CClinicalTrials.gg
Status unknownNCT04955548Updated Jul 8, 2021

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

An interventional study of arthroscopic micro-fracture with autologous adipose gel and arthroscopic micro-fracture in Articular Cartilage Defects, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-07-08.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Articular Cartilage Defects
03

In context

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
66 participants (estimated)

Study arms

  • 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

  • Active comparator
    arthroscopic microfracture

    The control group will be treated with arthroscopic microfracture.

    Procedure: arthroscopic micro-fracture

Interventions

  • Procedurearthroscopic 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

  • Procedurearthroscopic micro-fracture

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Knee MRI examinations were performed on patients baseline, 5 days, 90 days, 180 days, and 365 days after operation.

Secondary outcomes

  1. Lysholm score

    Assessing a change of Lysholm score between two groups of patients

    Time frame: Lysholm score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.

  2. IKDC score

    Assessing a change of IKDC score between two groups of patients

    Time frame: IKDC score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.

  3. Tegner score

    Assessing a change of Tegner score between two groups of patients

    Time frame: Tegner score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.

  4. VAS score

    Assessing a change of VAS score between two groups of patients

    Time frame: VAS score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.

07

Study locations

1 site
  • Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries, Beijing, China
    Beijing, Beijing 100191, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04955548
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Jul 8, 2021
Start date
Dec 1, 2021 (estimated)
Primary completion
Dec 1, 2022 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Jul 8, 2021

Study contacts

Xiaoqing Hu, Ph.D.
Contact
caochenxi116@163.com
18811332558
Yingfang Ao, Prof.
Contact
aoyingfang@163.com
18811332558
Yingfang Ao, Prof.
principal investigator · Peking University Third Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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