NCT00793104终止3 期
Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Focal Cartilage Lesions in the Femoral Condyle
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- RTI Surgical
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months
研究概览
简要总结
Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee
详细描述
The specific aim in this study is to assess the ability of the CR-Plug to treat osteochondral focal defects of less than 2.5 cm squared at high-load-bearing femoral condyle.
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
- •18 years of age or older
- •Skeletally mature
- •Have one symptomatic score International Cartilage Repair Score (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle (MFC) or Lateral Femoral Condyle (LFC). Symptoms must include pain, pain with weight bearing and squatting, locking of joints, and/or swelling
- •Functional meniscal tissue (defined as 5 mm or more width)
- •A score of = or greater than 4 on the VAS questionnaire
排除标准
- •Associated tibial or patellar articular cartilage defect greater than 2 ICRS
- •Osteoarthritis of either knee
- •Mechanical axis malalignment of greater than 5 degrees
- •Patellofemoral incongruity of Merchant view
- •One or more multiple defects greater than 2.5 cm
- •Osteochondritis dissecans (OCD) with depth of bone loss greater than 4 mm
- •Ligament treatments in the affected knee within one yer prior to current study
- •Previous surgical meniscus treatments in the affected knee in the last 6 months
- •Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment
- •Use of any investigational therapy with in 30 days prior to the first visit
- •Corticosteroid or viscosupplementation within the past 3 months
- •A score of 3 or less on the VAS Questionnaire
- •Active gout or pseudogout or systemic inflammatory condition
结局指标
主要结局
The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months
时间窗: 24 months
The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). 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
- Lysholm With Tegner Score(24 months)
- International Knee Documentation Committee (IKDC) at 24 Months.(24 months)
- MRI Evaluation Score(24 months)
- Current Health Assessment(24 months, MRI only at 12 and 24 months)
研究者
研究点 (6)
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