Evaluation and comparison of postoperative results of anterior cruciate ligament (ACL) double fixation in Tibia by screw and staple with fixation by screwing alone
Evaluation and comparison of postoperative results of anterior cruciate ligament (ACL) double fixation in Tibia by screw and staple with fixation by screwing alone
Design
Randomized Clinical Trial, without Blinding with parallel groups.
Settings and conduct
This clinical trial will be carried out in 1398. 30 patients who will be refered to Kashani and Alzahra hospitals who have anterior cruciate ligament rupture and require transplant reconstruction surgery and will be eligible for inclusion criteria will be selected. In this study, blinding will not occur. Patients will be divided into two groups. The first group consists of patients undergoing ACL rehabilitation using screw and staple fixation, and the second group consisting of patients undergoing ACL fixation with a screw (patients are under restoration arthroscopy) after surgery, patients undergo physical therapy three times a week until the 6th week during the first week.
Participants/Inclusion and exclusion criteria
1. Age between 18 to 50 years
2. Patients with anterior cruciate ligament rupture
Non-inclusion criteria:
1. If the patient will be in need for knee osteotomy
2. If several other ligaments, including the other knee ligaments, will be involved
3. Do not suffer from autoimmune diseases or immunocompromised conditions
Intervention groups
The first group consists of patients undergoing acl rehabilitation with the use of screw and staple fixation and the second group consisting of patients undergoing acl rehabilitation with the use of fixation with screw (patients undergo surgery under arthroscopy), after surgery In the first week, both groups will undergo physiotherapy three times a week until the 6th week
Main outcome variables
Return to daily activities, the degree to which patients will be satisfied with the function of the knee, and the extent to which the surgery will reduce their expected activities.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N28
Registration date:2019-04-07, 1398/01/18
Registration timing:prospective
Last update:2019-04-07, 1398/01/18
Update count:0
Registration date
2019-04-07, 1398/01/18
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of postoperative results of anterior cruciate ligament (ACL) double fixation in Tibia by screw and staple with fixation by screwing alone
Public title
Evaluation and comparison of postoperative results of anterior cruciate ligament (ACL) double fixation in Tibia by screw and staple with fixation by screwing alone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 50 years
Patients with anterior cruciate ligament rupture
Consciousness of Patients to Participate in the Study
The first time that the knees are in trouble
Exclusion criteria:
Need of osteotomy
If several other ligaments, including the other knee ligaments, are involved
Do not suffer from autoimmune diseases or immunocompromised conditions
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Randomization block, randomization unit: Individual, Random layer: not done Randomization, tool: Random sequence generation software (Excel), How to create random sequence: Using random blocks, each block contains 4 people And assign a number from 1 to 6 to each block
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
Isfahan University of Medical Sciences, Azadi Square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-10-08, 1396/07/16
Ethics committee reference number
IR.MUI.MED.REC.1397.074
Health conditions studied
1
Description of health condition studied
Sprain of unspecified cruciate ligament of knee
ICD-10 code
S83.50
ICD-10 code description
Sprain of unspecified cruciate ligament of knee
Primary outcomes
1
Description
Return to daily activities
Timepoint
6 weeks after surgery
Method of measurement
International Knee Documentation Committee Questionnaire (IKDC)
2
Description
Patient satisfaction from knee function
Timepoint
6 weeks after surgery
Method of measurement
International Knee Documentation Committee Questionnaire (IKDC)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group first: Includes patients who are undergoing ACL rebuilding using bolted and staple fixation
Category
Treatment - Devices
2
Description
Intervention group second: Including patients undergoing ACL fixation with a screw (patients undergo surgery under arthroscopy)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr Hamid Moosavi
Street address
Alzahra hospital, Sofe street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81747-86398
Phone
+98 31 1668 5555
Email
hos.lolagar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of Medical Sciences, Hezar jareeb street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan 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
Dr Hamid Moosavi
Position
Associated Proffessor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Alzahra Hospital, Sofe Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1625 5555
Email
h_mousavi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Hamid Moosavi
Position
Associated Proffessor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Alzahra Hospital, Sofe Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1625 5555
Email
h_mousavi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Hamid Moosavi
Position
Associated Proffessor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Alzahra Hospital, Sofe Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1625 5555
Email
h_mousavi@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
Whole data will be shared
When the data will become available and for how long
immediately after publishing manuscript
To whom data/document is available
for all who need this data.
Under which criteria data/document could be used
Use of data is allowed for all individuals and for all purposes.
From where data/document is obtainable
Receive article from the corresponding author of the article.
What processes are involved for a request to access data/document