Guided Cartilage Regeneration Membrane

Study Overview
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Brief Summary
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Guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury

Detailed Description
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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.

Official Title
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Randomized Open Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Guided Cartilage Regeneration Membrane for Repair of Articular Cartilage Injury

Conditions
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Articular Cartilage Injury, Knee Ligament Injury

Intervention / Treatment
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* Combination Product: Guided cartilage regeneration membrane
* Procedure: Microfracture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old and ≤50 years old, regardless of gender 2 cm2 ≤ articular cartilage defect repair area ≤ 8 cm2, patients with feasible micro-fractures, no contraindications to surgery Patients voluntarily participate in clinical trials, sign informed consent forms, and can cooperate with clinical follow-up 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: GCRM-3020\GCRM-4030
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cartilage membrane surgery<br>The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd. Cartilage regeneration membrane combined with microfracture surgery. | Combination Product: Guided cartilage regeneration membrane<br>* 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.<br>Procedure: Microfracture<br>* Operate in accordance with the clinical microfracture surgery method.<br>|
| Other: Microfracture<br>The control group was treated with microfractures widely recognized at home and abroad. | Procedure: Microfracture<br>* Operate in accordance with the clinical microfracture surgery method.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI evaluation of articular cartilage injury 730 days (2 years) after repair | The nuclear magnetic evaluation indicators are as follows: Cartilage defect repair filling degree; Fusion of repair tissue and adjacent normal cartilage; Repair tissue surface structure; 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. | End of surgery to 730 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |