Articular Cartilage DefectsNCT04955548
A Clinical Translational Study on Repairing Articular Cartilage Injury With Autologous Adipose Gel
A study testing arthroscopic micro-fracture with autologous adipose gel and arthroscopic micro-fracture in people with Articular Cartilage Defects, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Articular Cartilage Defects
- What is being tested?
- arthroscopic micro-fracture with autologous adipose gel and arthroscopic micro-fracture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ≥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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Sports Medicine, Peking University Third Hospital, Beijing Key Laboratory of Sports Injuries， Beijing, China
Beijing, Beijing Municipality, 100191
About this study
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.
- Conditions
- Articular Cartilage Defects
- Being tested
- arthroscopic micro-fracture with autologous adipose gel, arthroscopic micro-fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic micro-fracture with autologous adipose gelProcedure or surgery
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 micro-fractureProcedure or surgery
Surgeons routinely perform international standard micro-fracture surgery to repair cartilage damage
| Study group | Role | What they receive |
|---|---|---|
| arthroscopic microfracture with autologous adipose gel | Experimental | The experimental group will be treated with arthroscopic microfracture with autologous adipose gel. Receives: Procedure: arthroscopic micro-fracture with autologous adipose gel |
| arthroscopic microfracture | Active comparator | The control group will be treated with arthroscopic microfracture. Receives: Procedure: arthroscopic micro-fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Knee MRI examinations were performed on patients baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Secondary outcomes (4)
Lysholm score
Assessing a change of Lysholm score between two groups of patients
Measured: 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
Measured: 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
Measured: 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
Measured: VAS score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage DefectsStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingfang Ao, Prof., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955548
- Sponsor's protocol ID
- M2020311
- Status last verified
- Jul 2021
- First submitted
- 25 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Translational Study on Repairing Articular Cartilage Injury With Autologous Adipose Gel
- ClinicalTrials.gov ID
- NCT04955548
- Acronym / sponsor ID
- M2020311
- Conditions
- Articular Cartilage Defects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arthroscopic microfracture with autologous adipose gel | Experimental | Procedure: arthroscopic micro-fracture with autologous adipose gelThe experimental group will be treated with arthroscopic microfracture with autologous adipose gel. |
| arthroscopic microfracture | Active comparator | Procedure: arthroscopic micro-fractureThe control group will be treated with arthroscopic microfracture. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ≥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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arthroscopic micro-fracture with autologous adipose gelFully 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 | Procedure or surgery | arthroscopic microfracture with autologous adipose gel |
| arthroscopic micro-fractureSurgeons routinely perform international standard micro-fracture surgery to repair cartilage damage | Procedure or surgery | arthroscopic microfracture |
Primary outcome
Assessing a change of MRI Evaluation of Articular Cartilage Injury after Repair
Time frame: 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
4 secondary outcomes
Lysholm score
Time frame: Lysholm score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
IKDC score
Time frame: IKDC score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Tegner score
Time frame: Tegner score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
VAS score
Time frame: VAS score was tested for the two groups of patients' baseline, 5 days, 90 days, 180 days, and 365 days after operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingfang Ao, Prof. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopic micro-fracture with autologous adipose gel and arthroscopic micro-fracture in people with Articular Cartilage Defects, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoqing Hu, Ph.D. (18811332558, caochenxi116@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing a change of MRI Evaluation of Articular Cartilage Injury after Repair (time frame: Knee MRI examinations were performed on patients baseline, 5 days, 90 days, 180 days, and 365 days after operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.