NCT03262909Unknown不适用
A Prospective, Open-Label, Multicenter Pivotal Study to Evaluate the Safety and Efficacy of GelrinC® for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle: A Comparison to Historical Control Microfracture
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 181
- 试验地点
- 13
- 主要终点
- The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
研究概览
简要总结
Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a historical control arm (microfracture) in the treatment of cartilage defects in the knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Age between 18 and
- •Single contained symptomatic lesion located on the femoral condyle of the femur graded as ICRS III or IV with less than 5 mm of bone loss below the subchondral plate.
- •Lesion size between 1 and 5 cm2 post debridement, less than or equal to 2.5 cm in diameter.
- •Contralateral knee is asymptomatic, stable, fully functional and not medically treated.
排除标准
- •Presence of an additional grade III or IV symptomatic lesion.
- •Recent Osteochondritis Dissecans within 1 year of baseline visit.
- •Untreated ACL and/or PCL deficiency or Complex ligamentous instability of the knee.
- •Patient is excluded if presenting untreated current meniscal tear or if previous menisci resection was within the last 6 months.
- •Previous tendon repair or ligament reconstruction within the last 6 months.
- •Failed Mosaicplasty or ACI or MACI or any other cartilage repair product.
- •Microfracture performed less than 1 year before baseline visit.
研究组 & 干预措施
GelrinC prospective treatment arm
Experimental
Patients will undergo GelrinC implantation.
干预措施: GelrinC (Device)
Microfracture historical control arm
Other
Microfracture historical control arm
干预措施: Microfracture historical control arm (Other)
结局指标
主要结局
The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
时间窗: 24 months post-surgery
The change of physical pain as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
时间窗: 24 months post-surgery
次要结局
未报告次要终点
研究者
研究点 (13)
Loading locations...
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