Guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury
MRI evaluation using guided cartilage regeneration membrane for articular cartilage injury repair 730 days (2 years) is the main indicator of this trial. In this experiment, we observe the improvement of Lysholm score, VAS score, ratio change of regenerated cartilage T2 value to normal cartilage T2 value, and ratio of regenerated cartilage △R1 value to normal cartilage △R1 value Indicators such as value changes are secondary evaluation indicators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
On the basis of microfracture, the blood clot released from the defect area is covered with a guide cartilage regeneration membrane to provide an attached scaffold for the cells in the blood clot.
Operate in accordance with the clinical microfracture surgery method.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Zunyi Medical College
Zunyi, Guizhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhongnan Hospital
Wuhan, Hubei, China
MRI evaluation of articular cartilage injury 730 days (2 years) after repair
The nuclear magnetic evaluation indicators are as follows: 1. Cartilage defect repair filling degree; 2. Fusion of repair tissue and adjacent normal cartilage; 3. Repair tissue surface structure; 4. Repair the internal structure of the organization. The MRI score of the experimental group before and after treatment increased by an average of 5 points compared with the control group.
Time frame: End of surgery to 730 days after surgery
Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value
The closer the ratio of the regenerated cartilage T2 value to the normal control cartilage T2 value is 1, it means that the regenerated cartilage The closer the water content and collagen arrangement are to normal cartilage.
Time frame: At 24 months after surgery
Change in ratio of regenerated cartilage △R1 value to normal cartilage △R1 value
The closer the ratio of the regenerated cartilage △R1 value to the normal control cartilage △R1 value is 1, it means that the GAG content of regenerated cartilage is closer to normal cartilage.
Time frame: At 24 months after surgery
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Xi'an Honghui Hospital
Xi’an, Shanxi, China
The First Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, China