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

NCT ID: NCT04955548

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Articular Cartilage Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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arthroscopic microfracture with autologous adipose gel

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

Group Type EXPERIMENTAL

arthroscopic micro-fracture with autologous adipose gel

Intervention Type PROCEDURE

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 microfracture

The control group will be treated with arthroscopic microfracture.

Group Type ACTIVE_COMPARATOR

arthroscopic micro-fracture

Intervention Type PROCEDURE

Surgeons routinely perform international standard micro-fracture surgery to repair cartilage damage

Interventions

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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

Intervention Type PROCEDURE

arthroscopic micro-fracture

Surgeons routinely perform international standard micro-fracture surgery to repair cartilage damage

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingfang Ao, Prof.

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Xiaoqing Hu, Ph.D.

Role: CONTACT

18811332558

Yingfang Ao, Prof.

Role: CONTACT

18811332558

Other Identifiers

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M2020311

Identifier Type: -

Identifier Source: org_study_id

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