A Clinical Translational Study on Repairing Articular Cartilage Injury With Autologous Adipose Gel
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2021
CompletedFirst Posted
Study publicly available on registry
July 8, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJuly 8, 2021
July 1, 2021
1 year
June 25, 2021
July 7, 2021
Conditions
Outcome Measures
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
Knee MRI examinations were performed on patients baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Secondary Outcomes (4)
Lysholm score
Lysholm score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
IKDC score
IKDC score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Tegner score
Tegner score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
VAS score
VAS score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Study Arms (2)
arthroscopic microfracture with autologous adipose gel
EXPERIMENTALThe experimental group will be treated with arthroscopic microfracture with autologous adipose gel.
arthroscopic microfracture
ACTIVE COMPARATORThe control group will be treated with arthroscopic microfracture.
Interventions
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
Surgeons routinely perform international standard micro-fracture surgery to repair cartilage damage
Eligibility Criteria
You may qualify if:
- ≥18 years old and ≤50 years old, male or female patients
- Patients with knee articular cartilage defect area ≥2cm2 and ≤8cm2, who can undergo microfracture surgery, no surgical contraindications
- Patients voluntarily participate in clinical trials, sign an informed consent form, and be able to cooperate with clinical follow-up
You may not qualify if:
- Participants in clinical trials of other drugs or medical devices in the past 6 months
- Unable to accept autologous fat glue due to religion, ethnicity, etc.
- Injury area \<2 cm2 or \>8cm2 or lack of normal cartilage tissue surrounding the injury
- Those with compound multiple ligament injuries
- Those with systemic immune diseases or systemic or local infections
- Those with joint fibrosis, joint ankylosis, and obvious limitation of movement
- People with moderate to severe osteoarthritis
- Those who have contraindications to MRI examination
- Patients with hemophilia
- People whose general condition cannot tolerate surgery
- Women who are pregnant or planning to become pregnant and women who are breastfeeding
- Mental abnormalities and no behavioral autonomy
- Other circumstances in which the doctor judges that he cannot participate in the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
Beijing, Beijing Municipality, 100191, China
Study Officials
- PRINCIPAL INVESTIGATOR
Yingfang Ao, Prof.
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2021
First Posted
July 8, 2021
Study Start
December 1, 2021
Primary Completion
December 1, 2022
Study Completion
December 1, 2023
Last Updated
July 8, 2021
Record last verified: 2021-07