Evaluation of the effectiveness of placing the proximal 1/3 anterior cruciate ligament stump in individuals with complete anterior cruciate ligament rupture in preventing an increase in tibial tunnel diameter: a randomized controlled clinical trial
Evaluation of the effectiveness of inserting the remaining of 1/3 proximal stump of anterior cruciate ligament(ACL) in individuals with ACL tear in prevention of the tibial tunnel diameter enlargement
Design
IIn this phase 3 study, a parallel, double-blind, randomized controlled clinical trial of 30 patients undergoing ACL reconstruction will be evaluated. Patients were randomly divided into two groups, intervention (with residues) and control (without residues) using Random allocation software version 2 with the link (https://random-allocation-software.software.informer.com/2.0/) ) Are allocated.
Settings and conduct
This study will be performed on 30 patients who are candidates for ACL reconstruction who refer to the Firoozgar Hospital in Tehran from the 23 october 2021 to 22 December 2022. Patients and researchers (analyzers of results) will be blind to the received surgical procedure.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Age range 18-40 years
2. Patients with complete anterior cruciate ligament injury
3. Patients without a history of anterior cruciate ligament surgery
4. consent of patients to participate in the study
Exclusion criteria:
1. Patients with traumatic knee fractures
2. Joint diseases (grade 3 and 4 cartilage injury) of the knee on the same side of the operated
3. Patients with rheumatoid arthritis and arthritis and patients with axial malalignment
4. or patients with simultaneous ACL and meniscus injury who have undergone meniscus repair.
Intervention groups
Intervention group: Patients for whom 1/3 of the proximal remnants of the anterior cruciate ligament ACL are placed in the tibial canal during surgery. control group : patients whose surgery did not use ACL residues.
Main outcome variables
Average change in tibial canal diameter; Frequency of Anterior drawer test (ADT) negative ; frequency of pivot-shift test negative
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200802048270N1
Registration date:2021-11-12, 1400/08/21
Registration timing:prospective
Last update:2021-11-12, 1400/08/21
Update count:0
Registration date
2021-11-12, 1400/08/21
Registrant information
Name
Ahmad Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1321
Email address
azizi3981@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of placing the proximal 1/3 anterior cruciate ligament stump in individuals with complete anterior cruciate ligament rupture in preventing an increase in tibial tunnel diameter: a randomized controlled clinical trial
Public title
observation of prevention of tibia tunneling
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 40 years old
complete anterior cruciate ligament
Consent to participate in the study
Exclusion criteria:
history of previous surgery due to anterior cruciate ligament injury
History of surgery on other lower limbs
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random chain construction of two groups of 15 A (intervention group) and B (control group) using Excel software will be used. In a column of 15 letters A and 15 letters B and in the adjacent column with the Rand command, make 30 random numbers. Arrange both columns in random order from large to small. The sequence of letters A and B will be the random sequence used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researchers analyzing the results will be blind to the surgical procedure.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-03-06, 1399/12/16
Ethics committee reference number
IR.IUMS.FMD.REC.1399.787
Health conditions studied
1
Description of health condition studied
disruption of anterior cruciate ligament of knee
ICD-10 code
M23.61
ICD-10 code description
Other spontaneous disruption of anterior cruciate ligament of knee
Primary outcomes
1
Description
Tibial canal diameter change 1
Timepoint
The diameter of the tibial tunnel is measured during the operation and 12 months after the operation.
Method of measurement
The diameter of the tibial tunnel is measured during surgery and 12 months after surgery using a CT scan by an orthopedic surgeon.
Secondary outcomes
1
Description
Frequency of anterior sliding test negative
Timepoint
12 months after surgery
Method of measurement
Clinical examinations
2
Description
Frequency of negative pivot-shift test
Timepoint
12 months after surgery
Method of measurement
Clinical examinations
3
Description
Lysholm scale score
Timepoint
12 months after surgery
Method of measurement
Lysholm scale questionnaire
4
Description
Ikdc scale score
Timepoint
12 months after surgery
Method of measurement
Ikdc scale questionnaire
5
Description
Frequency of Lachman test negative
Timepoint
12 months after surgery
Method of measurement
Clinical examinations
Intervention groups
1
Description
Patients who during surgery, 1/3 of the proximal remnants of the anterior cruciate ligament (ACL) stump remain in the tibial canal.
Category
Treatment - Surgery
2
Description
Control group: Patients without proximal remnants of the anterior cruciate ligament (ACL) stump in the tibial canal
Valiasr Square, Karim Khan Zand St., Beh Afarin St, Tehran
City
Tehran
Province
Tehran
Postal code
4871115937
Phone
+98 21 8214 1000
Email
dr.yazdi88@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ahmad Azizi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Valiasr Square, Karim Khan Zand St., Beh Afarin St, Tehran
City
Tehran
Province
Tehran
Postal code
4871115937
Phone
+98 21 8214 1000
Email
azizi3981@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
Unidentifiable personal data of participants will be shared upon request upon completion of the study. The protocol of surgery and study will be provided to the researchers in the form of a report after the end of the study. Statistical analysis of the data of this study will be shared in the form of a report after the end of the study. Informed design consent form, study clinical reports and codes used in the analysis will be shared in the form of a report at the end of the study.
Part of the data, such as information about the main outcome or the like, will be published collectively without identifying individuals in the form of an article.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
researchers
Under which criteria data/document could be used
Use to enhance knowledge and researchers without permission to manipulate documents
From where data/document is obtainable
Firoozgar Hospital
What processes are involved for a request to access data/document
Send a written request and then review and if the request is approved, the documents will be delivered. (Maximum one month)