This Clinical Trial Evaluated the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Patients With Cartilage Defects in Their Ankles.
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- 100mmVAS(visual analogue scale) score
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 in patients with cartilage defects in their ankles.
详细描述
This study was an open-trial study. Sixty 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 randomization table. They were asked to follow the guidelines of the investigators during the study and to visit the hospital five times, including for screening. At each visit, the subjects underwent an examination with doctors and MRI to evaluate the efficacy of the procedure. (*If the subject began the first visit on the screening date, the total number of his or her visits was four.)
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 who were 15 years old or older
- •Patients with cartilage defects in their ankle
- •Patients with misalignment of their tibia and talus, unstable ligament in their ankle, or bony defects in the lesions of their ankle, and/or who had been treated for alignment
- •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.)
研究组 & 干预措施
modified microfracture using collagen
modified microfracture using collagen (CartiFill) for cartilage defect of ankle
干预措施: Microfracture (Procedure)
modified microfracture using collagen
modified microfracture using collagen (CartiFill) for cartilage defect of ankle
干预措施: CartiFill (Device)
microfracture
simple microfracture for cartilage defect of ankle
干预措施: Microfracture (Procedure)
结局指标
主要结局
100mmVAS(visual analogue scale) score
时间窗: 12 months after the surgery
The VAS's were evaluated 12 months after the surgery on the affected ankle in the study and control groups.
次要结局
- Change score of 100mmVAS(visual analogue scale)(Screening, 6, 12, and 24months after surgery)
- Change of Satisfaction evaluation by patients(Screening, 6, 12, and 24months after surgery)
- Change of AOFAS(American orthopaedic foot & ankle society) Score(Screening, 6, 12, and 24months after surgery)
- Change of Hannover Score(Screening, 6, 12, and 24months after surgery)
- Change of Satisfaction evaluation by physician in charge(Screening, 6, 12, and 24months after surgery)
- Change results of Arthroscopy (ICRS(International Cartilage Repair Society))(before and 24 months after the surgery)
- the result of MRI(mMOCART)(24 months after the surgery)