The effect of iliotibial band tightness and its release on postoperative pain after total knee arthrplasty in patients with varusgonarthrosis
Design
The study will be double blind and clinical trial.114 patients will be randomly divided into 3 groups. The groups are parallel. The trial phase is 3
Settings and conduct
Patients Candidate for knee arthroplasty surgery in valiasr Hospital in Arak are divided into 3 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 40 years and up, patients with osteoarthritis and varus of the knee referred for knee arthroplasty, absence of underlying disease, absence of mental illness
Intervention groups
Patients will be evaluated for stiffness at the end of the operation. If they do not have iliotibial band stiffness, they will be placed in the control group. Cases with iliotibial band stiffness will be randomly divided into two groups.
The first group of intervention that iliotibial band will be released and the second group of intervention that iliotibial band will not be released.
Main outcome variables
Pain, joint stability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211207053320N1
Registration date:2022-01-27, 1400/11/07
Registration timing:registered_while_recruiting
Last update:2022-01-27, 1400/11/07
Update count:0
Registration date
2022-01-27, 1400/11/07
Registrant information
Name
Mohammad Zarei dejkooh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3223 1103
Email address
mohammadzarei22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-10, 1400/10/20
Expected recruitment end date
2023-01-10, 1401/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of iliotibial band tightness and its release on postoperative pain after total knee arthrplasty in patients with varusgonarthrosis
Public title
The effect of iliotibial band tightness and its release on postoperative pain after total knee arthrplasty in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
40 years and up
Patients with osteoarthritis and varus of the knee referred for knee arthroplasty
Absence of underlying disease
Absence of mental illness
Exclusion criteria:
Lack of conscious consent
Death
Age
From 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 3 groups using a permuted balanced block randomization method with the size of blocks 3 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. The analysis is done by the analyst and outcome evaluator (two-blind) and the participant. Analysts, evaluators and participants are not aware of the consequences of grouping. Surgery is performed by an assistant of orthopedist. Patients are followed up and variables are reviewed by the project resident
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-11-17, 1400/08/26
Ethics committee reference number
IR.ARAKMU.REC.1400.232
Health conditions studied
1
Description of health condition studied
Knee arthroplasty
ICD-10 code
T84.9
ICD-10 code description
Unspecified complication of internal orthopaedic prosthetic device, implant and graft
Primary outcomes
1
Description
Pain
Timepoint
2 weeks and one month and three months and 6 months and one year later
Method of measurement
Visual analog pain questionnaire
2
Description
Joint stability
Timepoint
2 weeks and one month and three months and 6 months and one year later
Method of measurement
International Knee Documentation Committee (IKDC)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: If they do not have iliotibial band stiffness, they will be included in the control group.Routine surgery will be performed.
Category
Treatment - Surgery
2
Description
Intervention group: Patients are evaluated for stiffness at the end of the operation.The first group of intervention that iliotibial band will be released duration surgery.All peripheral femoral tibia osteophytes should be removed before any soft tissue is released.In tibia, release can be done with osteotomy priority. In femoral part, it is done by sharp dissection.
Category
Treatment - Surgery
3
Description
Intervention group: Patients will be evaluated for stiffness at the end of the operation. second group of intervention that iliotibial band will not be released duration surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Hosseinali Hadi
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
hadi@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Bozorgmanesh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
bozorgmanesh@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hosseinali Hadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
hadi@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Zarei dejkooh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3223 1103
Fax
Email
mohammadzarei22@yahoo.com
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