Chondro-Gide® Bilayer Collagen Membrane in Knee Cartilage Defect Repair

Inclusion Criteria:

1. Male or female patients aged 18-55 years (including 18 years and 55 years);

2. Localized cartilage defects on knee joint, the size of the defect after debridementis 2.0 squared cm - 8.0 squared cm (including 2.0 squared cm and 8.0 squared cm),which was classified by the International Cartilage Repair Society (ICRS) as grade Ⅲor grade IV;

3. The subjects voluntarily consent to participate in this trial and sign the informedconsent form (ICF).

Exclusion Criteria:

1. Body mass index (BMI) ≥ 30 kg/meter squared (BMI = weight divided by heightsquared);

2. Unilateral knee cartilage defect with the ICRS classification of grade III or gradeIV, and with three or more defects;

3. Patients with abnormal lower limb mechanical axis requiring correction, except thosethat could be corrected during the treatment of cartilage injury;

4. Varus or valgus of lower limb axis > 5°, requiring osteotomy for correction;

5. Patients with multiple ligament injury or total meniscectomy;

6. Those who are known to be allergic to porcine-derived materials or collagen, orrefuse to use porcine-derived medical products;

7. Those with severe arthroclisis or arthrofibrosis;

8. Those who have received open knee surgery in the past 6 months;

9. Those who have received microfracture, mosaicplasty or autologous cartilageimplantation in the past 3 months;

10. Those who have serious primary cardiovascular diseases, lung diseases, endocrine andmetabolic diseases (severe diabetes, severe osteoporosis) or serious diseasesaffecting their survival, and are considered unsuitable for inclusion by theinvestigators;

11. Pregnant and lactating women, or those who plan to conceive during the trial, andthose who have positive blood/urine pregnancy test results before the trial;

12. Patients with knee infection；

13. Those with connective tissue diseases;

14. Those with nervous system diseases or muscle degeneration;

15. Patients who participated in drug clinical trials within 3 months prior to theenrollment or patients who participated in any other device clinical trials within 1months prior to the enrollment;

16. Other circumstances which are considered by the investigator not suitable forenrollment in this study.