Injury to articular cartilage
Conditions
Interventions
Intervention group:Cartilage Regeneration Collagen Filler Stent - ChondroFiller? Liquid Therapy
Control group:Traditional conservative treatment group
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged 18-65 years old (inclusive of both 18 and 65 years old), of either gender; 2.Focal cartilage injury, with normal cartilage surrounding the lesion; 3.Cartilage injury with ICRS grade III or IV, with a defect area of <=3 cm^2; 4.The patient is able to understand the purpose of the trial, voluntarily participates in the study, and is willing to sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Body Mass Index (BMI) >= 35 kg/m^2 (BMI = weight divided by height squared); 2. Those with severe joint ankylosis or joint fibrosis; 3. Patients with varus or valgus of the lower limb axis >5° who require correction of the lower limb alignment; 4. Patients with multiple ligament injuries in the joints or with more than 1/3 of the meniscus removed; 5. The intended treatment area has undergone arthroscopic debridement and/or received microfracture surgery, mosaicplasty, or autologous cartilage implantation within the past 3 months; 6. According to the Kellgren-Lawrence classification, the osteoarthritis of the affected knee is classified as grade 4; 7. Patients with infectious, autoimmune, or metabolic arthritis; 8. Those who have undergone open joint surgery within the past 6 months; 9. Those who have received steroid medications, Platelet-Rich Plasma (PRP), or intra-articular injections within the past 3 months; 10. Subjects with severe primary cardiovascular disease, pulmonary disease, endocrine and metabolic disease (severe diabetes, severe osteoporosis) or severe diseases affecting their survival, which the investigator deems unsuitable for enrollment; 11. Patients with connective tissue diseases, neurological diseases, or muscle degeneration; 12. Patients who are allergic to the following components and/or have known hypersensitivity reactions, such as those with a history of allergies to collagen, amino acids (especially glutamine, arginine, cysteine, lysine, histidine), and rat proteins; 13. Women who are pregnant or breastfeeding, or who plan to become pregnant during the trial period, and who have a positive blood pregnancy test result before the trial; 14.Individuals who have participated or are currently participating in a drug clinical trial within the past 3 months, or in another medical device clinical trial within the past 30 days; 15. Other conditions that, according to the researchers' judgment, make the subjects unsuitable for enrollment in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in IKDC score at 12 months post-surgery compared to baseline;MOCART score at 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in MOCART score at 6 months post-surgery compared to the baseline period;Changes in IKDC scores at 3 months and 6 months post-surgery compared to the baseline period;Changes in Lysholm scores from baseline at 3 months, 6 months, and 12 months after surgery;Changes in KOOS scores at 3 months, 6 months, and 12 months post-surgery compared to the baseline period;Changes in AOFAS scores at 3 months, 6 months, and 12 months post-surgery compared to the baseline period;Changes in VAS scores compared to baseline at 3 months, 6 months, and 12 months after surgery;Evaluation of equipment performance;Adverse events; | — |
Countries
China
Contacts
Public ContactChen Shiyi
Huashan Hospital, Fudan University
Outcome results
None listed