NCT04905394已完成不适用
Short Term Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain reduction
研究概览
简要总结
Bone marrow lesions (BMLs) of the knee are common subchondral defects, often associated with pain and functional limitation. Subchondroplasty is a percutaneous procedure in which calcium phosphate is injected inside BML areas, ensuring stability and promoting the deposition of new bone. Primary outcome of this study was to obtain a reduction of the Numeric Rating Scale score of 4 points or more at 6 months follow-up in more than 75% of patients. The secondary outcome was to evaluate the osteoarthritic and bone marrow structure evolution in the months after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Atraumatic knee pain for at least 3 months;
- •Failure of conservative treatment (including NSAIDs, physical therapy, intra- articular injection with steroids or hyaluronic acid and bisphosphonates);
- •Mild to moderate osteoarthritis (Kellgren-Lawrence18 grade ≤ 3)
- •BML on a loading area at MRI imaging (femoral condyles and/or tibial plateau)
排除标准
- •Knee pain and functional limitation related to other causes like osteonecrosis
- •Fractures or inflammatory arthritis
- •Ligamentous instabilities
- •Malalignment on the coronal axis greater than 10 degrees in varus/valgus
- •Severe tri-compartmental arthritis (Kellgren-Lawrence grade 4)
结局指标
主要结局
Pain reduction
时间窗: 6 months
Pain reduction of 4 points in numeric rating score
次要结局
- Radiological evaluation(6 months)
研究者
Pietro Randelli, MD
Professor
University of Milan
研究点 (2)
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