Articular Cartilage Defects
Conditions
Brief summary
66 articular cartilage injury diseases patients were divided into two groups as 1:1. The test group will be treated with arthroscopic micro-fracture with autologous adipose gel, and the control group will be treated with arthroscopic micro-fracture. Postoperative MRI evaluation, Lysholm score, IKDC score, Tegner score, and VAS score will be used as the treatment validity evaluation index, at the same time testing blood routine, blood biochemistry, urine routine, CRP, electrocardiogram and other laboratory tests and recording the occurrence of adverse events.
Detailed description
In this study, 66 patients who were clinically diagnosed as articular cartilage injury diseases were divided into test group and control group according to the ratio of 1:1. The test group will be treated with arthroscopic micro-fracture with autologous adipose gel, and the control group will be treated with arthroscopic micro-fracture. Postoperative MRI evaluation, Lysholm score, IKDC score, Tegner score, and VAS score will be used as the treatment validity evaluation index, at the same time testing blood routine, blood biochemistry, urine routine, CRP, electrocardiogram and other laboratory tests and recording the occurrence of adverse events.
Interventions
PROCEDUREarthroscopic micro-fracture with autologous adipose gel
Fully cut the adipose tissue taken out under the arthroscopy, transfer the cut adipose tissue to a syringe connected with a double pass, push back and forth through the syringe to physically emulsify the adipose, and centrifuge to obtain the autologous adipose gel, and inject it into the lesion
PROCEDUREarthroscopic micro-fracture
Surgeons routinely perform international standard micro-fracture surgery to repair cartilage damage
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old and ≤50 years old, male or female patients 2. Patients with knee articular cartilage defect area ≥2cm2 and ≤8cm2, who can undergo microfracture surgery, no surgical contraindications 3. Patients voluntarily participate in clinical trials, sign an informed consent form, and be able to cooperate with clinical follow-up
Exclusion criteria
1. Participants in clinical trials of other drugs or medical devices in the past 6 months 2. Unable to accept autologous fat glue due to religion, ethnicity, etc. 3. Injury area \<2 cm2 or \>8cm2 or lack of normal cartilage tissue surrounding the injury 4. Those with compound multiple ligament injuries 5. Those with systemic immune diseases or systemic or local infections 6. Those with joint fibrosis, joint ankylosis, and obvious limitation of movement 7. People with moderate to severe osteoarthritis 8. Those who have contraindications to MRI examination 9. Patients with hemophilia 10. People whose general condition cannot tolerate surgery 11. Women who are pregnant or planning to become pregnant and women who are breastfeeding 12. Mental abnormalities and no behavioral autonomy 13. Other circumstances in which the doctor judges that he cannot participate in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing a change of MRI Evaluation of Articular Cartilage Injury after Repair | Knee MRI examinations were performed on patients baseline, 5 days, 90 days, 180 days, and 365 days after operation. | Assessing a change of postoperative MRI evaluation with autologous fat glue combined with micro-fracture treatment or micro-fracture treatment articular cartilage injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lysholm score | Lysholm score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation. | Assessing a change of Lysholm score between two groups of patients |
| IKDC score | IKDC score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation. | Assessing a change of IKDC score between two groups of patients |
| Tegner score | Tegner score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation. | Assessing a change of Tegner score between two groups of patients |
| VAS score | VAS score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation. | Assessing a change of VAS score between two groups of patients |
Countries
China
Contacts
Primary ContactXiaoqing Hu, Ph.D.
Backup ContactYingfang Ao, Prof.
Outcome results
None listed