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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- MOCART score
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.
The MegaCarti® is applied after Microfracture treatment on patients with Knee Cartilage Defects. The cartilage regeneration, which is a primary endpoint, is compared to the Microfracture group through MOCART evaluation. In addition, the improvement of pain and the recovery of Normal Range of motion are compared to the Microfracture group through secondary endpoints. Then, long-term follow-up study for 5 years is conducted to the experimental group.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years to 65 years
- •Patients or legal representatives who voluntarily decide to participate in the clinical trial, after which sign the consent form.
- •Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage
- •Patients 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 : Below 10 ㎠
排除标准
- •Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
- •Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (Possible for HTO surgery)
- •When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 3 months
- •When screening, Patients who took oral steroid within 1 month
- •When screening, Patients who have clinically significant abnormalities in blood, serum, or urine tests
- •Patients taking immunosuppressive drug, or having immune disorder
- •Patients who can't take MRI scan
- •Patients with a history of cancer within the past five years
- •Patients who have chronic renal failure, active hepatitis, or poor blood sugar control
- •BMI index : 30 ㎏/㎡ or over
- •Patients who have gout or gout history in the knee
- •When screening, Women who are pregnant or breast-feeding, or women who are planning for pregnancy during the clinical trial, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception.
- •Drug and alcohol addiction / dependence or mental disorder
- •Patients with risk factor for bleeding (Patients taking antithrombotic drugs other than aspirin)
- •Patients who have systemic or localized knee infection
- •Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial
- •Patients who participated in other clinical trials within three months before screening
研究组 & 干预措施
MegaCarti® application after microfracture
The experimental group is applied with MegaCarti® after microfracture. Afterwards, they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires. Long-term follow-up Study is performed to subject that completes 48-week visit, at every 6 months for 5 years.
干预措施: MegaCarti® (Device)
MegaCarti® application after microfracture
The experimental group is applied with MegaCarti® after microfracture. Afterwards, they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires. Long-term follow-up Study is performed to subject that completes 48-week visit, at every 6 months for 5 years.
干预措施: Microfracture (Procedure)
Microfracture only
The control group undergoes microfracture and they visit at 6 weeks, 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: 48 weeks after surgery
Primary Endpoint \[experimental group / control group\]
次要结局
- Comparison of KOOS score(Baseline and 12, 24, 48 weeks after surgery)
- Comparison of IKDC score(Baseline and 12, 24, 48 weeks after surgery)
- Comparison of WOMAC score(Baseline and 12, 24, 48 weeks after surgery)
- Comparison of VAS score(Baseline and 6, 12, 24, 48 weeks after surgery)
- Frequency of rescue medication(For 48 weeks after surgery)
- Comparison of Kellgren-Lawrence grade(Baseline and 12, 24, 48 weeks after surgery)