Clinical trial NCT04955548: A Clinical Translational Study on Repairing Articular Cartilage Injury With Autologous Adipose Gel
Official title: A Clinical Translational Study on Repairing Articular Cartilage Injury With Autologous Adipose Gel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Articular Cartilage Defects
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessing a change of MRI Evaluation of Articular Cartilage Injury after Repair
timeFrame: Knee MRI examinations were performed on patients baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Secondary outcomes:
measure: Lysholm score
timeFrame: Lysholm score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
measure: IKDC score
timeFrame: IKDC score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
measure: Tegner score
timeFrame: Tegner score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
measure: VAS score
timeFrame: VAS score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yingfang Ao, Prof.
role: PRINCIPAL_INVESTIGATOR
References: