Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Osteochondral Defects in High-Load-Bearing Region and Low-Load-Bearing Region of the Femoral Condyle
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- RTI Surgical
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS
研究概览
简要总结
The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment of smaller, focal defects (like the injury the patient has to their knee).
详细描述
The main objective of this double arm study is to test the ability of an allograft plug to provide "successful" repair of less than (<) 2.5 cm2 osteochondral defect in a low-load-bearing femoral condyle region, and a high-load-bearing femoral-condyle region.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 55 years
- •skeletally mature
- •Have a symptomatic score International Cartilage Repair Society (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle or Lateral Femoral Condyle. Symptoms must include pain, pain with weight bearing and squatting, locking of joints and or swelling
- •Functional meniscal tissue (defined as 5 mmor greater)
- •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 on 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 year prior to current study
- •Previous surgical meniscus treatment 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 within 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
- •Microfracture less than one year prior to current study
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS
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
- Magnetic Resonance Imaging (MRI) Results(24 months)
- Current Health Assessment (CHA)(24 months)
- IKDC Assessment(24 months)
- Lysholm Score at 24 Months(24 months)