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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Articular Cartilage Defects
• Intervention / Treatment: Procedure: arthroscopic micro-fracture with autologous adipose gel; Procedure: arthroscopic micro-fracture

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.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoqing Hu, Ph.D.; Phone Number: 18811332558; Email: caochenxi116@163.com
• Study Contact Backup: Name: Yingfang Ao, Prof.; Phone Number: 18811332558; Email: aoyingfang@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Yingfang Ao, Prof., Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: M2020311

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No