ChiCTR2300078897 版本V1.0 版本创建时间2023/12/20 16:38:56 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2300078897 

最近更新日期：

Date of Last Refreshed on：

2023-12-20 16:38:08 

注册时间：

Date of Registration：

2023-12-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

氨甲环酸局部应用于拇外翻术中的有效性和安全性的随机、阳性平行对照临床试验

Public title：

A randomized, positive, parallel-controlled clinical trial of the efficacy and safety of topical tranexamic acid in hallux valgus surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

氨甲环酸局部应用于拇外翻术中的有效性和安全性的随机、阳性平行对照临床试验

Scientific title：

A randomized, positive, parallel-controlled clinical trial of the efficacy and safety of topical tranexamic acid in hallux valgus surgery

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

王学文 

研究负责人：

孙宁 

Applicant：

Xuewen Wang 

Study leader：

Ning Sun 

申请注册联系人电话：

Applicant telephone：

+86 137 1622 8864

研究负责人电话：

Study leader's telephone：

+86 158 1139 1069

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

wangxuewen0923@163.com

研究负责人电子邮件：

Study leader's E-mail：

3475@jst-hosp.com.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

No.31 Xinjiekou East Street, Xicheng District, Beijing, China

研究负责人通讯地址：

No.31 Xinjiekou East Street, Xicheng District, Beijing, China

Applicant address：

No.31 Xinjiekou East Street, Xicheng District, Beijing, China

Study leader's address：

No.31 Xinjiekou East Street, Xicheng District, Beijing, China

申请注册联系人邮政编码：

Applicant postcode：

100035

研究负责人邮政编码：

Study leader's postcode：

100035

申请人所在单位：

首都医科大学附属北京积水潭医院

Applicant's institution：

Beijing Jishuitan Hospital, Capital Medical University

研究负责人所在单位：

首都医科大学附属北京积水潭医院

Affiliation of the Leader：

Beijing Jishuitan Hospital, Capital Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

积伦[K2023]第[369]号-00

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

首都医科大学附属北京积水潭医院伦理审查委员会

Name of the ethic committee：

Ethics Committee(seal)of Beijing Jishuitan Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2023-12-07 00:00:00

伦理委员会联系人：

王娜

Contact Name of the ethic committee：

Wang Na

伦理委员会联系地址：

首都医科大学附属北京积水潭医院新街口院区北楼四层，北京市西城区新街口东街31号

Contact Address of the ethic committee：

4th floor, North-Building, 31Xinjiekou East Street, Xicheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 5851 7080

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

首都医科大学附属北京积水潭医院足踝外科

Primary sponsor：

Foot and Ankle Surgery, Beijing Jishuitan Hospital, Capital Medical University

研究实施负责（组长）单位地址：

首都医科大学附属北京积水潭医院新街口院区，北京市西城区新街口东街31号

Primary sponsor's address：

No.31 Xinjiekou East Street, Xicheng District, Beijing, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

首都医科大学附属北京积水潭医院足踝外科

具体地址：

首都医科大学附属北京积水潭医院新街口院区，北京市西城区新街口东街31号

Institution
hospital：

Foot and Ankle Surgery, Beijing Jishuitan Hospital, Capital Medical University

Address：

No.31 Xinjiekou East Street, Xicheng District, Beijing, China

经费或物资来源：

自筹经费

Source(s) of funding：

Self-finance

Target disease：

Hallux valgus

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评估拇外翻术中（Chevron联合Akin截骨术）截骨面局部应用氨甲环酸在减少术后出血、缓解术后肿胀以及缓解术后疼痛中的早期疗效。  

Objectives of Study：

To evaluate the early efficacy of topical tranexamic acid applied to the osteotomy surface in hallux valgus surgery (Chevron combined with Akin osteotomy) in reducing postoperative bleeding, relieving postoperative swelling, and relieving postoperative pain.

药物成份或治疗方案详述：

本研究为一项随机对照实验，为探讨拇外翻术中局部应用氨甲环酸对于缓解术后短期内的肿胀及疼痛的效果，我科拟开展一项随机、阳性平行对照临床试验，探讨在拇外翻术中局部应用氨甲环酸对于缓解术后短期内的肿胀及疼痛的有效性和安全性。将就诊于我科，拟行Chevron联合Akin截骨术矫正拇外翻畸形的患者随机分为两组——对照组：术中关闭切口前于截骨面喷洒1g生理盐水；试验组：术中关闭切口前于截骨面喷洒1g氨甲环酸。对相应测量数据，应用统计学方法，分析患者术后短期内的肿胀程度与氨甲环酸的使用是否相关。 

Description for medicine or protocol of treatment in detail：

This study is a randomized, positive, parallel-controlled clinical trial to investigate the effectiveness and safety of topical tranexamic acid in hallux valgus surgery for the relief of postoperative swelling and pain in the short term. Patients attending our department for hallux valgus deformity correction by Chevron combined with Akin osteotomy were randomly divided into two groups - control group: 1g saline sprayed on the osteotomy surface before closing the incision during the operation; experimental group: 1g tranexamic acid sprayed on the osteotomy surface before closing the incision during the operation. Statistical methods were applied to the corresponding measurements to analyze whether the degree of swelling and pain in the short-term postoperative period of the patients was related to the use of tranexamic acid. 

纳入标准：

1）年龄≥16岁且≤70岁，男女不限； 2）符合中重度拇外翻诊断标准，术前拇外翻角(Hallux Valgus angle ，HVA）＞20°，跖骨间角(Intermetatarsal angle，IMA)＞13°； 3）经保守治疗3个月以上病情无明显改善； 4）患者既往未接受过同侧前足手术； 5）能够理解试验目的，自愿参加并签署知情同意书，可独立完成有效的问卷调查，并且愿意按照研究要求进行临床随访的患者； 6）无氨甲环酸以及氟比洛芬、氨酚羟考酮、曲马多等镇痛药物禁忌症。

Inclusion criteria

(1) Age ≥16 and ≤70 years old, male or female; (2) Meet the diagnostic criteria for moderate to severe hallux valgus, with preoperative Hallux Valgus angle (HVA) >20° and Intermetatarsal angle (IMA) >13°; (3) The patient's condition did not improve significantly after more than 3 months of conservative treatment; (4) The patients had not received ipsilateral forefoot surgery in the past; 5) Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, can independently complete a valid questionnaire, and are willing to follow up clinically according to the requirements of the study; (6) No contraindications to tranexamic acid and analgesic drugs such as flurbiprofen, aminophenol hydrocodone and tramadol.

排除标准：

1）既往接受过同侧前足手术； 2）既往有静脉血栓栓塞病史； 3）对氨甲环酸以及氟比洛芬、氨酚羟考酮、曲马多等镇痛药物禁忌症的患者； 4）伴有严重肝肾功能不全、心脑血管或其他严重疾病的患者； 5）糖尿病控制不佳的患者（糖化血红蛋白A1c＞8.0%） 6）第一跖趾关节有骨关节病及活动性感染者； 7）术中需同时联合其他足趾趾间关节、跖趾关节矫形术的患者； 8）正在参与其他药物或医疗器械临床试验且未达到其主要终点的患者； 9）研究者认为由于其他情况不能参与本临床试验的患者。

Exclusion criteria：

1) Previous ipsilateral forefoot surgery; 2) Previous history of venous thromboembolism; 3) Patients with contraindications to tranexamic acid as well as analgesic drugs such as flurbiprofen, aminophenol hydrocodone and tramadol; 4) Patients with severe hepatic or renal insufficiency, cardiovascular, cerebrovascular or other serious diseases; 5) patients with poorly controlled diabetes mellitus (glycated hemoglobin A1c > 8.0%) 6) Patients with osteoarthrosis and active infection of the first metatarsophalangeal joint; 7) Patients who need to combine other toe interphalangeal joints and metatarsophalangeal joints orthopedically at the same time during the operation; 8) Patients who are participating in other drug or medical device clinical trials and have not met their primary endpoints; 9) Patients who, in the opinion of the investigator, cannot participate in this clinical trial due to other circumstances.

研究实施时间：

Study execute time：

从 From 2023-11-20 00:00:00至 To 2025-10-20 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-12-20 00:00:00 至 To 2024-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

37

Group：

Test group

Sample size：

干预措施：

术中关闭切口前于截骨面喷洒1g氨甲环酸。

干预措施代码：

Intervention：

Intraoperatively, 1 g of tranexamic acid was sprayed on the osteotomy surface before closing the incision.

Intervention code：

组别：

对照组

样本量：

37

Group：

Control group

Sample size：

干预措施：

术中关闭切口前于截骨面喷洒1g生理盐水。

干预措施代码：

Intervention：

Intraoperatively, 1 g of saline was sprayed on the osteotomy surface before closing the incision.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 Beijing 

市(区县)：

  

Country：

China 

Province：

None Selected 

City：

 

单位(医院)：

首都医科大学附属北京积水潭医院 

单位级别：

三甲 

Institution
hospital：

Beijing Jishuitan Hospital, Capital Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

前足周径

指标类型：

主要指标

Outcome：

Forefoot circumference

Type：

Primary indicator

测量时间点：

术前、术后24h

测量方法：

足周径用卷尺绕第一、第五跖骨头边缘一周测得。于术前及术后24h内分别进行测量，所得数值相减即为足周径变化量

Measure time point of outcome：

Preoperative and 24h postoperative

Measure method：

The circumference of the forefoot was measured with a tape measure around the edge of the first and fifth metatarsal heads. Measurements were taken preoperatively and 24 h postoperatively, and the resulting values were subtracted to determine the change in circumferential forefoot diameter.

指标中文名：

视觉模拟疼痛评分（VAS评分）

指标类型：

次要指标

Outcome：

Visual Analogue Scale, VAS

Type：

Secondary indicator

测量时间点：

术前、术后24h、48h

测量方法：

在纸上画一条10cm的粗直线，一端为无疼痛，另 一端为难以忍受的剧烈疼痛，病人根据自己感受到的疼痛程度进行评分

Measure time point of outcome：

Pre-operative, 24h and 48h post-operative

Measure method：

Draw a 10-cm thick line on a piece of paper, with no pain at one end and severe intolerable pain at the other, and rate the pain according to how much pain the patient feels.

指标中文名：

第一跖骨头前后径

指标类型：

次要指标

Outcome：

Anteroposterior diameter of the first metatarsal head

Type：

Secondary indicator

测量时间点：

术前、术后24h

测量方法：

第一跖骨头前后径在第一跖骨头趾蹼处垂直于足底用游标卡尺测得。于术前及术后24h内分别进行测量，所得数值相减（术后-术前）即为第一跖骨头前后径变化量。

Measure time point of outcome：

Preoperative and 24h postoperative

Measure method：

The anteroposterior diameter of the first metatarsal head was measured at the toe web of the first metatarsal head perpendicular to the plantar surface of the foot using a vernier caliper. Measurements were taken preoperatively and 24 h postoperatively, and the resulting values were subtracted (postoperatively - preoperatively) to determine the amount of change in the anteroposterior diameter of the first metatarsal head.

指标中文名：

术后CT中测得第一跖骨中分线长度和足底垂线长度

指标类型：

次要指标

Outcome：

Length of the first metatarsal mid-division line and plantar plumb line measured on postoperative CT

Type：

Secondary indicator

测量时间点：

术后

测量方法：

Measure time point of outcome：

Post-operative

Measure method：

指标中文名：

术后足部肿胀评价表

指标类型：

次要指标

Outcome：

Postoperative Foot Swelling Evaluation Form

Type：

Secondary indicator

测量时间点：

出院前

测量方法：

共分为满意（5分）、比较满意（4分）、一般（3分）、比较不满意（2分）、不满意（0分），由患者出院前由患者自行打分

Measure time point of outcome：

Pre-hospitalization

Measure method：

A total of 5 points were categorized as satisfactory (5 points), relatively satisfactory (4 points), average (3 points), relatively unsatisfactory (2 points), and unsatisfactory (0 points), which were scored by the patients themselves before they were discharged from hospitals

指标中文名：

药物不良反应

指标类型：

副作用指标

Outcome：

Adverse drug reaction

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

爆发痛镇痛药物使用情况

指标类型：

次要指标

Outcome：

Use of analgesic drugs for eruptive pain

Type：

Secondary indicator

测量时间点：

用药即刻

测量方法：

记录镇痛药物第一次使用时间以及出院前镇痛药物用量

Measure time point of outcome：

Time of application

Measure method：

Record the time of first use of analgesic medication and the amount of analgesic medication used prior to discharge from the hospital

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 70 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

纳入的患者由主要研究者采用随机数方式进行分组，进入试验组或对照组，获得随机号：××。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Included patients were grouped by the principal investigator using a random number into either the trial or control group, obtaining a randomization number: xxx.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

受试者：签署知情同意书，术前不知道自己被分到试验组or对照组，术中看不到手术操作，不知道在关闭切口前在截骨面喷洒的是1g氨甲环酸还是1g生理盐水。 术者：负责术前使用随机数方式分组，同时负责术中喷洒氨甲环酸or生理盐水。由于手术治疗的特殊性，难以对术者设盲。 研究者：主要负责术前术后相关数据的测量、统计分析。对研究者设盲，研究者在测量数据以及统计分析的时候不知道该患者是否使用氨甲环酸，可减少个人意愿所导致的研究偏斜。

Blinding：

Subjects: signed informed consent, did not know preoperatively whether they were assigned to the experimental or control group, did not see the surgical operation intraoperatively, and did not know whether 1 g of tranexamic acid or 1 g of saline was sprayed on the osteotomized surface before closing the incision. Operator: responsible for preoperative grouping using random numbers and also responsible for intraoperative spraying of tranexamic acid OR saline. Due to the specific nature of the surgical treatment, it is difficult to blind the operator. The researcher: mainly responsible for the measurement and statistical analysis of preoperative and postoperative data. By blinding the researcher, the researcher does not know whether the patient is using tranexamic acid or not when measuring the data as well as statistically analyzing it, which can reduce the study skewing caused by personal will.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-12-20 16:38:08