short term results of lateral extra articular tenodesis of the anterolateral ligament by harvesting from the hamstring tendon with modified lemaire method using the ITB fascia with out passing the graft under the lateral collateral ligament compared with classic methode in patients who underwent simultaneous reconstruction of the anterior cruciate ligament
short term results of lateral extra articular tenodesis of the anterolateral ligament by harvesting from the hamstring tendon with modified lemaire method using the ITB fascia with out passing the graft under the lateral collateral ligament compared with classic methode in patients who underwent simultaneous reconstruction of the anterior cruciate ligament
Design
Clinical trial, parallel groups, double-blind, randomized, on 100 patients. In order to randomize, the block randomization method will be used.
Settings and conduct
Patients requiring simultaneous reconstruction of the anterior cruciate ligament and anterior lateral ligament of the knee who refer to Firoozgar Hospital in Tehran will be included in the study. Patients will be randomly divided into 2 groups based on blocks of 10. Patients, responsible for data collection, analysis and outcome assessment will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients requiring simultaneous reconstruction of the anterior cruciate ligament and anterior lateral ligament of the knee, The age range from 18 to 45 years.
Exclusion criteria: Coagulation disorders, Neurological disorders.
Intervention groups
Intervention group 1: The reconstruction method of the anterior lateral ligament of the knee will be the modified Limer method. A flap 8 cm long and 1 cm wide is separated from the proximal part and then the free head of the ITB flap will be fixed with a screw without passing under the LCL, after passing through the canal, in about 40 degrees of knee flexion.
Intervention group 2: After performing ACL repair surgery, they will undergo ACL reconstruction using the classic Limer method. The free head of the ITB flap will be fixed with a screw by passing under the LCL, with the knee flexed at approximately 40 degrees.
Main outcome variables
Anterior Cruciate Ligament Rupture
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230518058225N11
Registration date:2025-04-22, 1404/02/02
Registration timing:prospective
Last update:2025-04-22, 1404/02/02
Update count:0
Registration date
2025-04-22, 1404/02/02
Registrant information
Name
Anahita Sadri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 2543
Email address
sadri.anahita@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-10, 1404/02/20
Expected recruitment end date
2025-09-11, 1404/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
short term results of lateral extra articular tenodesis of the anterolateral ligament by harvesting from the hamstring tendon with modified lemaire method using the ITB fascia with out passing the graft under the lateral collateral ligament compared with classic methode in patients who underwent simultaneous reconstruction of the anterior cruciate ligament
Public title
short term results of lateral extra articular tenodesis of the anterolateral ligament by harvesting from the hamstring tendon with modified lemaire method using the ITB fascia with out passing the graft under the lateral collateral ligament compared with classic methode in patients who underwent simultaneous reconstruction of the anterior cruciate ligament
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients requiring simultaneous reconstruction of the anterior cruciate ligament and anterior lateral ligament of the knee.
Age 18 to 45 years
Exclusion criteria:
Patients with other or multiple ligament injuries
Patients who have suffered re-trauma to the same knee
Patients who underwent surgery with the allograft technique
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into 2 groups. The randomization tool will randomize the table of numbers. Block randomization method will be used for randomization. Block randomization is for the purpose of making sure that exactly equal number of participants enter the study groups. The advantages of block randomization are that the balance of the number of participants in each group is guaranteed. For this purpose, 10 blocks will be formed and in each block 5 people from intervention group and 5 people will be placed in the control group. A total of 10 blocks will be considered to reach the sample size. Blocks contain numbers, numbers represent study groups. Their order will be determined by the statistician from the beginning.
In order to hide the random allocation, opaque envelopes sealed with a random sequence will be used. In this method, each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. became. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be aware that they will be randomly assigned to one of the two study groups, but will not know which method will be provided in that group. Patients will be assigned to one of two groups using a random number table. The person in charge of data collection, the analyst and the outcome evaluator will collect and analyze the information based on groups 1 and 2 and will not know the type of treatment in the groups and will be kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine - Iran University of Medical Sciences (Research Ethics Committee)
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2025-02-09, 1403/11/21
Ethics committee reference number
IR.IUMS.FMD.REC.1403.590
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament tear of the knee
ICD-10 code
S83.7
ICD-10 code description
Injury to multiple structures of knee
Primary outcomes
1
Description
Anterior Cruciate Ligament Rupture
Timepoint
Follow-up 14 days, 2 weeks, 6 weeks, 3 months and 6 months after surgery
Method of measurement
Physician's clinical examination and registration in the checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The reconstruction method of the anterior lateral ligament of the knee will be the modified Limer method, in such a way that after creating the tibial and femoral canals, an autograft is inserted for ACL reconstruction. By accessing the ITB site and identifying the anatomical origin on the femur, a flap 8 cm long and 1 cm wide is separated from the proximal part and then, after creating a transfemoral tunnel in the aforementioned location, the free head of the ITB flap will be fixed with a screw without passing under the LCL, after passing through the canal, in about 40 degrees of knee flexion.
Category
Treatment - Other
2
Description
Intervention group 2: After performing ACL repair surgery, they will undergo ACL reconstruction using the classic Limer method. An 8 cm long and 1 cm wide flap is separated from the proximal part, and after creating a transfemoral tunnel at the aforementioned location, the free head of the ITB flap will be fixed with a screw by passing under the LCL, with the knee flexed at approximately 40 degrees.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar hospital
Full name of responsible person
Farhood Abroosh
Street address
Beh Afarin Ave, Vali Asr Sq
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
h_firoozgar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Safa
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farhood Abroosh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Beh Afarin Ave, Vali Asr Sq
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
farhoodabroosh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hamid Reza Yazdi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Beh Afarin Ave, Vali Asr Sq
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
dr.yazdi۸۸@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farhood Abroosh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Beh Afarin Ave, Vali Asr Sq
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
farhoodabroosh@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