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IRCT20200305046700N6 IRCT 2025-05-03 Tehran University of Medical Sciences Lateral screw in high tibial osteotomy Evaluating the efficacy and side effects of using lateral screw in high tibial osteotomy 2025-05-20 anticipated 50 Complete https://irct.ir/trial/78865 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization (balanced blocks), Blinding description: Double-blind — the patient and outcome assessor are blinded. The surgeon is aware of the allocation. N/A knee osteoarthritis. Intervention 1: Intervention group: HTO with screw. Intervention 2: Control group: HTO without screw. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mohammadreza Razzaghof
No.17, Sheybani Alley, North Jamalzadeh Street
Tehran Iran (Islamic Republic of) 1416753955 +98 21 6658 0196 m-razzaghof@razi.tums.ac.ir Tehran University of Medical Sciences scientific Mohammadreza Razzaghof
No.17, Sheybani Alley, North Jamalzadeh Street
Tehran Iran (Islamic Republic of) 1416753955 +98 21 6658 0196 m-razzaghof@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age >18 and <50 Varus knee with or without medial osteoarthritis (Kellgren-Lawrence grade 3–4) Informed consent MPTA ≤ 83 18 years 50 years Both Previous limb surgery Inflammatory arthritis Range of motion < 90° Severe varus >15°, flexion contracture >15°, or tibial subluxation >1 cm Severe medial tibial bone loss (>3 mm) M17 Osteoarthritis of knee Treatment - Surgery Treatment - Surgery Intervention group: HTO with screw Control group: HTO without screw Improvement in knee function and pain based on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Timepoint: WOMAC score will be assessed at baseline (preoperative), 6 months after surgery. Method of measurement: The Persian-validated version of the WOMAC questionnaire will be used. The questionnaire will be self-reported by the patient under supervision of the research team. Pain level during activity using Visual Analog Scale (VAS). Timepoint: Preoperative, 6 weeks, 12 weeks, 6 months, and 1 year after surgery. Method of measurement: VAS questionnaire (0–10 scale), patient-reported. Radiographic union of the osteotomy site after high tibial osteotomy (HTO). Timepoint: 6 weeks, 8 weeks, 10 weeks, 12 weeks, 6 months, and 1 year. Method of measurement: Radiographic assessment by orthopedic surgeon. Union is confirmed when 3 out of 4 cortices are bridged on standard AP and lateral X-rays and the patient reports minimal or no pain during full weight-bearing (VAS ≤ 2). Time (in weeks) to return to work and athletic activity. Timepoint: Recorded once achieved during follow-up. Method of measurement: Patient interview during follow-up visits. Radiological Angles (MPTA, LDFA, PTS, Varus Angle). Timepoint: Preoperative and last follow-up (6 months or 1 year). Method of measurement: Radiographic measurement on full-length standing X-rays. Tehran Univeristy Approved 2024-05-07 Ethics committee of Imam khomeini hospital complex Keshavarz boulevard, Imam khomeini hospital complex Tehran Tehran Iran (Islamic Republic of)