Comparison of biplane and uniplane methods in distal femur osteotomy
Design
A randomized clinical trial, by lottery method (selection from pre-prepared sealed envelopes), with four parallel groups, sample size 68 patients, one-sided blind (patients).
Settings and conduct
Ba'ath Hospital and Bu Ali Hospital, Hamedan
Participants/Inclusion and exclusion criteria
Inclusion criteria: People between 18 and 45 years old, with valgus deformity, valgus angle more than 12 degrees, with pain, the slope of the articular surface is more than 10 degrees from the horizon, low space of joint surface in lateral or medial knee.
Exclusion criteria: History of distal femur fracture, history of skin diseases such as psoriasis, history of systemic and genetic diseases related to bone deformity.
Intervention groups
1- Distal femur osteotomy by biplane method with bone graft
2- Distal femur osteotomy by monoplane method with bone graft
3- Distal femur osteotomy by (biplane or monoplane method ) without bone graft
Main outcome variables
Union time; patients' knee functional score using KSS questionnaire; satisfaction rate using SSQ-8 questionnaire; valgus angle using mLDFA measurement.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211208053330N1
Registration date:2023-10-01, 1402/07/09
Registration timing:retrospective
Last update:2023-10-01, 1402/07/09
Update count:0
Registration date
2023-10-01, 1402/07/09
Registrant information
Name
Sadegh Abedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3377 3294
Email address
drp.abedi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
2021-05-05, 1400/02/15
Actual recruitment end date
2022-08-23, 1401/06/01
Trial completion date
2023-08-23, 1402/06/01
Scientific title
Comparsion of uniplan versus bipaln distal femur osteotomy with or whitout bone graft
Public title
Comparsion of uniplan versus bipaln distal femur osteotomy with or whitout bone graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Varus or valgus angle more than 12 degrees with pain
The slope of the articular surface is more than 10 degrees from the horizon
low space of the joint surface in the lateral or medial knee
Exclusion criteria:
History of distal femur fracture
History of skin diseases such as psoriasis
History of systemic and genetic diseases related to bone deformity
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
68
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple way with an individual unit, and using a sealed envelope that has already been poured into the basket in equal numbers. Patients are unaware of the treatment method. But the surgeon knows the procedure. But after that, the information is recorded in the form of code and the person analyzing the information does not know the type of methods
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants will not know about the surgery procedure. Because the methods in radiology are the same, and the cost and equipment used or the type of surgical incision are the same. Your information is recorded as a code and the analyzer will analyze only 4 groups without specific names.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Education unit, Besat hospital, Motahari Ave, Hokama Blvd, Hamedan