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the trial of osteotomies

Comparing Proximal Fibular Osteotomy and High Tibial Osteotomy for Medial Knee Osteoarthritis: A Study Protocol for a Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231212060345N2
Enrollment
60
Registered
2025-07-05
Start date
2025-07-23
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

medial compartment osteoarthritis of the knee. Osteoarthritis of knee

Interventions

Intervention 1: Intervention group: The intervention group includes patients who undergo only a fibula osteotomy, without any osteotomy in the tibia.In this method, first, a longitudinal incision of a

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: Age = 40 years Kellgren–Lawrence grade II or III isolated medial tibiofemoral OA on weight-bearing radiographs Varus alignment = 7° Knee flexion = 90°

Exclusion criteria

Exclusion criteria: Prior knee surgery or fracture Inflammatory or post-traumatic arthritis Radiographic lateral or patellofemoral OA Medial proximal tibial angle (MPTA) 35 kg/m²

Design outcomes

Primary

MeasureTime frame
Change in the pain subscale score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from baseline to 12 months after surgery. This score is a numerical score between 0 and 20 and indicates the severity of patients' pain in daily activities. This variable was selected as the main outcome of the study because it reflects the degree of improvement in patients' pain symptoms, which is the main goal of the surgical intervention. Timepoint: Measurement of the pain score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline (before surgical intervention) and 12 months after the intervention. Method of measurement: Pain severity will be measured using a validated Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire in Persian and self-reported by the patient. The pain score of this questionnaire is a number between zero (no pain) and twenty (very severe pain intensity) and is calculated using the total score of the pain-related questions.

Secondary

MeasureTime frame
Change in physical performance score in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire from the beginning of the study to twelve months after the intervention. This numerical variable is between zero and sixty-eight and indicates the degree of functional disability of patients in performing daily activities. This variable is considered as a secondary outcome to evaluate the effect of surgical intervention on the functional ability of patients. Timepoint: Measurement of physical performance score in the WOMAC questionnaire at the beginning of the study (before surgical intervention), one month, six months and twelve months after the intervention. Method of measurement: Measurement of physical performance of patients will be carried out through a valid Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire in Persian and in a self-reported manner by the patient. The performance score in this questionnaire is a number between zero (no functional problems) and sixty-eight (the highest level of disability).;Change in active knee range of motion (including knee flexion and extension) in degrees, which is considered an objective indicator of improvement in joint function after surgical intervention. This variable is especially important in assessing the impact of surgery on joint flexibility and return to daily activities. Timepoint: Knee range of motion measurement at the beginning of the study (before surgical intervention), one month, six months, and twelve months after the intervention. Method of measurement: Knee flexion and extension angles are measured by a trained physiotherapist using a goniometer. This tool records joint angles with high accuracy and the results are reported numerically in degrees.;The patients' functional and clinical score based on the Knee Society Score, which includes two separate sections to assess the clinical condition of the knee (including pain, range of motion, stab

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Ayati Firouzabadi

Tehran University of Medical Sciences

sinaaghajani1379@gmail.com+98 21 6119 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026