Evaluation of iliotibial band tenodesis with two surgical methods Arnold and Coker and modified iliotibial band Lemaire tenodesis in patients with Anterior Cruciate Ligament rupture
Comparison of the results of iliotibial band tendon grafting with two surgical methods, Arnold and Coker, and modified iliotibial band tendinosis using the Lemaire method in patients with anterior cruciate ligament rupture.
Design
Clinical trial, parallel groups, unblinded, on 48 patients, non-randomized
Settings and conduct
In this unblinded clinical trial, patients referred to Shohada Tajrish Hospital with anterior cruciate ligament rupture will be non-randomly divided into two groups using the Arnold and Coker method or the modified iliotibial band tenosynovitis method using the Lemaire method, at the discretion of the surgeon. Patients will be evaluated one year after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with anterior cruciate ligament rupture who have a positive Pivot Shift test and a Pivot Shift score of 3. Exclusion criteria: knee osteoarthritis, simultaneous injury to multiple ligaments.
Intervention groups
The first intervention group will undergo surgery using the Arnold and Coker method. In this technique, the iliotibial band, a connective tissue in the outer thigh, is separated from its normal position and used as a substitute for the anterior cruciate ligament. The iliotibial band tissue is precisely transplanted at the site of the anterior cruciate ligament injury to restore knee function and stability. The second intervention group in this study will undergo surgery using the modified iliotibial band tendosynovectomy method, as described in the Lemaire method. In this technique, the iliotibial band is separated from its natural place in the outer thigh and precisely transplanted at the site of the anterior cruciate ligament injury.
Main outcome variables
Knee score, quality of life, knee function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250307064959N1
Registration date:2025-04-08, 1404/01/19
Registration timing:registered_while_recruiting
Last update:2025-04-08, 1404/01/19
Update count:1
Registration date
2025-04-08, 1404/01/19
Registrant information
Name
Soroush Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 23871
Email address
soroush.hosseinik93@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-10, 1403/12/20
Expected recruitment end date
2026-03-11, 1404/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of iliotibial band tenodesis with two surgical methods Arnold and Coker and modified iliotibial band Lemaire tenodesis in patients with Anterior Cruciate Ligament rupture
Public title
A study of two surgical methods for anterior cruciate ligament rupture.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with anterior cruciate ligament rupture who have a positive Pivot Shift test and a Pivot Shift score of 3
Ethics Committee of the Faculty of Medicine, Shahid Beheshti University of Medical Sciences
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
19394631
Approval date
2025-02-04, 1403/11/16
Ethics committee reference number
IR.SBMU.MSP.REC.1403.633
Health conditions studied
1
Description of health condition studied
Cruciate ligament rupture
ICD-10 code
S83.5
ICD-10 code description
Sprain of cruciate ligament of knee
Primary outcomes
1
Description
knee score
Timepoint
Before the intervention and one year after ending the intervention
Method of measurement
International Knee Documentation Committee scale, Lysholm Knee Score and Knee injury and Osteoarthritis Outcome Score
2
Description
Knee function
Timepoint
Before the intervention and one year after ending the intervention
Method of measurement
International Knee Documentation Committee scale, Lysholm Knee Score and Knee injury and Osteoarthritis Outcome Score
3
Description
quality of life
Timepoint
Before the intervention and one year after ending the intervention
Method of measurement
International Knee Documentation Committee scale, Lysholm Knee Score and Knee injury and Osteoarthritis Outcome Score
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group in this study will undergo surgery using the Arnold and Coker method, which uses the iliotibial band to repair or reconstruct the anterior cruciate ligament (ACL). This surgical procedure is performed specifically in patients with ACL tears and in cases where a tendon graft from other areas of the body is not possible. In this technique, the iliotibial band, a connective tissue in the outer area of the thigh, is removed from its place and used as a replacement for the anterior cruciate ligament. The surgery is performed under general anesthesia and is usually performed arthroscopically (minimally invasive) to minimize damage to surrounding tissues. The iliotibial band tissue is precisely grafted to the site of the ACL injury to restore function and stability of the knee. This surgery uses an arthroscope and specialized surgical instruments that facilitate minimally invasive surgery. Also, surgical needles and sutures are used to attach the iliotibial band to the femur and tibia bones.
Category
Treatment - Surgery
2
Description
The second intervention group in this study will undergo surgery with the modified iliotibial band tenosynovectomy method using the Lemaire technique, which is used to repair or reconstruct the anterior cruciate ligament. This surgical technique is a modified technique of the Lemaire technique in which the iliotibial band is used as a replacement for the damaged anterior cruciate ligament. In this technique, the iliotibial band is separated from its natural location on the outer thigh and is grafted precisely at the site of the anterior cruciate ligament injury. The surgery is performed under general anesthesia and is usually performed arthroscopically, which causes minimal damage to the surrounding tissues. In this method, specialized surgical instruments are used to separate the iliotibial band and graft it to the femur and tibia bones. Surgical needles and sutures are also used to hold the iliotibial band in place at the site of the anterior cruciate ligament injury.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-ye Tajrish Hospital
Full name of responsible person
Mehrdad Sedighi
Street address
Valiasr street, Tajrish square
City
Tehran
Province
Tehran
Postal code
1989934184
Phone
+98 21 25719
Email
Pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Arabi street, velenjak
City
Tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soroush Hoseini
Position
Rezident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Valiasr street, Tajrish square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
soroush.hosseinik93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Sedighi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Vliast street, Tajrish square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
mehrdad_1330@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Sabbaghzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Valiasr street, Tajrish square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
dramirsabbaghzadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Maintaining patient privacy and confidentiality
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Only information related to the study protocol, statistical analysis plan, and clinical study report will be made available to other researchers to guide future studies (and not publicly).
When the data will become available and for how long
After publishing the article
To whom data/document is available
Researchers, students, and professors in the field of orthopedics
Under which criteria data/document could be used
For use in future research and if the source is cited.
From where data/document is obtainable
Corresponding author Dr. Mehrdad Sedighi
mehrdad_1330@yahoo.com
What processes are involved for a request to access data/document
Send a request via email to the corresponding author, stating the reason for the request and how the data will be used.