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Does the anterolateral ligament status have an effect on the preference of anterior cruciate ligament reconstruction in the patients with partial anterior cruciate ligament tears?
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注册号:

Registration number:

ChiCTR2000028788 

最近更新日期:

Date of Last Refreshed on:

2020-01-04 

注册时间:

Date of Registration:

2020-01-04 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

Does the anterolateral ligament status have an effect on the preference of anterior cruciate ligament reconstruction in the patients with partial anterior cruciate ligament tears? 

Public title:

Does the anterolateral ligament status have an effect on the preference of anterior cruciate ligament reconstruction in the patients with partial anterior cruciate ligament tears? 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Does the anterolateral ligament status have an effect on the preference of anterior cruciate ligament reconstruction in the patients with partial anterior cruciate ligament tears? 

Scientific title:

Does the anterolateral ligament status have an effect on the preference of anterior cruciate ligament reconstruction in the patients with partial anterior cruciate ligament tears? 

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 günaydin 

Applicant:

cagatay tekin 

Study leader:

burak günaydin 

申请注册联系人电话:

Applicant telephone:

+905556164634 

研究负责人电话:

Study leader's telephone:

+905957887965 

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:

Cizre state hospital, Sirnak state, Turkey 

研究负责人通讯地址:

Namk Kemal, Namik Kemal Mahallesi Kampüs Caddesi, Turkey 

Applicant address:

Cizre state hospital, Sirnak state, Turkey 

Study leader's address:

Namk Kemal, Namik Kemal Mahallesi Kampüs Caddesi, Turkey 

申请注册联系人邮政编码:

Applicant postcode:

73200 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

土耳其锡尔纳克州立医院 

Applicant's institution:

Cizre state hospital, Sirnak state, Turkey 

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:

2019.132.08.04 

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:

GiriSimsel Olmayan Klinik AraStirmalar Etik Kurulu 

Name of the ethic committee:

GiriSimsel Olmayan Klinik AraStirmalar Etik Kurulu 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-01 

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:

NKU GiRiSiMSEL OLMAYAN ARASTIRMALAR ETiK KuRULU//NAMIK KEMAL University faculty of medicine Non-Invasive Clinical Research Ethics Committee 

Contact Address of the ethic committee:

NKU GiRiSiMSEL 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:

namik kemal health application & research center 

Primary sponsor:

namik kemal health application & research center 

研究实施负责(组长)单位地址:

namik kemal mah NKU saglik arastirma ve uygUlama merkezi 

Primary sponsor's address:

namik kemal mah NKU saglik arastirma ve uygUlama merkezi 

试验主办单位(项目批准或申办者):

Secondary sponsor:

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:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

ACL tears are divided into two as total and partial. There is no consensus on the criteria for the diagnosis of a partial ACL tear [1]. Although partial tears are defined as one of the anteromedial (AM) and posterolateral (PL) bundles being intact and the other being ruptured, they are also defined as the continuity of some of the tendons between the femoral and tibial attachment of the ACL [2]. Among all ACL tears, the rate of partial ACL tears was found as 10-35% [3]. The continuation of rotational instability in some patients after ACL reconstruction suggested that additional support structures are effective in stability. In later studies, it was shown that the anterolateral ligament (ALL) also contributes to stability together with the ACL of the knee [3-7]. The study aimed to retrospectively determine the effect of ALL status, whether intact or ruptured, on the choice of treatment in patients with partial ACL tears. 

Objectives of Study:

ACL tears are divided into two as total and partial. There is no consensus on the criteria for the diagnosis of a partial ACL tear [1]. Although partial tears are defined as one of the anteromedial (AM) and posterolateral (PL) bundles being intact and the other being ruptured, they are also defined as the continuity of some of the tendons between the femoral and tibial attachment of the ACL [2]. Among all ACL tears, the rate of partial ACL tears was found as 10-35% [3]. The continuation of rotational instability in some patients after ACL reconstruction suggested that additional support structures are effective in stability. In later studies, it was shown that the anterolateral ligament (ALL) also contributes to stability together with the ACL of the knee [3-7]. The study aimed to retrospectively determine the effect of ALL status, whether intact or ruptured, on the choice of treatment in patients with partial ACL tears. 

药物成份或治疗方案详述:

ACL tears are divided into two as total and partial. There is no consensus on the criteria for the diagnosis of a partial ACL tear [1]. Although partial tears are defined as one of the anteromedial (AM) and posterolateral (PL) bundles being intact and the other being ruptured, they are also defined as the continuity of some of the tendons between the femoral and tibial attachment of the ACL [2]. Among all ACL tears, the rate of partial ACL tears was found as 10-35% [3]. The continuation of rotational instability in some patients after ACL reconstruction suggested that additional support structures are effective in stability. In later studies, it was shown that the anterolateral ligament (ALL) also contributes to stability together with the ACL of the knee [3-7]. The study aimed to retrospectively determine the effect of ALL status, whether intact or ruptured, on the choice of treatment in patients with partial ACL tears. 

Description for medicine or protocol of treatment in detail:

ACL tears are divided into two as total and partial. There is no consensus on the criteria for the diagnosis of a partial ACL tear [1]. Although partial tears are defined as one of the anteromedial (AM) and posterolateral (PL) bundles being intact and the other being ruptured, they are also defined as the continuity of some of the tendons between the femoral and tibial attachment of the ACL [2]. Among all ACL tears, the rate of partial ACL tears was found as 10-35% [3]. The continuation of rotational instability in some patients after ACL reconstruction suggested that additional support structures are effective in stability. In later studies, it was shown that the anterolateral ligament (ALL) also contributes to stability together with the ACL of the knee [3-7]. The study aimed to retrospectively determine the effect of ALL status, whether intact or ruptured, on the choice of treatment in patients with partial ACL tears. 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

Following the orthopedic examinations and magnetic resonance imaging (MRI) performed between 2016 and 2018, a total of 120 patients with suspected partial ACL tears and with meniscal and cartilage lesions requiring arthroscopic knee surgery were identified. After examining the ALLs of these patients using MRI, 60 patients who were diagnosable and had sufficient follow-up were included in the study retrospectively.  

Inclusion criteria

Following the orthopedic examinations and magnetic resonance imaging (MRI) performed between 2016 and 2018, a total of 120 patients with suspected partial ACL tears and with meniscal and cartilage lesions requiring arthroscopic knee surgery were identified. After examining the ALLs of these patients using MRI, 60 patients who were diagnosable and had sufficient follow-up were included in the study retrospectively.  

排除标准:

The patients who are not diagnosable for ALL status using MRI, with total ACL tears in MRI, and at the same time with physical examination findings suggestive of total ACL tears were excluded from the study. Patients with a follow-up of less than one year were excluded from the study. 

Exclusion criteria:

The patients who are not diagnosable for ALL status using MRI, with total ACL tears in MRI, and at the same time with physical examination findings suggestive of total ACL tears were excluded from the study. Patients with a follow-up of less than one year were excluded from the study. 

研究实施时间:

Study execute time:

From2016-12-24To 2019-10-31 

干预措施:

Interventions:

组别:

underwent ACL reconstruction

样本量:

32

Group:

underwent ACL reconstruction

Sample size:

干预措施:

PERFORMED

干预措施代码:

Intervention:

PERFORMED

Intervention code:

组别:

NOT underwent ACL reconstruction

样本量:

28

Group:

NOT underwent ACL reconstruction

Sample size:

干预措施:

NOT PERFORMED

干预措施代码:

Intervention:

NOT PERFORMED

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

土耳其 

省(直辖市):

TEKIRDAG 

市(区县):

SULEYMANPASA 

Country:

TURKEY 

Province:

TEKIRDAG 

City:

SULEYMANPASA 

单位(医院):

namik kemal health application & research center 

单位级别:

三级 

Institution
hospital:

namik kemal health application & research center  

Level of the institution:

TERTIARY 

测量指标:

Outcomes:

指标中文名:

effect of ALL in partial ACL Tears

指标类型:

次要指标 

Outcome:

effect of ALL in partial ACL Tears

Type:

Secondary indicator 

测量时间点:

24

测量方法:

Measure time point of outcome:

24

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 39 years

性别:

男性

Gender:

Male

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

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 ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

Real time access

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 SHARING BEFORE PUBLICATION BUT CRF COMPLETION GUIDELINES (CGG) AS WRITTEN BELOW Sixty patients with partial ACL tears were divided into two groups according to whether ACL reconstruction was performed; 32 patients underwent ACL reconstruction and were determined as group 1, and 28 patients did not undergo ACL reconstruction and were considered as group 2. Among the 60 patients with partial ACL tears, it was identified by the radiologist that the ALLs of 36 patients were ruptured and 24 patients’ ALLs were intact. It was found that the ALLs of 18 patients in group 1 were ruptured, whereas 14 patients’ ALLs in this group were intact. The ALL of six patients in group 2 were ruptured, and 22 patients’ ALLs in group 2 were intact (Table 1). Among the patients in group 1, ACL reconstruction was performed to the right knee of 18 patients and to the left knee of 14 patients. Among the patients in group 2, 15 patients had symptoms in the right knee, and 13 patients had symptoms in the left knee. There were four female patients in group 1 and two in group 2. The mean age of patients in group 1 was 29.19 (range, 18-39) years, and was 30.93 (range, 17-38) years in group 2. The length of follow-up of the patients in group 1 and group 2 was 22.88 months and 21.68 months (range, 12-35 months), respectively. The average age of the two groups (p=0.36) and follow-up period of two group were not evaluated to be statistically significant (p=0.48) (Table 2). As a result of the arthroscopic knee surgery performed to the 60 patients with partial ACL tears, the meniscus tears was found in 56 patients. A tear was identified in the medial meniscus of 36 patients and in the lateral meniscus of 20 patients. Meniscus repair was performed to 40 of these 56 patients, and 16 patients had partial meniscectomy. Chondral lesions were identified in 10 patients and microfractures were performed. The chondral injuries of these patients were to the medial femoral condyle in 5 patients and the lateral femoral condyle in 5 patients (Table 3). It was observed that the identification of ALL rupture was more concordant by administering ACL reconstruction surgery in patients with partial ACL tears (p=0.006). As a result of the ALL status, when it was compared whether a reconstruction was performed to patients with partial ACL tears, ALL rupture and ACL reconstruction were well correlated (ICC values 0.355 [0.113-0.557] and 0.523 [0.202-0.715], respectively). When the relation between the performance of reconstruction to patients with partial ACL tears and ALL rupture was examined, it was found the sensitivity and specificity were 75% and 61.1%, and the positive and negative predictive values were 56.25% and 78.57%, respectively. Seventy-five percent of the patients with partial ACL tears who had ruptured ALLs in MRI underwent ACL reconstruction. Six (21.5%) patients had a partial ACL tear and ruptured ALL in MRI but did not undergo ACL reconstruction.

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

CASE REPORT FORMS COULD NOT SHARING BEFORE PUBLICATION BUT CRF COMPLETION GUIDELINES (CGG) AS WRITTEN BELOW Sixty patients with partial ACL tears were divided into two groups according to whether ACL reconstruction was performed; 32 patients underwent ACL reconstruction and were determined as group 1, and 28 patients did not undergo ACL reconstruction and were considered as group 2. Among the 60 patients with partial ACL tears, it was identified by the radiologist that the ALLs of 36 patients were ruptured and 24 patients’ ALLs were intact. It was found that the ALLs of 18 patients in group 1 were ruptured, whereas 14 patients’ ALLs in this group were intact. The ALL of six patients in group 2 were ruptured, and 22 patients’ ALLs in group 2 were intact (Table 1). Among the patients in group 1, ACL reconstruction was performed to the right knee of 18 patients and to the left knee of 14 patients. Among the patients in group 2, 15 patients had symptoms in the right knee, and 13 patients had symptoms in the left knee. There were four female patients in group 1 and two in group 2. The mean age of patients in group 1 was 29.19 (range, 18-39) years, and was 30.93 (range, 17-38) years in group 2. The length of follow-up of the patients in group 1 and group 2 was 22.88 months and 21.68 months (range, 12-35 months), respectively. The average age of the two groups (p=0.36) and follow-up period of two group were not evaluated to be statistically significant (p=0.48) (Table 2). As a result of the arthroscopic knee surgery performed to the 60 patients with partial ACL tears, the meniscus tears was found in 56 patients. A tear was identified in the medial meniscus of 36 patients and in the lateral meniscus of 20 patients. Meniscus repair was performed to 40 of these 56 patients, and 16 patients had partial meniscectomy. Chondral lesions were identified in 10 patients and microfractures were performed. The chondral injuries of these patients were to the medial femoral condyle in 5 patients and the lateral femoral condyle in 5 patients (Table 3). It was observed that the identification of ALL rupture was more concordant by administering ACL reconstruction surgery in patients with partial ACL tears (p=0.006). As a result of the ALL status, when it was compared whether a reconstruction was performed to patients with partial ACL tears, ALL rupture and ACL reconstruction were well correlated (ICC values 0.355 [0.113-0.557] and 0.523 [0.202-0.715], respectively). When the relation between the performance of reconstruction to patients with partial ACL tears and ALL rupture was examined, it was found the sensitivity and specificity were 75% and 61.1%, and the positive and negative predictive values were 56.25% and 78.57%, respectively. Seventy-five percent of the patients with partial ACL tears who had ruptured ALLs in MRI underwent ACL reconstruction. Six (21.5%) patients had a partial ACL tear and ruptured ALL in MRI but did not undergo ACL reconstruction.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-01-04
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