Medial Opening Wedge High Tibial Osteotomy: A Comparative Study of Plate Fixation and Self-Adjusting HTO External Fixator Techniques
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity (Visual Analogue Scale - VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Group 1: Plate Fixation
The osteotomy will be acutely corrected intraoperatively and stabilized using a Medial High Tibial locking plate.
干预措施: Medial HTO Locking Plate (Device)
Group 2: HTO External Fixator
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.
干预措施: Self-Adjusting HTO External Fixator (Device)
结局指标
主要结局
Change in Pain Intensity (Visual Analogue Scale - VAS)
时间窗: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative
Patient-reported pain score from 0 (no pain) to 10 (intolerable pain).
Change in Functional Status (Oxford Knee Score - OKS)
时间窗: Baseline (Preoperative), 6 Weeks, 3 Months, 6 Months, and 12 Months Postoperative.
Patient-reported functional score assessing pain and knee function.
Change in Radiological Correction (Hip-Knee-Ankle Angle - HKA)
时间窗: 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).
次要结局
- Change in Femoro-Tibial Angle (FTA)(Baseline (Preoperative) and 12 Months Postoperative.)
- Change in Mechanical Axis Percentage (MA%)(Baseline (Preoperative) and 12 Months Postoperative.)
- Change in Posterior Tibial Slope (PTE)(Baseline (Preoperative) and 12 Months Postoperative.)
- Change in Patellar Height (Insall-Salvati Index)(Baseline (Preoperative) and 12 Months Postoperative.)
- Incidence of Complications(Up to 12 months postoperative.)
研究者
Muhammed Cagatay Engin
Associate Professor
Ataturk University