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Comparison of uniplanar and biplanar ostotomy in varus knee deformity and its impact

Comparison of uniplanar and biplanar proximal tibial ostotomy (HTO) in genuvarus knee deformity and its impact on clinical outcomes of patients: A randomized, double-blind clinical trial study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240425061571N3
Enrollment
92
Registered
2025-03-13
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis. Osteoarthritis, unspecified site

Interventions

Intervention 1: Intervention group: Intervention group: Osteotomy technique: A 6 to 8 cm longitudinal skin incision was made in the anteromedial and proximal tibia from the infrapatella to the distal.

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 60 Years

Inclusion criteria

Inclusion criteria: Age under 60 years Definitive diagnosis of medial osteoarthritis of the knee joint surface, as diagnosed by an orthopedic physician, according to the Kellgren and Lawrence osteoarthritis classification system, grade 3 and above (moderate and severe) Knee pain and disability due to osteoarthritis that significantly interferes with employment or active recreation Failure to respond to non-invasive treatments such as physical therapy and medication for 3 months

Exclusion criteria

Exclusion criteria: Narrowing of the lateral compartment cartilage space Lateral tibial subluxation of more than 1 cm Loss of bone in the inner side of the tibia of more than 2 or 3 mm Flexion contracture greater than 15 degrees Knee bending less than 90 degrees More than 20 degrees of correction required Inflammatory arthritis Significant peripheral vascular disease Pregnancy Opioid addiction Diabetes

Design outcomes

Primary

MeasureTime frame
Knee Injury and Osteoarthritis Outcome Score (KOOS). Timepoint: The primary outcome assessment will be performed 3 times (at the beginning of the study, after surgery, after 6 months of surgery). Method of measurement: Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire.;Joint line convergence angle. Timepoint: The primary outcome assessment will be performed 3 times (at the beginning of the study, after surgery, after 6 months of surgery). Method of measurement: Using Marco Pacs software.;Posterior tibial slope angle medial. Timepoint: The primary outcome assessment will be performed 3 times (at the beginning of the study, after surgery, after 6 months of surgery). Method of measurement: Using Marco Pacs software.;Posterior tibial slope angle lateral. Timepoint: The primary outcome assessment will be performed 3 times (at the beginning of the study, after surgery, after 6 months of surgery). Method of measurement: Using Marco Pacs software.

Secondary

MeasureTime frame
Blackburne-Peel ratio. Timepoint: Before intervention and 24 weeks after intervention. Method of measurement: Using marco pacs software.;Hip-knee-ankle (HKA) angle. Timepoint: Before intervention and 12 and 24 weeks after intervention. Method of measurement: three joint view x ray.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactYasin Sharifzadeh

Babol University of Medical Sciences

dryasinsharifzadeh@gmail.com+98 11 3225 2071

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026