Long-term Clinical and Radiographic Outcomes of Different Knee Osteotomy Techniques for the Treatment of Compartmental Knee Osteoarthritis With Lower Limb Malalignment.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Lysholm Knee Score
研究概览
简要总结
The present study aims to evaluate the long-term and medium-term outcomes of different knee osteotomy techniques in the treatment of knee osteoarthritis in patients with lower limb malalignment. This evaluation is necessary in the current context of research on the treatment and prevention of knee osteoarthritis through treatments that do not involve or allow for the postponement of prosthetic replacement. Among the biological treatments performed in orthopedic clinical practice, osteotomy is one of the most promising. However, further long-term evaluations are needed to more clearly determine the indications and potential of this type of intervention, considering the various surgical procedures described for performing it.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing corrective knee osteotomy and any associated procedures such as meniscal repair/resection/replacement, ligament reconstruction, chondral treatment, or regenerative infiltrative treatment;
- •Patients aged between 18 and 70 years at the time of surgical intervention;
- •Patients with isolated compartmental osteoarthritis;
- •Patients with a varus or valgus knee alignment defect of at least 3° compared to mechanical neutrality.
排除标准
- •Patients with advanced multicompartimental osteoarthritis;
- •Patients who are no longer reachable;
- •Women of childbearing age who cannot exclude pregnancy;
- •Patients unable to give informed consent or patients unwilling to sign the informed consent form.
研究组 & 干预措施
Closing wedge
Patients undergoing closing wedge high tibial osteotomy in knee ostheoarthritis and lower limb malalignement
干预措施: High tibial osteotomy (Other)
Opening wedge
Patients undergoing opening wedge high tibial osteotomy in knee ostheoarthritis and lower limb malalignement
干预措施: High tibial osteotomy (Other)
结局指标
主要结局
Lysholm Knee Score
时间窗: 24 months after surgery
It is a validated measurement scale that assesses knee functionality through 8 items, which help determine the condition of the knee in response to the functional demands of daily activities. This evaluation form is commonly used to assess the outcomes of surgery in patients who have undergone operations for ligament or meniscal injuries of the knee. The final score is obtained by summing the various scores from the different items and ranges from 0 to 100. The scores are divided into subgroups: Excellent (95-100); Good (84-94); Fair (65-83); Poor (\<64).
次要结局
- Complications or subsequent interventions(24 months after surgery)
- Objective IKDC(IKDC standard evaluation form)(24 months after surgery)
- Hip circonference(24 months after surgery)
- Patient satisfaction(24 months after surgery)
- Tegner Score(24 months after surgery)
- SF-36 (Short Form-36 Health Survey)(24 months after surgery)
- International Knee Documentation Committee (IKDC)(24 months after surgery)
- VAS (visual analog scale)(24 months after surgery)
- Anterior knee pain / pain during knee flexion(24 months after surgery)
- Radiographic evaluation(24 months after surgery)
研究者
Stefano Zaffagnini
Full Professor Medicine and Surgery, University of Bologna
Istituto Ortopedico Rizzoli