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| Name | Class |
|---|---|
| Zhongnan Hospital | OTHER |
| Second Hospital of Shanxi Medical University | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cartilage membrane surgery | Experimental | The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd. Cartilage regeneration membrane combined with microfracture surgery. |
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| Microfracture | Other | The control group was treated with microfractures widely recognized at home and abroad. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided cartilage regeneration membrane | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| MRI evaluation of articular cartilage injury 730 days (2 years) after repair | The nuclear magnetic evaluation indicators are as follows:
The MRI score of the experimental group before and after treatment increased by an average of 5 points compared with the control group. | End of surgery to 730 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 24 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Those who have participated in clinical trials of other drugs or medical devices in the last 6 months
Those with stage III or above degeneration of bone and joint
Those who cannot accept pig-derived devices or have special religious beliefs due to religion, ethnicity and other issues
Those who are sensitive to collagen, foreign protein or pig-derived materials
Repair the damaged area> 8 cm2 or <2 cm2, lack of normal cartilage tissue around the injury
Severe heart, liver and kidney insufficiency are defined as:
Heart function: NYHA grade III or above; ALT, AST> 2.5 times the upper limit of normal value; Serum creatinine> 1.5 times the upper limit of normal value;
People with systemic immune diseases or systemic or local infections
Joint fibrosis, joint stiffness, and obviously restricted movement
Those with moderate or severe osteoarthritis
People with contraindications for MRI examination
Patients with hemophilia
Those who cannot tolerate surgery
Women who are pregnant or plan to become pregnant and breastfeeding women
Persons with mental abnormalities and incapacity to act autonomously
Other conditions that the doctor judges cannot participate in the trial
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingfang Ao, PhD | Contact | 13401096777 | 13401096777 | gcrm_bys01@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yingfang Ao, PhD | Department of Sports Medicine, Peking University Third Hospital | Principal Investigator |
| Xiaoqing Hu, PhD | Department of Sports Medicine, Peking University Third Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D054544 | Arthroplasty, Subchondral |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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| First Affiliated Hospital of Kunming Medical University |
| OTHER |
| Zunyi Medical College | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Chinese PLA General Hospital | OTHER |
| Xi'an Honghui Hospital | OTHER |
GCRM-3020\GCRM-4030
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| Microfracture | Procedure | Operate in accordance with the clinical microfracture surgery method. |
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| 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. |
| At 24 months after surgery |
| Zunyi Medical College | Zunyi | Guizhou | 563000 | China |
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| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450000 | China |
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| Zhongnan Hospital | Wuhan | Hubei | 430071 | China |
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| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
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| Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030012 | China |
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| Xi'an Honghui Hospital | Xi’an | Shanxi | 710000 | China |
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| The First Affiliated Hospital of Kunming Medical College | Kunming | Yunnan | 650032 | China |
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