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IRCT20211208053330N1 IRCT 2023-10-01 Hamedan University of Medical Sciences Comparsion of uniplan versus bipaln distal femur osteotomy with or whitout bone graft Comparsion of uniplan versus bipaln distal femur osteotomy with or whitout bone graft 2021-05-05 anticipated 68 Complete https://irct.ir/trial/67561 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Genu Valgum. Intervention 1: 1st Intervention group: Distal femur osteotomy biplan with bone graft. Intervention 2: 2nd Intervention group: Distal femur osteotomy uniplan with bone graft (bone chips). Intervention 3: Control group: Distal femur osteotomy biplan or uniplan with out bone graft (bone chips). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Data analysis is not complete
public Sadegh Abedi
Hokama
Hamedan Iran (Islamic Republic of) 5265478951 +98 81 3434 6598 drp.abedi@gamil.com Hamedan University of Medical Sciences scientific Sadegh Abedi
Hokema
Hamedan Iran (Islamic Republic of) 3265458769 +98 990 173 7302 drp.abedi@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) 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 18 years 45 years Both History of distal femur fracture History of skin diseases such as psoriasis History of systemic and genetic diseases related to bone deformity Treatment - Surgery Treatment - Surgery N/A 1st Intervention group: Distal femur osteotomy biplan with bone graft 2nd Intervention group: Distal femur osteotomy uniplan with bone graft (bone chips) Control group: Distal femur osteotomy biplan or uniplan with out bone graft (bone chips) Union time. Timepoint: 3 months - 6 months - 1 year. Method of measurement: Complete union in control X-ray. KSS sore. Timepoint: 1 year. Method of measurement: Knee Society Score. Surgical satisfaction (SSQ-8). Timepoint: 12 month. Method of measurement: surgical satisfaction Questionnaire (SSQ-8). Knee valgus degree. Timepoint: before intervention and 3month after surgery. Method of measurement: mLDFA (mechanichal latral distal femoral angle) lower limb 3 joint X-ray. gholamreza ghorbani Approved 2023-05-03 Ethics committee of Hamedan University of Medical Sciences Education unit, Besat hospital, Motahari Ave, Hokama Blvd, Hamedan Hamedan Hamadan Iran (Islamic Republic of)