will be recorded and evaluated throughout the study.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

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

学习地点

  • 中国
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200233
        • 招聘中
        • Shanghai sixth people's hospital
        • 接触：

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

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age 18 to 60 years.
  2. Zone II flexor tendon rupture in the index, middle, ring, or little finger.
  3. Scheduled to undergo tendon repair surgery.

Exclusion Criteria:

  1. Concomitant irreparable vascular and/or nerve injury.
  2. History of diabetes mellitus.
  3. History of treatment with nonsteroidal anti-inflammatory drugs.
  4. History of cardiac insufficiency.
  5. History of hematologic disease.
  6. History of hepatic or renal dysfunction.
  7. History of rheumatic or autoimmune disease.
  8. History of chemotherapy or radiotherapy.
  9. History of steroid treatment.
  10. Pregnancy.
  11. Concurrent participation in another clinical trial.

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

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Ultrasound-Guided Repeated Normal Saline Injections

Participants will undergo flexor tendon repair and receive ultrasound-guided percutaneous injections of 1 mL of normal saline at the identified tendon adhesion site on postoperative days 7, 14, and 21.
程序：Ultrasound-Guided Repeated Normal Saline Injections

Normal saline will be administered by ultrasound-guided percutaneous injection at the identified tendon adhesion site after flexor tendon repair. Each injection will contain 1 mL of normal saline. Injections will be performed on postoperative days 7, 14, and 21.
无干预：No Postoperative Normal Saline Injection

Participants will undergo flexor tendon repair without postoperative normal saline injections.

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
Total Active Motion at 3 Months After Surgery
大体时间：3 months after surgery

Total active motion (TAM) of the surgically repaired finger, expressed in degrees and analyzed as a continuous measure of joint motion.
3 months after surgery

次要结果测量

结果测量
措施说明
大体时间
Total Active Motion at 6 Weeks After Surgery
大体时间：6 weeks after surgery

Total active motion (TAM) of the surgically repaired finger, expressed in degrees and analyzed as a continuous measure of joint motion.
6 weeks after surgery
Visual Analog Scale Pain Score
大体时间：6 weeks and 3 months after surgery

Pain intensity will be assessed using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity and a worse outcome.
6 weeks and 3 months after surgery
Michigan Hand Outcomes Questionnaire Score
大体时间：6 weeks and 3 months after surgery

Hand function will be assessed using the Michigan Hand Outcomes Questionnaire (MHQ). The overall score ranges from 0 to 100, with higher scores indicating better hand function and a better outcome.
6 weeks and 3 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

Kai Wang

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10月1日

初级完成 (估计的)

2027年9月30日

研究完成 (估计的)

2027年9月30日

研究注册日期

首次提交

2026年9月30日

首先提交符合 QC 标准的

2026年9月30日

首次发布 (实际的)

2026年10月6日

研究记录更新

最后更新发布 (实际的)

2026年10月20日

上次提交的符合 QC 标准的更新

2026年10月15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

其他研究编号

  • 2025-119(1)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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