Effects of Unloader Bracing in Clinical Outcome and Articular Cartilage Physiology Following Microfracture of Isolated Chondral Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
研究概览
简要总结
The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.
The surgery performed will be the same for all patients
The length of follow up and schedule of post-operative MRI will be the same for all patients.
The only difference in groups will be presence of absence of brace wear.
详细描述
The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Radiographic outcome will be assessed via MRI scans post-operatively. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.
The surgery performed will be the same for all patients
The length of follow up and schedule of post-operative MRI will be the same for all patients.
The only difference in groups will be presence of absence of brace wear.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •isolated chondral defect of medial or lateral femoral condyle 2cm squared or less
- •age 15-40
- •neutral knee alignment
排除标准
- •prior cartilage procedures performed in the same knee
- •other significant knee pathology including meniscus tears, ligament tears or inflammatory arthritis
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
时间窗: 2 years
KOOS is a validated outcome score that evaluates knee symptoms, knee pain, knee use in activities of daily living, function in sport and recreation and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
次要结局
- Change From Baseline in Cartilage Thickness (Radiographic Outcome)(2 years)
- Change From Baseline in Tegner Score (Clinical Outcome)(2 years)
- Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)(2 years)
- Change From Baseline in T2 Relaxation Time (Radiographic Outcome)(2 years)
- Change From Baseline in Lysholm Score (Clinical Outcome)(2 years)
- Change From Baseline in Cartilage Volume (Radiographic Outcome)(2 years)
研究者
Jason L. Dragoo
Associate Professor of Orthopaedic Surgery
Stanford University