A Clinical Translational Study on Repairing Articular Cartilage Injury With Autologous Adipose Gel

Peking University

Status: Unknown

Conditions: Articular Cartilage Defects

Treatments: Procedure: arthroscopic micro-fracture; Procedure: arthroscopic micro-fracture with autologous adipose gel

Study type: Interventional

Funder types: Other

Identifiers

NCT04955548

M2020311

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

arthroscopic microfracture with autologous adipose gel

Experimental group

Description:

The experimental group will be treated with arthroscopic microfracture with autologous adipose gel.

Treatment:

Procedure: arthroscopic micro-fracture with autologous adipose gel

arthroscopic microfracture

Active Comparator group

Description:

The control group will be treated with arthroscopic microfracture.

Treatment:

Procedure: arthroscopic micro-fracture