The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction With Bone-Patellar Tendon Bone Autograft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Score on Kujala Anterior Knee Pain Scale (AKPS)
研究概览
简要总结
One of the common complaints after ACLR with BPTB autograft anterior knee pain. It is thought that this may be due to harvesting the patellar tendon for graft use. Specifically, this may be due to the bone defect that is left after graft harvesting. There is currently no consensus on a gold standard for treating the bone defect with surgeons using multiple commercially available bone void fillers as well as autologous bone graft in standard practice.
The purpose of the proposed study is to evaluate the effect bone-void filler on anterior knee pain following ACL reconstruction BPTB autograft.
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
- 是
入选标准
- •Patients undergoing ACLR with BPTB autograft
- •Skeletally mature (as defined by closed growth plates on plain radiograph)
- •At least 18 years of age
- •Willing and able to provide consent
排除标准
- •knee with intact ACL
- •skeletally immature (as defined by open physis on plain radiograph)
- •less than 18 years of age
- •previous ACL repair or reconstruction
- •unable to speak english or perform informed consent
- •multiligamentous knee injury (two or more ligaments requiring surgical attention)
- •varus or valgus malalignment greater than 3 degrees
结局指标
主要结局
Score on Kujala Anterior Knee Pain Scale (AKPS)
时间窗: Month 12 Post-Op
The Kujala AKPS is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. The total score is the sum of responses; total scores range from 0 to 100. Lower scores indicate greater signs of knee pain.
Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey
时间窗: Month 12 Post-Op
The KOOS survery comprises 42 questions; questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), quality of life (4 questions). Each item is rated on a Likert scale from 0 to 4. The score is calculated by summing the responses. The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain / higher difficulty in function.
Change in VAS Score for Anterior Knee Pain
时间窗: Baseline, Month 12 Post-Op
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The total score range is 0-100; the higher the score, the worse the pain.
次要结局
未报告次要终点