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

Study Overview
=================
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.

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

Conditions
-----------------
Articular Cartilage Defects

Intervention / Treatment
-----------------
* Procedure: arthroscopic micro-fracture with autologous adipose gel
* Procedure: arthroscopic micro-fracture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years old and ≤50 years old, male or female patients Patients with knee articular cartilage defect area ≥2cm2 and ≤8cm2, who can undergo microfracture surgery, no surgical contraindications Patients voluntarily participate in clinical trials, sign an informed consent form, and be able to cooperate with clinical follow-up Exclusion Criteria: Participants in clinical trials of other drugs or medical devices in the past 6 months Unable to accept autologous fat glue due to religion, ethnicity, etc. Injury area <2 cm2 or >8cm2 or lack of normal cartilage tissue surrounding the injury Those with compound multiple ligament injuries Those with systemic immune diseases or systemic or local infections Those with joint fibrosis, joint ankylosis, and obvious limitation of movement People with moderate to severe osteoarthritis Those who have contraindications to MRI examination Patients with hemophilia People whose general condition cannot tolerate surgery Women who are pregnant or planning to become pregnant and women who are breastfeeding Mental abnormalities and no behavioral autonomy Other circumstances in which the doctor judges that he cannot participate in the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: arthroscopic microfracture with autologous adipose gel<br>The experimental group will be treated with arthroscopic microfracture with autologous adipose gel. | Procedure: arthroscopic micro-fracture with autologous adipose gel<br>* 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<br>|
| Active Comparator: arthroscopic microfracture<br>The control group will be treated with arthroscopic microfracture. | Procedure: arthroscopic micro-fracture<br>* Surgeons routinely perform international standard micro-fracture surgery to repair cartilage damage<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing a change of MRI Evaluation of Articular Cartilage Injury after Repair | Assessing a change of postoperative MRI evaluation with autologous fat glue combined with micro-fracture treatment or micro-fracture treatment articular cartilage injury | Knee MRI examinations were performed on patients baseline, 5 days, 90 days, 180 days, and 365 days after operation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysholm score | Assessing a change of Lysholm score between two groups of patients | Lysholm score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation. | 
| IKDC score | Assessing a change of IKDC score between two groups of patients | IKDC score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation. | 
| Tegner score | Assessing a change of Tegner score between two groups of patients | Tegner score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation. | 
| VAS score | Assessing a change of VAS score between two groups of patients | VAS score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation. |