1. Home
  2. Approved trials
  3. » فارسی

Comparison of clinical results using hamstring versus quadriceps tendon graft and versus bone-patella tendon in anterior cruciate ligament reconstruction , a randomized clinical trial

Protocol summary

Study aim
In this plan, important results are obtained that show which graft is better for the reconstruction of the ACL.
Design
This research is a prospective interventional study of the type of randomized controlled clinical trial with three arms (3-arm RCT) which aims to compare the clinical results of anterior cruciate ligament reconstruction with hamstring tendon, quadriceps tendon and patella tendon.The protocol of this study will be based on SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials) guidelines. This study is a randomized study with 3 arms (3 treatment groups) in a parallel manner, in which 63 participants who meet the study entry and exit conditions are selected and are followed up for 12 months after the intervention.
Settings and conduct
Army employees and soldiers who entered the study based on the entry and exit criteria, their demographic information is obtained by interviewing and completing a questionnaire, then after randomization, random allocation, and concealment, they are randomly divided into 3 groups, and each group undergoes a type of operation. Surgery is done by a surgeon and with a fixation method, and immediately after the operation, as well as the follow-up periods of 3, 6, and 12 months, they are examined and asked about function , pain level, and clinical examinations of ligament laxity, and at the end of the patients' information It is subjected to statistical analysis by SPSS program.
Participants/Inclusion and exclusion criteria
Patients who undergo ACL resection surgery, Age above 18 years, BMI ≤ 35, ACL tear
Intervention groups
Patients who undergo ACL resection surgery from 1400 to 1402.
Main outcome variables
Need for re-surgery, Lachman test status, pivot shift test status, anterior traction test status, score, anterior knee pain, knee range of motion, satisfaction level, time to return to normal activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230716058805N1
Registration date: 2023-07-31, 1402/05/09
Registration timing: registered_while_recruiting

Last update: 2023-07-31, 1402/05/09
Update count: 0
Registration date
2023-07-31, 1402/05/09
Registrant information
Name
Nima Hoseinizare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2236 9615
Email address
nimazr70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical results using hamstring versus quadriceps tendon graft and versus bone-patella tendon in anterior cruciate ligament reconstruction , a randomized clinical trial
Public title
Comparison of different methods of knee anterior cruciate ligament surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients who undergo anterior cruciate ligament resection surgery 2. Over 18 years of age 3. BMI ≤ 35 Willingness and ability to prepare a written consent form 4. Willingness and ability to perform subjective evaluations and have the ability to understand written questionnaires 5, Suffering from rupture 6. Present May he not take any medicine that changes knee symptoms throughout the study until the end. 7. Willingness and ability to agree to the conditions related to the study and procedures and visits.
Exclusion criteria:
1. Injuries associated with ACL such as torn meniscus or posterior cruciate ligament 2. Follow-up of patients under 12 months 3, Patients who had complications such as thrombosis or embolism during or immediately after surgery 4, Patients who do not come for follow-up 5, Diseases High-risk medical condition such as kidney, liver and heart failure 6, History of addiction 7, A history of any surgery related to the knee 8. Contraindications for imaging and MRI 9. Mental disorders 10. Progressive neurological disorders 11. Having pain in another place that causes disturbance in the assessment of shoulder pain
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 63
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly divided into three groups 1:1:1. Each patient who enters the study will be assigned a unique number. Using the method of balanced consecutive blocks (Permuted Balanced Block Randomization) and the command of random numbers in Microsoft Office Excel 365 software, the table of random assignment of each patient to one of three different surgical groups is prepared. Patients based on their unique number specified in the patient report form; They are divided into one of three groups. Concealment: The random numbers generated for assigning referring patients to different treatment groups will be hidden from the opinion and information of the project manager and collaborators until the end of the study, and will be revealed after data analysis. In order to hide the sequence of generated random numbers, they are assigned to different treatments through pre-determined codes, and the clinical colleagues do not have any knowledge of the defined assigned code when prescribing. The orthopedic surgeon will be informed of the patient's assigned group on the day of the operation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Army Medical Sciences University
Street address
NO. 7,West 5th AVE, Morvarid BLVD, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998745363
Approval date
2022-08-21, 1401/05/30
Ethics committee reference number
IR.AJAUMS.REC.1401.075

Health conditions studied

1

Description of health condition studied
anterior cruciate ligament tear
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Army employees and soldiers who have ruptured the anterior cruciate ligament, their demographic information is obtained by interviewing and completing a questionnaire, then after randomization, random allocation, and concealment, they are randomly divided into 3 groups, and each group undergoes a type of surgery by They are placed by a surgeon and with a fixation method, and immediately after the operation, as well as the follow-up periods of 3, 6, and 12 months, they are examined and asked about function (Lee Scholem questionnaire), pain level, and clinical examinations of ligament laxity, and at the end, the patient information is provided by the program. SPSS is subjected to statistical analysis.
Timepoint
Immediately after the operation, as well as the follow-up periods of 3, 6, and 12 months
Method of measurement
They are examined and questioned in terms of function (Lee Scholem questionnaire), pain level and clinical examinations for ligament laxity.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First: 21 patients undergo anterior cruciate ligament surgery with patellar tendon.
Category
Treatment - Surgery

2

Description
Intervention group: The second group: 21 patients undergo hamstring surgery.
Category
Treatment - Surgery

3

Description
Intervention group: Third: 21 patients undergo anterior cruciate ligament surgery with quadriceps tendon.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Army hospitals (501) in Tehran
Full name of responsible person
Nima Hoseinizare
Street address
No 7, 5th West AVE, Morvarid Street, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998745363
Phone
+98 21 2236 9615
Email
nimazr70@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Doctor Heidari
Street address
Shahid Etemadzadeh St, West Fatemi St., Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
nimazr70@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Nima hoseinizare
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No. 7, 5th West AVE, Morvarid ST, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998745363
Phone
+98 21 2236 9615
Email
nimazr70@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Nima Hoseinizare
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No.7, 5th West AVE, Morvarid ST, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998745363
Phone
+98 21 2236 9615
Email
nimazr70@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Nima Hoseinizare
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
No 7, 5th West AVE, Morvarid ST, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998745363
Phone
+98 21 2236 9615
Email
nimazr70@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...