Comparison of anterior cruciate ligament perfusion after reconstruction with hamstring autograft in two methods of preservation or isolation of tibial junction based on dynamic contrast enhanced MRI findings of a randomized clinical trial study
Anterior cruciate ligament blood supply after reconstruction with hamstring autograft in two methods of maintaining or isolating tibial junction based on findings
dynamic contrast enhanced MRI
Is compared
Design
a clinical trial with a control group, with parallel groups, double-blind, approved, on 40 patients. Excel software Rand function was used for scanning.
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 consent will be obtained from patients who are eligible to participate in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients aged 18-40 years who have suffered ACL isolation following trauma.
Exclusion criteria:
Knee or leg fractures
Simultaneous ligament injury
Meniscus damage that needs to be repaired and affects postoperative reflux
Trauma to the knee or leg
- Clear deformity in the knee or leg
History of previous knee or leg surgery
Intervention groups
Control group: Patients with ACL tear who undergo ACL reconstruction with complete separation of the hamstring tendons from the distal and proximal. The case group, while the distal attachment of the tendon is preserved, is detached from the proximal and harvested out and reconstructed while maintaining the distal attachment.
Comparison of anterior cruciate ligament perfusion after reconstruction with hamstring autograft in two methods of preservation or isolation of tibial junction based on dynamic contrast enhanced MRI findings of a randomized clinical trial study
Public title
Comparison of anterior cruciate ligament blood flow after reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-40 years with ACL tear following trauma
Exclusion criteria:
Knee or leg fracture
Simultaneous ligament injury
Meniscus damage that needs to be repaired and affects postoperative rehabilitation.
Previous trauma to the knee or leg
Obvious deformity in the knee or leg
History of previous knee or leg surgery
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method in the present study: Simple randomization is such that the form is divided among the control and intervention groups once.
Randomization unit: will be personal.
Visualization layers: Using randomization layers (stratified randomization) Using random options is placed in different groups and image 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
Visualization tool: Random number table
How to construct a random sequence is selected one by one
Explanation of Concealment of Concealment Allocation: The surgical material and the person performing the analysis are not aware of 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 method 1 or 2 in one of these two hospitals. 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 complications. There is no difference between patients in terms of the appearance of extremity 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 visit the patient 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
2021-03-09, 1399/12/19
Ethics committee reference number
IR.IUMS.REC.1399.1398
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
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 , Tegner-lysholm form
Intervention groups
1
Description
Control group: Patients with ACL tear who undergo normal ACL reconstruction surgery with complete separation of the hamstring tendons from the distal and proximal attachment. The distal and proximal hamstring tendons are detached from the lower extremity on the same side and harvested and reconstructed arthroscopically.
Category
Treatment - Surgery
2
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.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahyaian Hospital
Full name of responsible person
Alireza Askari
Street address
Tehran, Baharestan Square, Mojahedin-e-Islam St., Shafaiehian Educational and Medical Center