Genu Varum, High Tibial Osteotomy, Medial Compartment Osteoarthritis, Varus Deformity
Conditions
Brief summary
This study aims to compare the efficacy, accuracy, and functional outcomes of two different surgical stabilization techniques for medial opening wedge high tibial osteotomy (HTO) in patients with varus deformity and medial compartment osteoarthritis. Patients will be prospectively randomized into two groups: Group 1 (Plate Fixation) will receive acute (single-stage) correction and stabilization with a medial HTO locking plate. Group 2 (HTO External Fixator) will receive stabilization using a self-adjusting HTO external fixator, followed by gradual correction (hemicallotasis/distraction) starting 7 days post-operatively. The study will evaluate radiological correction, functional improvement (using the Oxford Knee Score), and complication rates over a 12-month follow-up period.
Interventions
DEVICEMedial HTO Locking Plate
Medial Opening Wedge High Tibial Osteotomy.
DEVICESelf-Adjusting HTO External Fixator
Medial Opening Wedge High Tibial Osteotomy.
Sponsors
Muhammed Cagatay Engin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Varus malalignment associated with medial compartment degeneration/osteoarthritis. Indication for Medial Opening Wedge HTO. Aged 18 years or older. Willing to participate in the study and provide written informed consent.
Exclusion criteria
* Advanced-stage osteoarthritis (Indication for Total Knee Arthroplasty). Previous open knee surgery on the same extremity. Inability to comply with follow-up appointments. Significant comorbidities (e.g., uncontrolled diabetes, rheumatoid arthritis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Radiological Correction (Hip-Knee-Ankle Angle - HKA) | Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative. | ssessment of the mechanical axis on full-length weight-bearing radiographs (Measured in degrees). |
| Change in Functional Status (Oxford Knee Score - OKS) | Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative. | Patient-reported functional score assessing pain and knee function. |
| Change in Pain Intensity (Visual Analogue Scale - VAS) | Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative | Patient-reported pain score from 0 (no pain) to 10 (intolerable pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patellar Height (Insall-Salvati Index) | Baseline (Preoperative) and 12 Months Postoperative. | Change in patellar height measured by the Insall-Salvati ratio. |
| Change in Femoro-Tibial Angle (FTA) | Baseline (Preoperative) and 12 Months Postoperative. | Change in the anatomical axis measured in degrees. |
| Incidence of Complications | Up to 12 months postoperative. | Incidence of adverse events including pin tract infection (especially Group 2), superficial or deep infection, non-union/delayed union, lateral cortex fracture, hardware exposure, or knee stiffness. |
| Change in Mechanical Axis Percentage (MA%) | Baseline (Preoperative) and 12 Months Postoperative. | Change in the position of the weight-bearing line on the tibial plateau. |
| Change in Posterior Tibial Slope (PTE) | Baseline (Preoperative) and 12 Months Postoperative. | Change in the tibial slope measured in degrees. |
Countries
Turkey (Türkiye)
Contacts
Primary Contactali afşar, md
Outcome results
None listed