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

Not Applicable

• Conditions: Articular Cartilage Defects
• Interventions: Procedure: arthroscopic micro-fracture with autologous adipose gel; Procedure: arthroscopic micro-fracture

• Registration Number: NCT04955548
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study First Submitted: 2021-06-25
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-07
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08
• Study Start: 2021-12-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arthroscopic microfracture with autologous adipose gel	arthroscopic micro-fracture with autologous adipose gel	The experimental group will be treated with arthroscopic microfracture with autologous adipose gel.
arthroscopic microfracture	arthroscopic micro-fracture	The control group will be treated with arthroscopic microfracture.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
IKDC score	IKDC score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.	Assessing a change of IKDC score between two groups of patients
VAS score	VAS score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.	Assessing a change of VAS score between two groups of patients
Lysholm score	Lysholm score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.	Assessing a change of Lysholm score between two groups of patients
Tegner score	Tegner score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.	Assessing a change of Tegner score between two groups of patients

Trial Locations

Locations (1)

Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China; 🇨🇳 Beijing, Beijing, China