Protocol summary

Study aim
Comparison of Anterior Cruciate Ligament Vascularization after Reconstruction with Hamstring Autograft in two Methods of Maintaining Distal Tibial Insertion with and Without Fixation with Absorbable Interference Screw, based on the Findings of Dynamic Contrast Enhanced MRI,...
Design
Randomized clinical trial, with parallel, double-blind, randomized groups, on 40 patients. Excel software was used for randomization.
Settings and conduct
The present study will be performed in the form of a randomized clinical trial on patients diagnosed with isolated anterior cruciate ligament injury who is a candidate for surgery referred to Shafa Yahyaian Hospital. After the approval of this plan in the ethics committee of the medical school of Iran University of Medical Sciences, and registration in the clinical trial system of the country, written informed ...
Participants/Inclusion and exclusion criteria
Inclusion criteria: - Age over 18 years and under 50 years Patients with ACL tear that is both clinically and MRI-confirmed - Provide written consent to enter the study Criteria for not entering: ACL partial tear Deformity of varus or valgus ACL reconstruction with allograft Previous history of knee surgery History of sensitivity to contrast material Exclusion criteria: Failure to follow post-treatment protocols - Do not refer for follow-up
Intervention groups
The first group in which the distal attachment of the tendons is maintained will be used for fixation by Absorbable Iinterference Screw, which will lead to compression to the wall of the bony canal created in the tibia. the second group :This is the same in the surgical method group, but Absorbable Interference Screw And it is in this way that it is sufficient only to maintain the tibial connection of the tendons.
Main outcome variables
Tibial canal widening, femoral canal widening, ACL diameter, Functional score Womac, tegnerlysholm

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210520051351N2
Registration date: 2022-04-16, 1401/01/27
Registration timing: registered_while_recruiting

Last update: 2022-04-16, 1401/01/27
Update count: 0
Registration date
2022-04-16, 1401/01/27
Registrant information
Name
Mehdi Mohammadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4448 2494
Email address
mehdi.668491@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-15, 1401/01/26
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Anterior Cruciate Ligament Vascularization after Reconstruction with Hamstring Autograft in two Methods of Maintaining Distal Tibial Insertion with and Without Fixation with Absorbable Interference Screw, based on the Findings of Dynamic Contrast Enhanced MRI, a Double Blind Randomized Clinical Trial Study
Public title
Comparison of anterior cruciate ligament vascularization after reconstruction with maintaining distal tibia insertion and application of tibial screw
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-50 years with ACL tear following trauma Patients with ACL tear that is both clinically and MRI-confirmed Provide written consent to enter the study
Exclusion criteria:
ACL partial tear malalignment of varus or valgus ACL reconstruction with allograft Previous history of knee surgery History of sensitivity to contrast material
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method in the present study: For random assignment of patients to study groups, each eligible patient is assigned a number in the order of inclusion in the study. Randomization unit: will be individual Layers of randomization: Using stratified randomization Patients are randomly placed in different groups and random blocks are used for balance in groups. The samples are classified according to the center of the class and then in each class with the help of software to generate a random sequence. Randomization tool: Random numbers according to the number of patients by Excel software The method of constructing a random sequence is selected one by one Explanation of allocation concealment: Patients do not know the type of surgery and the person performing the analysis does not know the type of intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
At the time of obtaining informed consent, patients are explained in an understandable language that they will undergo one or two surgeries in one of two ways. Then a list of random numbers according to the number of patients is prepared by Excel software. This list is then divided into two parts (groups 1 and 2). Each patient will be included in the relevant group according to the number assigned to him / her upon arrival and the envelope with the patient group written on it will be delivered to the relevant doctor. Thus, the patient will not be aware of the type of intervention performed, while the physician will be aware of the type of surgical treatment adopted (double-blind). Random patients are operated on in one of two ways. There is no difference between the two methods in terms of preoperative and postoperative programs. There is no difference between the two methods in terms of pre- and postoperative interventions and the rate of complications. There is no difference between patients in terms of the appearance of organs after surgery. There is no difference in preoperative and postoperative rehabilitation between the two groups. The surgeon is aware of the type of surgery, but in the postoperative period he treats the patients in the same way. The surgeon is aware of the type of surgery, but he treats the patients in the same way in both groups.
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
Mojahedin Islam St. Shafa Yahyaian Hospital
City
تهران
Province
Tehran
Postal code
1157637131
Approval date
2022-03-11, 1400/12/20
Ethics committee reference number
IR.IUMS.REC.1400.1219

Health conditions studied

1

Description of health condition studied
Anterior cruciate ligament tear
ICD-10 code
S83.5
ICD-10 code description
Sprain of cruciate ligament of knee

Primary outcomes

1

Description
Anterior cruciate ligament vascularization rate reconstructed by preserving distal attachment with and without tibia screw
Timepoint
Measurements of vascularization were taken at 6 and 12 weeks after reconstruction
Method of measurement
With Gadolinium enhanced MRI

Secondary outcomes

1

Description
Womac and Tegner-lysholm form score
Timepoint
6 and 12 weeks after reconstruction
Method of measurement
Womac and Tegner-lysholm form score

Intervention groups

1

Description
Intervention group: Patients with ACL tear who undergo ACL reconstruction surgery in a new way with complete preservation of the hamstring tendons from the distal and separation from the proximal. The hamstring tendons are preserved distally and detached from the proximal to the lower extremity on the same side, and are harvest while the distal attachment of the tendons is attached. It is then reconstructed arthroscopically. And the distal connection of the tendon is fixed with a removable screw.
Category
Treatment - Surgery

2

Description
Control group: Patients with ACL tear who undergo ACL reconstruction surgery in a new way with complete preservation of the hamstring tendons from the distal and separation from the proximal. The hamstring tendons are preserved distally and detached from the proximal to the lower extremity on the same side, and are harvest while the distal attachment of the tendons is attached. It is then reconstructed arthroscopically. And the distal connection of the tendon is not fixed with a removable screw.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Yahyaian Hospital
Full name of responsible person
Alireza Askari
Street address
Shafa yahiehian Educational and Medical Center, Mojahedin-e-Islam St., Baharestan Square, Tehran
City
TEHRAN
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Email
mehdi.668491@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences,between Sheikh Fazl ... Nouri and Shahid Chamran, Shahid Hemmat Highway
City
TEHRAN
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Web page address
Grant name
Vice Chancellor for Research, Iran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, 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
Alireza Askari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Mojahedin-e-Islam Street
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Email
aaskari60@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Mohammadpour
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Mojahedin-e-Islam Street
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 3354 2041
Email
mehdi.668491@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Mohammadpour
Position
Non-faculty specialist physician
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shafa yahiehian Educational and Medical Center, Mojahedin-e-Islam St., Baharestan Square, Tehran
City
Tehran
Province
Tehran
Postal code
1157637131
Phone
+98 21 4448 2494
Fax
Email
mehdi.668491@gmail.com
Web page address

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
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
Yes - There is a plan to make this available
Title and more details about the data/document
All variables and all potential data can be shared after identifying individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available to researchers working in academic institutions, and people in industry can apply for it.
Under which criteria data/document could be used
The data can be reviewed and used to improve clinical conditions and maintain patient health and perform meta-analyzes.
From where data/document is obtainable
They can request the author's email or from the research center or university.
What processes are involved for a request to access data/document
Apply by email or post to Iran University of Medical Sciences or Shafa Yahyaian Bone and Joint Reconstruction Research Center.
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