Retro Versus Trans Articular Drilling for Juvenile Osteochondritis Dissecans of the Knee: A Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 27
- 主要终点
- Physical functioning measured by the Pedi-IKDC (International Knee Documentation Committee) total score
研究概览
简要总结
The purpose of this study is to compare the functional, clinical and radiographic outcomes associated with trans-articular drilling versus retro-articular drilling, two commonly employed techniques of operative treatment for stable forms of juvenile osteochondritis dissecans (JOCD) lesions. This study also aims to better define the natural history of this condition in its most commonly identified pathological state (as a stable lesion) following surgical intervention by determining the rate of radiographic healing and any need for secondary surgery.
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
- Single (Participant)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of JOCD,
- •Lesion located on the lateral aspect of the medial femoral condyle,
- •Lesion considered stable based on MRI,
- •Patient deemed skeletally immature based on MRI,
- •Completed a course of conservative therapy.
排除标准
- •Significant concomitant knee pathology (AVN, fracture, inflammatory arthritis, ACL tear, discoid/meniscal tear, etc.)
- •Lesion healed sufficiently and surgery is not recommended,
- •Prior surgery on the affected knee,
- •Diagnosis of metabolic bone disorder (e.g. osteogenesis imperfecta),
- •Diagnosis of sickle cell disease,
- •History of prolonged corticosteroid or chemotherapy treatment,
结局指标
主要结局
Physical functioning measured by the Pedi-IKDC (International Knee Documentation Committee) total score
时间窗: One year post-surgery
次要结局
- Activity level as measured by the Marx Activity Scale(One year post-surgery)
- Time to lesion healing(3 months to 2 years post-surgery)
- Physical functioning as measured by the Pedi-IKDC total score(Two years post-surgery)
研究者
Benton Heyworth
Instructor in Orthopaedic Surgery
Boston Children's Hospital