Comparison of the results of anteromedial and anterolateral tibial tunnel methods in posterior cruciate ligament reconstruction: a randomized clinical trial
To compare the results of anteromedial and anterolateral tibial tunnel methods in posterior cruciate ligament reconstruction
Design
This is a randomized clinical trial with control group, in which eligible patients will be randomly assigned through the block randomization to the intervention groups
Settings and conduct
This study will be performed in the Besat Hospital in Hamadan city on 36 eligible patients. The patients will be randomly assigned to the intervention groups through the block randomization. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years
Rupture of the posterior cruciate tendon
Exclusion criteria:
Coagulopathy disorder
Intervention groups
Intervention group 1:
Arthroscopic surgery of the knee in order to reconstruct the posterior cruciate ligament of the knee by using single-strand Achilles graft through the medial anterior tibial tunnel while the knee is in 90 degree flexion.
Intervention group 2:
Arthroscopic surgery of the knee in order to reconstruct the posterior cruciate ligament of the knee by using single-strand Achilles graft through the medial lateral tibial tunnel while the knee is in 90 degree flexion.
Main outcome variables
Primary outcome:
Average pain score, the average time to return to daily activities, the average range of motion limitation
Secondary outcome:
Hematoma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N472
Registration date:2023-05-03, 1402/02/13
Registration timing:prospective
Last update:2023-05-03, 1402/02/13
Update count:0
Registration date
2023-05-03, 1402/02/13
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of anteromedial and anterolateral tibial tunnel methods in posterior cruciate ligament reconstruction: a randomized clinical trial
Public title
Comparison of the results of anteromedial and anterolateral tibial tunnel methods in posterior cruciate ligament reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years
Rupture of the posterior cruciate tendon
Exclusion criteria:
Coagulopathy disorder
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-04-29, 1402/02/09
Ethics committee reference number
IR.UMSHA.REC.1402.040
Health conditions studied
1
Description of health condition studied
Rupture of the posterior cruciate tendon
ICD-10 code
M23.62
ICD-10 code description
Other spontaneous disruption of posterior cruciate ligament of knee
Primary outcomes
1
Description
Average pain score
Timepoint
In the fourth and eighth weeks and the third month after surgery
Method of measurement
Using a visual analog scale (VAS)
2
Description
The average time to return to daily activities
Timepoint
In the fourth and eighth weeks and the third month after surgery
Method of measurement
By taking a history
3
Description
The average range of motion limitation
Timepoint
In the fourth and eighth weeks and the third month after surgery
Method of measurement
Using the Lysholm Knee Scoring Scale
Secondary outcomes
1
Description
Hematoma
Timepoint
In the fourth and eighth weeks and the third month after surgery
Method of measurement
With clinical examination
Intervention groups
1
Description
Intervention group 1: Arthroscopic surgery of the knee in order to reconstruct the posterior cruciate ligament of the knee by using single-strand Achilles graft through the medial anterior tibial tunnel while the knee is in 90 degree flexion.
Category
Treatment - Surgery
2
Description
Intervention group 2: Arthroscopic surgery of the knee in order to reconstruct the posterior cruciate ligament of the knee by using single-strand Achilles graft through the medial lateral tibial tunnel while the knee is in 90 degree flexion.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Dr Alireza Naderi
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
alirezanader97@gimail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
Hamadan University o
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Alireza Naderi
Position
Resident of Orthopedic
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
alirezanader97@gimail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Ghorbani Amjad
Position
Orthopedist
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
ghorbaniamjad@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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