Articular Cartilage Injury, Knee Ligament Injury
Conditions
Brief summary
Guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury
Detailed description
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.
Interventions
COMBINATION_PRODUCTGuided cartilage regeneration membrane
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.
PROCEDUREMicrofracture
Operate in accordance with the clinical microfracture surgery method.
Sponsors
Zhongnan Hospital
Second Hospital of Shanxi Medical University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
First Affiliated Hospital of Kunming Medical University
Zunyi Medical College
The First Affiliated Hospital of Zhengzhou University
Chinese PLA General Hospital
Xi'an Honghui Hospital
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
GCRM-3020\\GCRM-4030
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old and ≤50 years old, regardless of gender 2. 2 cm2 ≤ articular cartilage defect repair area ≤ 8 cm2, patients with feasible micro-fractures, no contraindications to surgery 3. Patients voluntarily participate in clinical trials, sign informed consent forms, and can cooperate with clinical follow-up
Exclusion criteria
1. Those who have participated in clinical trials of other drugs or medical devices in the last 6 months 2. Those with stage III or above degeneration of bone and joint 3. Those who cannot accept pig-derived devices or have special religious beliefs due to religion, ethnicity and other issues 4. Those who are sensitive to collagen, foreign protein or pig-derived materials 5. Repair the damaged area\> 8 cm2 or \<2 cm2, lack of normal cartilage tissue around the injury 6. 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; 7. People with systemic immune diseases or systemic or local infections 8. Joint fibrosis, joint stiffness, and obviously restricted movement 9. Those with moderate or severe osteoarthritis 10. People with contraindications for MRI examination 11. Patients with hemophilia 12. Those who cannot tolerate surgery 13. Women who are pregnant or plan to become pregnant and breastfeeding women 14. Persons with mental abnormalities and incapacity to act autonomously 15. Other conditions that the doctor judges cannot participate in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI evaluation of articular cartilage injury 730 days (2 years) after repair | End of surgery to 730 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value | At 24 months after surgery | 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. |
| Change in ratio of regenerated cartilage △R1 value to normal cartilage △R1 value | At 24 months after surgery | 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. |
Countries
China
Contacts
Primary ContactYingfang Ao, PhD
Outcome results
None listed