A Clinical Trial to Evaluate the Efficacy and Safety of Cartilage Regeneration in the Use of MegaCarti® in Patients With Knee Joint Cartilage Injury: Multicenter, Independent Evaluator-subject Blinded, Microfracture-comparative, Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 7
- 主要终点
- MOCART score
研究概览
简要总结
Subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and MegaCarti® will be applied.
详细描述
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.
To evaluate cartilage regeneration, the study group is compared with the microfracture group alone through MOCART evaluation at 48 weeks after treatment for cartilage regeneration. In addition, a biopsy is performed to evaluate the formation of hyaline cartilage and the area ratio of regenerated cartilage is measured.
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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years to 65 years
- •After receiving a detailed explanation of this clinical trial and fully understanding it, the subject or legal representative voluntarily decides to participate in the clinical trial and sign the consent form
- •Subjects with localized full-thickness cartilage defects in the knee joint, International Cartilage Repair Society(ICRS) Grade III or IV
- •Subjects whose primary lesion site can be designated as one section of the knee joint, and the area can be determined as the main cause of clinical symptoms
- •knee cartilage defect size :1.5cm^2 to 10cm^2
排除标准
- •Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
- •When screening, Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (However, arthroscopy for diagnostic purposes is possible. Additionally, it is possible if hightibial osteotomy (HTO) has been performed in advance or is scheduled)
- •When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 1 month
- •When screening, Patients who took oral steroid within 2 weeks
- •Patients who can't take MRI scan
- •BMI index : 30kg/m^2 or over
- •Patients who have gout or gout history in the knee
- •Women who are pregnant or breast-feeding, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception.
- •Patients with risk factor for bleeding
- •Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial
研究组 & 干预措施
MegaCarti® application after Microfracture Surgery
The study group is applied with MegaCarti® after microfracture. Afterwards, they visit at 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires.
干预措施: MegaCarti® (Device)
MegaCarti® application after Microfracture Surgery
The study group is applied with MegaCarti® after microfracture. Afterwards, they visit at 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires.
干预措施: Microfracture (Procedure)
Microfracture Surgery without Medical Devices
The control group undergoes microfracture and they visit at 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires.
干预措施: Microfracture (Procedure)
结局指标
主要结局
MOCART score
时间窗: From 48 weeks after surgery
The independent evaluator measure the MOCART score based on the MRI images taken at 48 weeks after surgery. The MOCART score is an index for evaluating the degree of restoration of cartilage tissue and consists of a total of 9 items. Each item is scored from 0 to a maximum of 20 points and added up. The MOCART score is 0 when the cartilage is in the worst condition, and 100 when it is in the best condition. In other words, when the clinical effect of tissue repair appears, it is evaluated as a score greater than 0.
次要结局
- KOOS(Baseline and 12, 24, 48 weeks after surgery)
- OAS(From 48 weeks after surgery)
- VAS(Baseline and 12, 24, 48 weeks after surgery)
- IKDC score(Baseline and 12, 24, 48 weeks after surgery)
- ICRS-CRA score(From 48 weeks after surgery)
- Cartilage Coverage Ratio(From 48 weeks after surgery)
- Histological Evaluation(From 48 weeks after surgery)