Investigation and comparison of the results of correction of knee varus deformity with medial open wedge and lateral closed wedge in patients with symptomatic genu varum
Investigation and comparison of the results of correction of knee varus deformity with medial open wedge and lateral closed wedge
Design
In this study, sample size is 76 and no blinding is done. A random number is selected from the random numbers table and placed in sealed envelopes
Settings and conduct
This clinical trial study will investigate and compare two methods of varus deformity correction. Considering the sample size qualified patients are introduced to Ghaem and Mehr hospitals of Mashhad, after informed consent, based on the random numbers table and the prepared envelope, an envelope is opened and the patient is assigned to one of the surgery groups. Before surgery, a checklist including patient's demographic information and life quality and satisfaction questionnaire, as well as radiology information for each patient will be completed. After surgery, the patient will be evaluated in terms of short-term and long-term outcomes as well as complications of the surgery and changes related to patient's satisfaction are assessed at intervals of 6 weeks, 3 months, 6 months and one year
Participants/Inclusion and exclusion criteria
Inclusion criteria :having significant pain and disability due to osteoarthritis; varus deformity; patient's ability to use crutch after operation; good vascular status.
Exclusion criteria: history of internal disease; history of fracture in the lower extremity; history of surgery in the knee joint; lower limb muscular lesion; heart failure and varicosis
Intervention groups
Intervention group one: Deformity treatment of the knee with medial open wedge method
Intervention group two: Deformity treatment of the knee with lateral closed wedge method
Main outcome variables
Pain measurement using VAS; investigation of knee Injury and osteoarthritis outcome score (KOOS); range of motion and stability of medial and lateral ligaments.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180408039241N1
Registration date:2019-01-20, 1397/10/30
Registration timing:registered_while_recruiting
Last update:2019-01-20, 1397/10/30
Update count:0
Registration date
2019-01-20, 1397/10/30
Registrant information
Name
Hadi Makhmalbaf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2610
Email address
makhmalbafh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-26, 1397/07/04
Expected recruitment end date
2019-12-25, 1398/10/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation and comparison of the results of correction of knee varus deformity with medial open wedge and lateral closed wedge in patients with symptomatic genu varum
Public title
Investigation of the results of correction of knee varus deformity with two surgical methods in patients with bow legs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having significant pain and disability in respect to osteoarthritis
Varus deformity
Patient's ability to use crutch after operation
Good vascular status
Exclusion criteria:
History of internal disease
History of fracture in the lower extremity
History of surgery in the knee joint
Having muscular lesion in the lower extremity
Heart failure and varicosis
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups. For each group, 38 random numbers are selected from random numbers table and placed in sealed envelopes. Envelopes are given to a specific person, and when a patient refers for surgery, an envelope is opened and based on it, the patient is placed in a specific 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 Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2018-05-30, 1397/03/09
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.451
Health conditions studied
1
Description of health condition studied
Genuvarum
ICD-10 code
M21.1
ICD-10 code description
Varus deformity, not elsewhere classified
Primary outcomes
1
Description
Measuring the amount of pain
Timepoint
Before surgery and 6 months and one year after surgery
Method of measurement
Using the pain rate questionnaire (Visual Analogue Scale)
2
Description
Knee injuries
Timepoint
Before surgery and 6 months and one year after surgery
Method of measurement
Using a simple graph of knee and questionnaire of knee Injury and osteoarthritis outcome score (KOOS)
3
Description
Knee joint range of motion
Timepoint
before surgery and at intervals of 2 weeks, 6 weeks, 3 months, 6 months and one year after surgery
Method of measurement
Clinical examinations
4
Description
Stability of medial and lateral ligaments
Timepoint
2 weeks, 6 weeks, 3 months, 6 months and one year after surgery
Method of measurement
Clinical examinations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, patients are treated with medial opening wedge osteotomy. Under sterile condition and general anesthesia, incision of medial proximal tibia is carried out and the proximal tibia becomes exposed. Afterwards, on the tibial tuberosity surface, medial proximal osteotomy is carried out and a wedge with appropriate size is placed in location of osteotomy and is fixed using proximal tibia t-plate, 3 proximal and 3 distal screws. Then, drain placement will be done
Category
Treatment - Surgery
2
Description
Intervention group 2: In this group, patients are treated by lateral closing wedge osteotomy. Under sterile condition and general anesthesia, incision of lateral and proximal tibia is performed. Osteotomy of the head of fibula is carried out while maintaining peroneal nerve. Afterwards, corticotomy of interior tibia with maintaining patellar tendon , corticotomy of medial tibia with maintaining MCL (medial collateral ligament), lateral corticotomy with maintaining LCL (lateral collateral ligament) and posterior corticotomy with maintaining popliteal artery are carried out. Lateral wedge correction is performed using 2 genu varum staples.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Ali Dastjerdi
Street address
Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2610
Email
Alidastjerdi555@gmail.com
2
Recruitment center
Name of recruitment center
Mehr Hospital
Full name of responsible person
Ali Dastjerdi
Street address
Alandasht Square, Kohsangi Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3842 7011
Email
Alidastjerdi555@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
960409
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ali Dastjerdi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801
Email
Alidastjerdi555@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hadi Makhmalbaf
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801
Email
makhmalbafh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hadi Makhmalbaf
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Ghaem hospital, Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801
Email
makhmalbafh@mums.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.