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

Articular Cartilage Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04955548
• Other study ID #: M2020311
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: Xiaoqing Hu, Ph.D.
• Phone: 18811332558
• Email: caochenxi116[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Articular Cartilage Defects

Intervention

Procedure:
• arthroscopic 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
• arthroscopic micro-fracture
Surgeons routinely perform international standard micro-fracture surgery to repair cartilage damage

Locations

Country	Name	City	State
China	Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries, Beijing, China	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.