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注册号： Registration number：	ChiCTR2000028727
最近更新日期： Date of Last Refreshed on：	2020-01-01 20:18:32
注册时间： Date of Registration：	2020-01-01 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	Is cyclic exercise performed effective on grafts during ACL reconstruction?
Public title：	Is cyclic exercise performed effective on grafts during ACL reconstruction?
注册题目简写：
English Acronym：
研究课题的正式科学名称：	Is cyclic exercise performed effective on grafts during ACL reconstruction?
Scientific title：	Is cyclic exercise performed effective on grafts during ACL reconstruction?
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：	+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)：	https://cizredh.saglik.gov.tr	研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：	http://tip.nku.edu.tr/Ortopedi%20ve%20Travmatoloji%20ABD
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：	Namik Kemal Mah. Kampüs Cad. No:1, Merkez, Tekirdag, 59030 Tekirdag, Turkey
Applicant address：	Cizre state hospital, 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：	73200	研究负责人邮政编码： Study leader's postcode：	59030
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
研究负责人所在单位：	土耳其锡尔纳克州立医院
Affiliation of the Leader：	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：	2018.151.11.01	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：	2018-12-27 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：	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：

国家：	土耳其	省(直辖市)：	TEK?RDAG	市(区县)：	SULEYMANPASA
Country：	Turkey	Province：	TEK?RDAG	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：

无

Source(s) of funding：

no

研究疾病：

前交叉韧带断裂

Target disease：

Anterior cruciate ligament rupture

研究疾病代码：

s83.5

Target disease code：

s83.5

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

I期临床试验

Study phase：

1

研究设计：

非随机对照试验

Study design：

Non randomized control

研究目的：

Patients who underwent ligament reconstruction were retrospectively evaluated and the aim of this study was to investigate the effect of exercise and cyclic exercise on the results of physical examination, knee joint stability tests, and functional evaluation tests.

Objectives of Study：

Patients who underwent ligament reconstruction were retrospectively evaluated and the aim of this study was to investigate the effect of exercise and cyclic exercise on the results of physical examination, knee joint stability tests, and functional evaluation tests.

药物成份或治疗方案详述：

The most ideal treatment option for anterior cruciate ligament reconstruction is the subject of debate with regard to the ideal time of surgery [6]. New methods have been attempted in the reconstruction of the ACL. During both ACL reconstruction and single- and double-bundle reconstruction, grafts are fixed to the femoral tunnel, and maximum flexion and full extension movements are repeated 20 times before the tibial fixation and the grafts are stretched [7,8]. This movement is called cyclic exercise. This exercise has two purposes; the first is to stretch the graft to a certain extent, and the second is to ensure that the graft is fully inserted into the femoral tunnel. In the study, the graft was removed from the tibial tunnel through the endobutton of the graft in patients in group 1 after the graft was removed from the tibial tunnel, and the maximum flexion and full extension movement was repeated 20 times. In group 2, after the femoral fixation with endobutton, the graft was removed and stretched through the tibial tunnel but no string flexion and extension movements were performed.

Description for medicine or protocol of treatment in detail：

The most ideal treatment option for anterior cruciate ligament reconstruction is the subject of debate with regard to the ideal time of surgery [6]. New methods have been attempted in the reconstruction of the ACL. During both ACL reconstruction and single- and double-bundle reconstruction, grafts are fixed to the femoral tunnel, and maximum flexion and full extension movements are repeated 20 times before the tibial fixation and the grafts are stretched [7,8]. This movement is called cyclic exercise. This exercise has two purposes; the first is to stretch the graft to a certain extent, and the second is to ensure that the graft is fully inserted into the femoral tunnel. In the study, the graft was removed from the tibial tunnel through the endobutton of the graft in patients in group 1 after the graft was removed from the tibial tunnel, and the maximum flexion and full extension movement was repeated 20 times. In group 2, after the femoral fixation with endobutton, the graft was removed and stretched through the tibial tunnel but no string flexion and extension movements were performed.

纳入标准：

Inclusion criteria

排除标准：

Patients with less than 8 months of follow-up, those with other lesions concomitant with ACL lesions, those aged younger than 16 years, patients with arthrosis, ACL ruptures in both knees (with or without treatment from the other knee), meniscus and cartilage lesions in the other knee (treated), and those who could not perform the single-legged hop test in the current evaluation were excluded.

Exclusion criteria：

Patients with less than 8 months of follow-up, those with other lesions concomitant with ACL lesions, those aged younger than 16 years, patients with arthrosis, ACL ruptures in both knees (with or without treatment from the other knee), meniscus and cartilage lesions in the other knee (treated), and those who could not perform the single-legged hop test in the current evaluation were excluded.

研究实施时间：

Study execute time：

从 From 2016-03-01 00:00:00至 To 2018-05-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2016-03-01 00:00:00 至 To 2018-05-21 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	30
Group：	Experimental group	Sample size：	30
干预措施：	PERFORMED CYCLiC EXERcise	干预措施代码：	S83.5
Intervention：	PERFORMED CYCLiC EXERcise	Intervention code：	S83.5

组别：	对照组	样本量：	29
Group：	control group	Sample size：	29
干预措施：	not performed cyclic exercise	干预措施代码：	s83.5
Intervention：	not performed cyclic exercise	Intervention code：	s83.5

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 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 cyclic exercise	指标类型：	主要指标
Outcome：	efficiency of cyclic exercise	Type：	Primary indicator
测量时间点：	15	测量方法：	measurement by examinational tests
Measure time point of outcome：	15	Measure method：	measurement by examinational tests

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	graft	组织：	hamstring tendons
Sample Name：	graft	Tissue：	hamstring tendons
人体标本去向	使用后保存	说明
Fate of sample：	Preservation 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	36	岁 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）：

No

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

all patients who have appropriate follow up were included thus no randomization procedure was performed

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：	No
Blinding：	No
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 The mean age of patients in groups 1 and 2 were 26.2 (range, 18-36) years and 25.5 (range, 18-35) years in group 2 in. The mean follow-up period was 14.6 (range, 8-22) months in group 1 and 13.9 (range, 8-21) months in group 2 (Table 1). The mean age (p=0.59) and duration of follow-up (p=0.45) were not statistically significantly different between the groups. Twenty-nine patients (96.6%) in group 1 were male. Fifteen (50%) of these patients underwent ligament reconstruction in the left knee and 15 (50%) in the right knee. In group 2, 26 (89.6%) patients were male. Fifteen (51.7%) of these patients underwent surgery on the right knee and 14 (48.2%) had surgery on the left knee. The distribution of sex (p=0.58) and sides (p=0.89) was not statistically significantly different between the groups. The mean Lysholm activity score of group 1 was 95.1 ± 4.73 (range, 83-100), and 87 ± 7.4 (range, 78-100) of the group 2. The mean Lysholm activity score of patients who had cyclic exercise was higher. The mean Lysholm activity scores of patients who had cyclic exercise were statistically significantly higher than those of patients who did not undergo cyclic exercise (p<0.01) (Fig. 1). The modified Cincinnati scores of patients in groups 1 and 2 were 28.7 ± 1.44 (range, 24-30) and 26.1 ± 3.27 (range, 21-30). The great majority (96.6%, n=29) of patients in group 1 were found to be in the excellent level compared with 58.6% (n=16) of patients in group 2. The modified Cincinnati scores of patients who had cyclic exercise were statistically significantly higher than those of patients who did not undergo cyclic exercise (p<0.01) (Figure 2). The mean IKDC subjective knee assessment score was 91.9 (range, 83-100) in group 1 and 86.7 (range, 75-100) in group 2. In group 1, it was found that 46.6% (n=14) of patients were excellent, and 50% (n=15) were good, whereas 20.6% (n=6) of group 2 were excellent, and 65.5% (n=15) had good results. The mean IKDC subjective knee assessment scores of patients who underwent cyclic exercise were statistically significantly higher than those of patients who did not undergo cyclic exercise (p<0.01) (Figure 3). According to the IKDC score, 70% (n=21) had normal and 30% (n=9) had near-normal results in Group 1 patients and 56.8% (n=17) had normal and 41.4% (n=12) had near-normal results in Group 2 patients. All patients in both groups who had IKDC scoring during the last follow-up were included in A and B scores (Table 2). There was no statistically significant difference in IKDC scores between the groups (p=0.36). Although there was no statistically significant difference between the two-time IKDC activity scale ratios in the pre-injury period (p=0.43), the activity of patients in group 1 was better than in those in group 2 in the post-treatment period (p=0.04) (Figure 4). The mean degree of flexion was 136.6° (range, 120-160°) in patients in group 1. In group 2, it was 134.4° (120-150°) (p=0.43). Passive Lachman and anterior drawer tests were applied to the patients during their final follow-ups. The results were evaluated as 0-2 mm: (-), 3-5 mm: (+), 6-10 mm: (++), and 11-15 mm (+++) as recommended by the American Medical Association (Table 3-4). Anterior-drawer test and Lachman test (+++) of one patient undergoing Group 1, and three patients in group 2. The results of the ACL stability tests were not statistically significantly different the groups (p>0.05). In the evaluation of thigh atrophy, 15 cm proximal of the upper limit of the patella was measured by comparing the two thigh circles and divided into three degrees according to the determined length differences. The difference between the mean thigh diameters was 1.56 ± 0.91 cm in group 1 and 2.51 ± 1.13 cm in group 2 (Figure 5). The results of thigh atrophy were found to be statistically significantly different between the groups (p<0.01). The patients were asked to jump as far as they could on a single leg, and the test results of the operated and non-operated sides were compared after three repeated tests for both knees. In group 1, 23 patients were detected on 85% and in group 2, 17 patients were found below 85% (Figure 6). The results of the single-leg jump tests were statistically significantly different between the groups (p<0.01).
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 The mean age of patients in groups 1 and 2 were 26.2 (range, 18-36) years and 25.5 (range, 18-35) years in group 2 in. The mean follow-up period was 14.6 (range, 8-22) months in group 1 and 13.9 (range, 8-21) months in group 2 (Table 1). The mean age (p=0.59) and duration of follow-up (p=0.45) were not statistically significantly different between the groups. Twenty-nine patients (96.6%) in group 1 were male. Fifteen (50%) of these patients underwent ligament reconstruction in the left knee and 15 (50%) in the right knee. In group 2, 26 (89.6%) patients were male. Fifteen (51.7%) of these patients underwent surgery on the right knee and 14 (48.2%) had surgery on the left knee. The distribution of sex (p=0.58) and sides (p=0.89) was not statistically significantly different between the groups. The mean Lysholm activity score of group 1 was 95.1 ± 4.73 (range, 83-100), and 87 ± 7.4 (range, 78-100) of the group 2. The mean Lysholm activity score of patients who had cyclic exercise was higher. The mean Lysholm activity scores of patients who had cyclic exercise were statistically significantly higher than those of patients who did not undergo cyclic exercise (p<0.01) (Fig. 1). The modified Cincinnati scores of patients in groups 1 and 2 were 28.7 ± 1.44 (range, 24-30) and 26.1 ± 3.27 (range, 21-30). The great majority (96.6%, n=29) of patients in group 1 were found to be in the excellent level compared with 58.6% (n=16) of patients in group 2. The modified Cincinnati scores of patients who had cyclic exercise were statistically significantly higher than those of patients who did not undergo cyclic exercise (p<0.01) (Figure 2). The mean IKDC subjective knee assessment score was 91.9 (range, 83-100) in group 1 and 86.7 (range, 75-100) in group 2. In group 1, it was found that 46.6% (n=14) of patients were excellent, and 50% (n=15) were good, whereas 20.6% (n=6) of group 2 were excellent, and 65.5% (n=15) had good results. The mean IKDC subjective knee assessment scores of patients who underwent cyclic exercise were statistically significantly higher than those of patients who did not undergo cyclic exercise (p<0.01) (Figure 3). According to the IKDC score, 70% (n=21) had normal and 30% (n=9) had near-normal results in Group 1 patients and 56.8% (n=17) had normal and 41.4% (n=12) had near-normal results in Group 2 patients. All patients in both groups who had IKDC scoring during the last follow-up were included in A and B scores (Table 2). There was no statistically significant difference in IKDC scores between the groups (p=0.36). Although there was no statistically significant difference between the two-time IKDC activity scale ratios in the pre-injury period (p=0.43), the activity of patients in group 1 was better than in those in group 2 in the post-treatment period (p=0.04) (Figure 4). The mean degree of flexion was 136.6° (range, 120-160°) in patients in group 1. In group 2, it was 134.4° (120-150°) (p=0.43). Passive Lachman and anterior drawer tests were applied to the patients during their final follow-ups. The results were evaluated as 0-2 mm: (-), 3-5 mm: (+), 6-10 mm: (++), and 11-15 mm (+++) as recommended by the American Medical Association (Table 3-4). Anterior-drawer test and Lachman test (+++) of one patient undergoing Group 1, and three patients in group 2. The results of the ACL stability tests were not statistically significantly different the groups (p>0.05). In the evaluation of thigh atrophy, 15 cm proximal of the upper limit of the patella was measured by comparing the two thigh circles and divided into three degrees according to the determined length differences. The difference between the mean thigh diameters was 1.56 ± 0.91 cm in group 1 and 2.51 ± 1.13 cm in group 2 (Figure 5). The results of thigh atrophy were found to be statistically significantly different between the groups (p<0.01). The patients were asked to jump as far as they could on a single leg, and the test results of the operated and non-operated sides were compared after three repeated tests for both knees. In group 1, 23 patients were detected on 85% and in group 2, 17 patients were found below 85% (Figure 6). The results of the single-leg jump tests were statistically significantly different between the groups (p<0.01).
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2020-01-01 20:18:32