Comparison of kinematics and kinetic gait, after knee surgery with ACL and Anterolateral Ligament Reconstruction technique, and Lemire - tenodesis technique
The purpose of this study is to evaluate the rotation and internal pressure of the knee after surgery with ACL and Anterolateral Ligament Reconstruction technique, and Lemire tenodesis technique
Design
A randomized trial with two parallel group design of 20 patients which is randomized with "random allocation" software.
Settings and conduct
Patients with clinical sign candidates for knee surgery with ACL and anterolateral ligament reconstruction referred to the Orthopedic Clinic of Isfahan University of Medical Sciences are divided into two groups. The cruciate ligament reconstruction method will be used for The first group, and in the second group, the Lemire tenodesis technique will be used. Gait analysis will be performed for each group before and 6 month after surgery to compare kinetic and kinematic data.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Consent to participate in the study; Age range 20 to 40 years; The patient is able to walk and stand; The patient does not have any other medical problem that causes pain and prevents her from walking
Inclusion criteria:
History of knee replacement; Any lower limb fractures in the last 6 months
Metabolic bone diseases
Intervention groups
In this study, 20 patients with unilateral anterior cruciate ligament rupture of the knee and a pivot shift test of the third degree who are candidates for anterior cruciate ligament reconstruction surgery with anterolateral ligament reconstruction will participate. One group will perform anterior cruciate ligament reconstruction with hamstring autograft and anterolateral ligament reconstruction, and the other group will perform anterior cruciate ligament reconstruction with hamstring autograft and anterolateral ligament by Lemire
tenodesis method using allograft.
Main outcome variables
Evaluation of kinetic and kinematic data
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180729040636N4
Registration date:2021-05-01, 1400/02/11
Registration timing:registered_while_recruiting
Last update:2021-05-01, 1400/02/11
Update count:0
Registration date
2021-05-01, 1400/02/11
Registrant information
Name
Hossein Akbari aghdam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2085
Email address
akbariaghdam@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of kinematics and kinetic gait, after knee surgery with ACL and Anterolateral Ligament Reconstruction technique, and Lemire - tenodesis technique
Public title
Comparison of kinematics and kinetic gait, after knee surgery with ACL and Anterolateral Ligament Reconstruction technique, and Lemire - tenodesis technique
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for knee surgery with ACL and Anterolateral Ligament Reconstruction admitted in the Kashani hospital. -Signing the consent form.
Exclusion criteria:
knee arthroplasty
Knee surgery in the last 12 months
Lower limb fractures in the last 6 months
Bilateral anterior cruciate ligament injury of the knee
Bucket-handle meniscal tear
injection of intra-articular in the last 6 months
Metabolic bone diseases
osteomalacia
Individuals with an underlying disease
People with osteoporosis
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were allocated into intervention or control group using block randomization method to keep an even randomization ratio of (1:1). If the patient had inclusion criteria and did not excluded from the study according to above mentioned protocol, the random number generating software was used to determine their designated group. Numbers were between 0-9. If the number was even, the letter "A" was wrote at the top of their checklist by the examining physician, and if the number was odd, the letter "B" was used. Then, the next patient had to be assigned to the opposite group. This process repeated for the upcoming patients and continued until we reached our estimated sample size. After completing the study and before starting the data analysis process, the encrypted letters were revealed by the pharmaceutical company. The letter "A" was assigned to the intervention group and the letter "B" was assigned to the control group.
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 Isfahan University of Medical Sciences
Street address
Hezar Jerib street, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-04-14, 1400/01/25
Ethics committee reference number
IR.MUI.MED.REC.1400.028
Health conditions studied
1
Description of health condition studied
Anterolateral Ligament Reconstruction
ICD-10 code
S83.51
ICD-10 code description
Sprain of anterior cruciate ligament of knee
Primary outcomes
1
Description
internal forces of knee compartments
Timepoint
Before the intervention and 6 months after
Method of measurement
motion capture system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Reconstruction of the anterior cruciate ligament with a hamstring autograft
Category
Treatment - Surgery
2
Description
Intervention group: Reconstruction of anterior cruciate ligament using hamstring autograft and anterolateral ligament by Lemir method
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Hossein Akbari Aghdam
Street address
Isfahan medical school, Hezarjeribstreet, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7654
Email
Akbariaghdam@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hezar Jerib street, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Akbari aghdam
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Nikan appartment , east allame amini ave ,ghadir park,isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3620 2085
Fax
Email
akbariaghdam@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Akbari aghdam
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Nikan appartment , east allame amini ave ,ghadir park,isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3620 2085
Fax
Email
akbariaghdam@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Akbari aghdam
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Nikan appartment , east allame amini ave ,ghadir park,isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3620 2085
Fax
Email
akbariaghdam@med.mui.ac.ir
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
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data related to the results of data analysis and review can be shared
When the data will become available and for how long
3 months after the results are published in an international journal
To whom data/document is available
For researchers only
Under which criteria data/document could be used
Individuals are allowed to use the data for research purposes.
From where data/document is obtainable
corresponding author
akbariaghdam@mui.ac.ir
What processes are involved for a request to access data/document
After requesting and confirming it, it will take about two weeks to send the data.