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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Plate Fixation | Experimental | The osteotomy will be acutely corrected intraoperatively and stabilized using a Medial High Tibial locking plate. |
|
| Group 2: HTO External Fixator | Active Comparator | he osteotomy will be stabilized using a Self-Adjusting HTO External Fixator. Gradual distraction (hemicallotasis) will begin 7 days post-operatively at a rate of 1 mm per day to achieve correction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medial HTO Locking Plate | Device | Medial Opening Wedge High Tibial Osteotomy. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Radiological Correction (Hip-Knee-Ankle Angle - HKA) | ssessment of the mechanical axis on full-length weight-bearing radiographs (Measured in degrees). | Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative. |
| Change in Functional Status (Oxford Knee Score - OKS) | Patient-reported functional score assessing pain and knee function. | Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative. |
| Change in Pain Intensity (Visual Analogue Scale - VAS) | Patient-reported pain score from 0 (no pain) to 10 (intolerable pain). | Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Femoro-Tibial Angle (FTA) | Change in the anatomical axis measured in degrees. | Baseline (Preoperative) and 12 Months Postoperative. |
| Change in Mechanical Axis Percentage (MA%) | Change in the position of the weight-bearing line on the tibial plateau. |
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Inclusion Criteria:
Indication for Medial Opening Wedge HTO. Aged 18 years or older. Willing to participate in the study and provide written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ali afşar, md | Contact | +905374927543 | afsarali1708@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ataturk University, Department of Orthopedics and Traumatology | Erzurum | Erzurum | 25240 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D056305 | Genu Varum |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Self-Adjusting HTO External Fixator |
| Device |
Medial Opening Wedge High Tibial Osteotomy. |
|
| Baseline (Preoperative) and 12 Months Postoperative. |
| Change in Posterior Tibial Slope (PTE) | Change in the tibial slope measured in degrees. | Baseline (Preoperative) and 12 Months Postoperative. |
| Change in Patellar Height (Insall-Salvati Index) | Change in patellar height measured by the Insall-Salvati ratio. | Baseline (Preoperative) and 12 Months Postoperative. |
| Incidence of Complications | 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. | Up to 12 months postoperative. |