Assessment the effect of high tibial osteotomy (HTO) surgery on the analysis of gate parameters of patients referred to Imam Hossein Hospital between 1400 and 1402.
Determining the effect of high tibial osteotomy (HTO) surgery on the analysis of gate parameters of patients referred to Imam Hossein Hospital
Design
Clinical trial with control group, with parallel groups, randomized, phase 2 on 15 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Before surgery, the patients referred to Imam Hossein Hospital were subjected to gait analysis using a motion analysis device, then tibial osteotomy (HTO) surgery will be performed and within 6 months after the surgery and when The patients should be able to walk and the tibia completely fused. Again, they were subjected to gait analysis using the motion analysis device, then the information was collected and compared using the checklist filled before and after the operation. It will be analyzed using descriptive and average statistical methods and chi-square statistical test, Fisher's exact test, paired t-test and independent t-test.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pain and disability caused by osteoarthritis, Evidence of arthritis changes limited to a one compartment in the knee and Exiteria criteria: Bone loss in the medial compartment is more than 2-3 mm, F.C > 15° Knee flexion <90° , The need to correct alignment more than 20° , Inflammatory arthritis, Symptomatic peripheral vascular diseases, Lateral Tibia subluxation > 1cm.
Intervention groups
Single group study. Intervention: High tibial osteotomy (HTO) surgery.
Main outcome variables
The length of a step; The duration of one step; Number of steps; Step speed
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20230725058922N1
Registration date:2023-12-12, 1402/09/21
Registration timing:prospective
Last update:2023-12-12, 1402/09/21
Update count:0
Registration date
2023-12-12, 1402/09/21
Registrant information
Name
Ali Saeed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3378 3049
Email address
ali.saeed1410@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of high tibial osteotomy (HTO) surgery on the analysis of gate parameters of patients referred to Imam Hossein Hospital between 1400 and 1402.
Public title
Assessment the effect of high tibial osteotomy (HTO) surgery on the of gate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain and disability caused by osteoarthritis
Evidence of arthritis changes limited to a one compartment in the knee
Exclusion criteria:
Bone loss in the medial compartment is more than 2-3 mm
F.C > 15°
Knee flexion <90°
The need to correct alignment more than 20°
Inflammatory arthritis
Symptomatic peripheral vascular diseases
Lateral Tibia subluxation > 1cm
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
Before surgery and six months after surgery
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Do not have
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beshti university of medical sciences,Aarabi st,Daneshjo blvd,Valenjak,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
IR.SBMU.MSP.REC.1402.135
Health conditions studied
1
Description of health condition studied
Genu Varum and GenuValgum
ICD-10 code
1.Q74
ICD-10 code description
Congenital malformation of knee
Primary outcomes
1
Description
Gate before and after surgery
Timepoint
Before surgery and six months after surgery
Method of measurement
Measurement by gate analysis parameters: step length, step speed, number of steps per minute, duration
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: High tibial osteotomy (HTO) surgery. Six months after the surgery, the patient goes to measure the gate by the parameters of the gate analysis and the results are obtained
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Doctor Mohammad Mahdi Omidian
Street address
Imam Hossein Hospital ; Madani Ave ; Tehran Town
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Fax
Email
info@ehmc.ir
Web page address
https://ehmc.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Doctor Mohammad Mahdi Omidian
Street address
Shahid Beheshti University of Medical Sciences, El Arabi St.,Daneshjo Blvd., Valenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2387 2357
Fax
+98 21 2243 9783
Email
info@sbmu.ac.ir
Web page address
https://sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mehdi Omidian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Hossein Medical Research Training Center, Shahid Madani St. Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 2597
Email
Omid_medicine@yahoo.com
Web page address
https://ehmc.sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mehdi Omidian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Hossein Medical Research Training Center, Shahid Madani St. Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 2597
Email
Omid_medicine@yahoo.com
Web page address
https://ehmc.sbmu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mehdi Omidian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Imam Hossein Medical Research Training Center, Shahid Madani St. Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 2597
Email
Omid_medicine@yahoo.com
Web page address
https://ehmc.sbmu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD