A Phase 3, Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART 3D Compared Ot Microfracture in the Treatment of Articular Cartilage Defects
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 233
- 试验地点
- 35
- 主要终点
- Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain
研究概览
简要总结
This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.
详细描述
Subjects with articular knee defects will be randomized to receive either Microfracture or NOVOCART 3D. Subjects will be followed for five years in total and will be evaluated for safety and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 18 years old
- •Isolated articular cartilage lesions on the femoral condyle 2-6 cm2
- •Minimum score on the KOOS questionnaire
排除标准
- •Instability of the knee joint
- •Arthritis
- •Autoimmune disease
- •Immune suppression
- •Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline)
- •Bone disease
- •Any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.
研究组 & 干预措施
NOVOCART 3D
Scaffold assisted autologous chondrocyte Implant
干预措施: NOVOCART 3D (Biological)
Microfracture
considered a typical treatment for articular cartilage repair
干预措施: Microfracture (Procedure)
结局指标
主要结局
Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain
时间窗: 24 months post treatment
As measured by a change in KOOS (pain subdomain) score at 24 months from baseline
Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain
时间窗: 24 months post treatment
As measured by a change in KOOS score (activity of daily living subdomain) at 24 months from baseline
次要结局
未报告次要终点