Random Clinical Trial for Comparison of Efficacy and Safety of Simple Microfracture and Modified Microfracture Using Collagen in the Patients With Knee Cartilage Defects
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- 100mmVAS(Visual Analogue Scale)
研究概览
简要总结
This study was designed to evaluate the efficacy and safety of a modified microfracture using collagen, and to compare them with those of a simple microfracture to prove the non-inferiority of the modified microfracture using collagen in patients with cartilage defects in their knees.
详细描述
This study was an open-trial study. One hundred subjects participated in it. The study was explained to the subjects and they voluntarily agreed to participate in it. Their eligibility to participate in the study was checked, and they were randomized either into the simple microfracture group or the modified microfracture group using collagen based on a centrally controlled randomization table. They were asked to follow the guidelines of the investigators during the study and to visit the hospital six times*, including for screening. At each visit, the subjects underwent an examination with doctors, a blood test, an X-ray procedure, an MRI, an observation with the naked eyes, and arthroscopy to evaluate the safety and efficacy of the procedure. (*If the screening date overlaps with the procedure date, the number of his or her visits would be five.)
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
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with cartilage defects in their knee (Including Knee OA and Knee TA)
- •Knee osteoarthritis patients whose Kellgren-Lawrence Grading Scale score is lower than 3 (patients who received simultaneous or previous correction will be excluded).
- •Patients with misalignment of their tibia and femur, unstable ligament in their knee, or bony defects in the lesions of their knee, and/or who had been treated for alignment
- •Patients who were 15 years old or older
- •Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed consent form
排除标准
- •If patients or their families suffer from or have ever suffered from an autoimmune disease.
- •Patients who have ever suffered an anaphylactic reaction.
- •Patients who have ever suffered hypersensitivity to an implant.
- •Patients with a history of allergy to porcine or bovine protein.
- •Subjects with inflammatory arthritis, such as rheumatoid and gouty arthritis.
- •Subjects with autoimmune disease related arthritis.
- •Subjects who are pregnant and/or breast-feeding and/or plan a pregnancy.
- •Subjects with tumors.
- •Subjects who have undergone radiotherapy or chemotherapy within the last 2 years (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
- •Subjects who are diabetic. (Exception: if the possibility of CartiFill™ treatment is confirmed with doctor's clinical decision, and/or patient's blood glucose level remains within the normal range and/or no other complications by diabetes mellitus.)
- •Subjects with infections, currently on treatment with antibiotics or antimicrobials (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
- •Subjects under adrenocorticoid therapy (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
- •Subjects with psychiatric disorders who are considered inappropriate to participate in this trial by the Principal Investigator.
- •Patients who have ever suffered contraindications of the used Fibrin sealant. (The major contraindications are as follows: patients with hypersensitivity to aprotinin and those treatments for severe brisk arterial or venous bleeding.)
结局指标
主要结局
100mmVAS(Visual Analogue Scale)
时间窗: 12 month after surgery
It will be evaluated by the VAS score 12 months after surgery of the affected knee of the investigational group and the control group.
次要结局
- change of 100 mmVAS (Visual Analogue Scale)(screening, 3, 6, 12 and 24 months after surgery)
- change of Knee injury and osteoarthritis outcome (KOOS)(screening, 6, 12 and 24 months after surgery)
- change of International Knee Documentation Committee (IKDC)(screening, 6, 12 and 24 months after surgery)
- the results of MRI and MRI of articular cartilage examination (T2, T2 star, deGEMRIC, UTE, etc.), mMOCART(12 months after surgery)