中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR1900022493
最近更新日期： Date of Last Refreshed on：	2019-04-13 21:27:44
注册时间： Date of Registration：	2019-04-13 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	A new method for diagnosis of anterior cruciate ligament tear: MRI with maximum flexion of knee in the prone position
Public title：	A new method for diagnosis of anterior cruciate ligament tear: MRI with maximum flexion of knee in the prone position
注册题目简写：
English Acronym：	a new MRI position ACL tear diagnosis
研究课题的正式科学名称：	A new method for diagnosis of anterior cruciate ligament tear: MRI with maximum flexion of knee in the prone position
Scientific title：	A new method for diagnosis of anterior cruciate ligament tear: MRI with maximum flexion of knee in the prone position
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：	cagatay tekin	研究负责人：	burak gunaydin
Applicant：	cagatay tekin	Study leader：	burak gunaydin
申请注册联系人电话： Applicant telephone：	+90 55 56164634	研究负责人电话： Study leader's telephone：	+90 50 57887965
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：	cagat87@gmail.com	研究负责人电子邮件： Study leader's E-mail：	docburak@gmail.com
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：	Sirnak state, Turkey	研究负责人通讯地址：	Namik Kemal Mah. Kampüs Cad. No:1, Merkez, Tekirdag, 59030 Tekirdag, Turkey
Applicant address：	Sirnak state, Turkey	Study leader's address：	Namik Kemal Mah. Kampüs Cad. No:1, Merkez, Tekirdag, 59030 Tekirdag, Turkey
申请注册联系人邮政编码： Applicant postcode：	73000	研究负责人邮政编码： Study leader's postcode：	59030
申请人所在单位：	土尔其锡尔纳克州立医院
Applicant's institution：	Sirnak state hospital
研究负责人所在单位：	泰基尔达.纳米克.凯末尔大学
Affiliation of the Leader：	tekirdag namik kemal university

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2018/83/06/04	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：	凯末尔大学医学院非侵入性临床研究伦理委员会
Name of the ethic committee：	NAMIK KEMAL University faculty of medicine Non-Invasive Clinical Research Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2018-09-06 00:00:00
伦理委员会联系人：	engin deniz rencber
Contact Name of the ethic committee：	engin deniz rencber
伦理委员会联系地址：	NKü GiR?S?MSEL OLMAYAN ARASTIRMALAR ETiK KuRULU//NAMIK KEMAL University faculty of medicine Non-Invasive Clinical Research Ethics Committee
Contact Address of the ethic committee：	NKü GiR?S?MSEL OLMAYAN ARASTIRMALAR ETiK KuRULU//NAMIK KEMAL University faculty of medicine Non-Invasive Clinical Research Ethics Committee
伦理委员会联系人电话： Contact phone of the ethic committee：	+90 28 22505904	伦理委员会联系人邮箱： Contact email of the ethic committee：	edrencber@nku.edu.tr

研究实施负责（组长）单位：

土尔其锡尔纳克州立医院

Primary sponsor：

Sirnak state hospital

研究实施负责（组长）单位地址：

土尔其锡尔纳克州立医院

Primary sponsor's address：

Sirnak state hospital

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	土尔其	省(直辖市)：	Tekirdag	市(区县)：
Country：	Turkey	Province：	tekirdag	City：	suleymanpasa
单位(医院)：	namik kemal health application & research center	具体地址：	namik kemal mah NKU saglik arastirma ve uygUlama merkezi
Institution hospital：	namik kemal health application & research center	Address：	namik kemal mah NKU saglik arastirma ve uygUlama merkezi

经费或物资来源：

No

Source(s) of funding：

no

研究疾病：

Anterior cruciate ligament rupture

Target disease：

Anterior cruciate ligament rupture

研究疾病代码：

s83.5

Target disease code：

s83.5

研究类型：

诊断试验

Study type：

Diagnostic test

研究所处阶段：

I期临床试验

Study phase：

1

研究设计：

病例对照研究

Study design：

Case-Control study

研究目的：

In this study, it was aimed to compare the patients who have suspicious partial ACL tear and were suggested to arthroscopic surgery due to additional intra-articular lesion according to MRI findings of the knee in supine position at the full extension of knee, of MRI findings at maximum flexion of the knee in the prone position with the ACL findings determined in the arthroscopic surgery. Besides; in order to research the efficacy of MRI with the knee at maximum flexion in the prone position in determining the partial tear of ACL which is evaluated as suspicious. Due to the hypothesis of the study, it was envisaged to obtain a more accurate finding of the partial ACL tear and MRI in the prone position with maximum flexion of the knee.

Objectives of Study：

In this study, it was aimed to compare the patients who have suspicious partial ACL tear and were suggested to arthroscopic surgery due to additional intra-articular lesion according to MRI findings of the knee in supine position at the full extension of knee, of MRI findings at maximum flexion of the knee in the prone position with the ACL findings determined in the arthroscopic surgery. Besides; in order to research the efficacy of MRI with the knee at maximum flexion in the prone position in determining the partial tear of ACL which is evaluated as suspicious. Due to the hypothesis of the study, it was envisaged to obtain a more accurate finding of the partial ACL tear and MRI in the prone position with maximum flexion of the knee.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

The patients, who had no additional pathology (meniscus tears, cartilage injury) despite having a suspicion of a partial tear determined in the MRI in the normal position, these patients were excluded from the study without any further investigation. In addition, patients who had previously undergone arthroscopic or open knee surgery and had multiple ligament damages, patients with inflammatory arthritis, patients with MRI in the inappropriate position were not included in the study.

Exclusion criteria：

The patients, who had no additional pathology (meniscus tears, cartilage injury) despite having a suspicion of a partial tear determined in the MRI in the normal position, these patients were excluded from the study without any further investigation. In addition, patients who had previously undergone arthroscopic or open knee surgery and had multiple ligament damages, patients with inflammatory arthritis, patients with MRI in the inappropriate position were not included in the study.

研究实施时间：

Study execute time：

从 From 2018-02-03 00:00:00至 To 2018-09-13 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2017-01-13 00:00:00 至 To 2018-08-13 00:00:00

诊断试验：

Diagnostic Tests：

金标准或参考标准（即可准确诊断某疾病的单项方法或多项联合方法，在本研究中用于诊断是否有该病的临床参考标准）：	关节镜手术
Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):	arthroscopic surgery findings
指标试验（即本研究的待评估诊断试验，无论为方法、生物标志物或设备，均请列出名称）：	full extension MRI
Index test:	full extension MRI
目标人群（可以是某种疾病患者或正常人群，详细描述其疾病特征，注意应纳入符合分布特点的全序列病例，具有良好的代表性）	Patients with partial ACL tear who planned arthroscopic surgery were informed about the treatment with meniscal and cartilage lesions and arthroscopic ACL evaluation ; patients with total tear or partial tear with more than 50% of ACL bundles torn were informed about ACL reconstruction to be made; patients	例数: Sample size: 45
Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):	Patients with partial ACL tear who planned arthroscopic surgery were informed about the treatment with meniscal and cartilage lesions and arthroscopic ACL evaluation ; patients with total tear or partial tear with more than 50% of ACL bundles torn were informed about ACL reconstruction to be made; patients
容易混淆的疾病人群（即与目标疾病不易区分的一种或多种不同疾病，应避免采用正常人群对照的病例-对照设计）：	MRI examination was performed to these patients in the prone position while the knee was in maximum flexion (110°–140°). Performing MRI with the knee at flexion facilitates understanding of the ACL pathology [14–16]. In order to have an MRI on a patient’s knee, the patient must lie in prone or supin	例数: Sample size: 22
Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:	MRI examination was performed to these patients in the prone position while the knee was in maximum flexion (110°–140°). Performing MRI with the knee at flexion facilitates understanding of the ACL pathology [14–16]. In order to have an MRI on a patient’s knee, the patient must lie in prone or supin

研究实施地点：

Countries of recruitment and research settings：

国家：	土尔其	省(直辖市)：	泰基达格	市(区县)：	suleymanpasa
Country：	Turkey	Province：	tekirdag	City：	suleymanpasa
单位(医院)：	namik kemal health and application center	单位级别：	三级医院
Institution hospital：	namik kemal health and application center	Level of the institution：	Tertiary Hospital

测量指标：

Outcomes：

指标中文名：	efficiency of flexion MRI of knee	指标类型：	附加指标
Outcome：	efficiency of flexion MRI of knee	Type：	Additional indicator
测量时间点：	18 months	测量方法：	MRI
Measure time point of outcome：	18 months	Measure method：	MRI

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：		组织：
Sample Name：	diagnostic test	Tissue：	knee
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：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	39	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）：

N/A

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

N/A

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：	N/A
Blinding：	N/A
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	否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）：	we will publish an issue international journal of surgery at following months
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	we will publish an issue international journal of surgery at following months
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：	CASE REPORT FORMS COULD NOT SHAR?NG BEFORE PUBLICATION BUT CRF COMPLETION GUIDELINES (CGG) AS WRITTEN BELOW Twenty-one of the 22 patients included in the study were male and 1 patient was female. The mean age of the patients was 28.5 (18–39). While 12 patients complained about the right knee, 10 patients complained about the left knee. The mean angle of knee flexion during MRI was found to be 122.5 ° (range: 104–144). In the MRI images of these patients with the maximum flexion of the knee in the prone position, it was found that 12 (54.5%) patients had an intact ACL, 5 (22.7%) patients had a partial tear and 5 (22.7%) patients had a total tear (Table 1). Arthroscopic surgery applied to the patient was performed by a single surgeon. In the arthroscopic operation of 22 patients, it was found that 10 (45.4%) patients had an intact ACL, 7 (31.8%) patients had a partial tear and 5 (22.7%) patients had a total tear (Table 1). AM bundle was torn, PL bundle was intact at the all patients with partial tears. Arthroscopic ACL reconstruction with anatomic single-band method was performed in 12 patients with a partial and total tear. 20 patients had a tear in their meniscus; 10 patients underwent partial meniscectomy and 10 patients underwent meniscus repair. Of these patients diagnosed with the meniscus tears, 4 patients' meniscal tears were found in the lateral meniscus and 3 patients underwent partial meniscectomy and 1 patient underwent meniscus repair. Of the 16 patients with a tear in the medial meniscus, 9 patients underwent meniscus repair and 7 patients underwent partial meniscectomy. Chondral damage was detected in 4 patients who treated with microfracture. Considering the chondral damages of these patients, 2 patients had it in medial femoral condyle and the others had it in lateral femoral condyle (Table 2). Compared the findings of ACL during surgery and MRI findings in the prone position with maximum flexion in the knee with the MRI findings in supine position with the knee in neutral position, they were observed to be more compatible (respectively, ICC values 0.874 [0.696–0.948] and 0.000 [-1.409–0.585]). It was revealed that the sensitivity of MRI at maximum knee flexion in the prone position was 83%, its specificity was 100%, positive predictive value was 100%, and the negative predictive value was 83%.
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CASE REPORT FORMS COULD NOT SHAR?NG BEFORE PUBLICATION BUT CRF COMPLETION GUIDELINES (CGG) AS WRITTEN BELOW Twenty-one of the 22 patients included in the study were male and 1 patient was female. The mean age of the patients was 28.5 (18–39). While 12 patients complained about the right knee, 10 patients complained about the left knee. The mean angle of knee flexion during MRI was found to be 122.5 ° (range: 104–144). In the MRI images of these patients with the maximum flexion of the knee in the prone position, it was found that 12 (54.5%) patients had an intact ACL, 5 (22.7%) patients had a partial tear and 5 (22.7%) patients had a total tear (Table 1). Arthroscopic surgery applied to the patient was performed by a single surgeon. In the arthroscopic operation of 22 patients, it was found that 10 (45.4%) patients had an intact ACL, 7 (31.8%) patients had a partial tear and 5 (22.7%) patients had a total tear (Table 1). AM bundle was torn, PL bundle was intact at the all patients with partial tears. Arthroscopic ACL reconstruction with anatomic single-band method was performed in 12 patients with a partial and total tear. 20 patients had a tear in their meniscus; 10 patients underwent partial meniscectomy and 10 patients underwent meniscus repair. Of these patients diagnosed with the meniscus tears, 4 patients' meniscal tears were found in the lateral meniscus and 3 patients underwent partial meniscectomy and 1 patient underwent meniscus repair. Of the 16 patients with a tear in the medial meniscus, 9 patients underwent meniscus repair and 7 patients underwent partial meniscectomy. Chondral damage was detected in 4 patients who treated with microfracture. Considering the chondral damages of these patients, 2 patients had it in medial femoral condyle and the others had it in lateral femoral condyle (Table 2). Compared the findings of ACL during surgery and MRI findings in the prone position with maximum flexion in the knee with the MRI findings in supine position with the knee in neutral position, they were observed to be more compatible (respectively, ICC values 0.874 [0.696–0.948] and 0.000 [-1.409–0.585]). It was revealed that the sensitivity of MRI at maximum knee flexion in the prone position was 83%, its specificity was 100%, positive predictive value was 100%, and the negative predictive value was 83%.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2019-04-13 21:27:44