Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application : Multicenter, Comparative, Evaluator-blinded, Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment
研究概览
简要总结
The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent high tibial osteotomy(HTO) were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients participating in the "Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® ; Cartilage Defect Treatment Assisting Cartilage Regeneration in Knee Cartilage Defects : Multicenter, Independent Evaluator and Subject Blinded, Microfracture Comparative, Superiority, Randomized, Confirmatory Clinical Study and 5 Years Follow up Study"
- •Patients who simultaneously underwent HTO during knee joint cartilage surgery
排除标准
- 未提供
结局指标
主要结局
Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment
时间窗: When removing fixtures after HTO (an average of 1 year after surgery)
Primary Endpoint \[experimental group / control group\]
Comparison of macroscopic status of regenerated cartilage
时间窗: When removing fixtures after HTO (an average of 1 year after surgery)
Primary Endpoint \[experimental group / control group\]
次要结局
- Comparison of IKDC score(At last visit (an average of two years after surgery))
- Comparison of Kellgren-Lawrence grade(At last visit (an average of two years after surgery))
- Comparison of KOOS score(At last visit (an average of two years after surgery))
- Comparison of HKA angle, Posterior Tibial slope(At last visit (an average of two years after surgery))
- Comparison of VAS score(At last visit (an average of two years after surgery))
- Comparison of WOMAC score(At last visit (an average of two years after surgery))