To evaluate the efficacy and complications of using a lateral screw in patients undergoing high tibial osteotomy (HTO).
Design
Double-blind randomized controlled trial (RCT) using permuted block randomization.
Settings and conduct
Conducted at Imam Khomeini Hospital Complex, Tehran. Eligible patients will be enrolled over a 6-month period in 2024. All procedures will be standardized, and follow-ups will be conducted at regular intervals postoperatively.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Age over 18 and under 50 years
Knee varus deformity with or without medial compartment osteoarthritis (Kellgren-Lawrence grade 3 or 4)
Informed consent
MPTA (Medial Proximal Tibial Angle) less than or equal to 83 degrees
Exclusion Criteria
History of previous surgery on the limb
Revision surgery
Dementia or psychiatric disorders
Inflammatory arthritis
Use of systemic corticosteroids
Uncontrolled diabetes
Range of motion less than 90 degrees
Varus deformity greater than 15 degrees, flexion contracture greater than 15 degrees, or subluxation greater than 1 cm
Severe bone defect in the medial tibia
Skin problems at the surgical site
Smoking within the past three months
Use of NSAIDs up to 6 weeks before surgery
Vascular diseases
BMI greater than 30 or less than 18
Intervention groups
Group A (Intervention): HTO with insertion of a 6.5 mm partially threaded lateral screw
Group B (Control): HTO without lateral screw
Main outcome variables
Time to radiographic union
Pain (VAS score)
Knee function (WOMAC, IKDC, Lysholm)
Postoperative complications (infection, wound issues, osteomyelitis, non-union)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200305046700N6
Registration date:2025-05-03, 1404/02/13
Registration timing:prospective
Last update:2025-05-03, 1404/02/13
Update count:0
Registration date
2025-05-03, 1404/02/13
Registrant information
Name
Mohammadreza Razzaghof
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 0196
Email address
m-razzaghof@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-20, 1404/02/30
Expected recruitment end date
2025-10-22, 1404/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy and side effects of using lateral screw in high tibial osteotomy
Public title
Lateral screw in high tibial osteotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age >18 and <50
Varus knee with or without medial osteoarthritis (Kellgren-Lawrence grade 3–4)
Informed consent
MPTA ≤ 83
Exclusion criteria:
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)
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization (balanced blocks)
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind — the patient and outcome assessor are blinded. The surgeon is aware of the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Imam khomeini hospital complex
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.
Secondary outcomes
1
Description
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
2
Description
Radiographic union of the osteotomy site after high tibial osteotomy (HTO).
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).
3
Description
Time (in weeks) to return to work and athletic activity