Study Results
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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UNKNOWN
NA
150 participants
INTERVENTIONAL
2020-08-03
2023-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cartilage membrane surgery
The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd.
Cartilage regeneration membrane combined with microfracture surgery.
Guided cartilage regeneration membrane
On the basis of microfracture, the blood clot released from the defect area is covered with a guide cartilage regeneration membrane to provide an attached scaffold for the cells in the blood clot.
Microfracture
Operate in accordance with the clinical microfracture surgery method.
Microfracture
The control group was treated with microfractures widely recognized at home and abroad.
Microfracture
Operate in accordance with the clinical microfracture surgery method.
Interventions
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Guided cartilage regeneration membrane
On the basis of microfracture, the blood clot released from the defect area is covered with a guide cartilage regeneration membrane to provide an attached scaffold for the cells in the blood clot.
Microfracture
Operate in accordance with the clinical microfracture surgery method.
Eligibility Criteria
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Inclusion Criteria
2. 2 cm2 ≤ articular cartilage defect repair area ≤ 8 cm2, patients with feasible micro-fractures, no contraindications to surgery
3. Patients voluntarily participate in clinical trials, sign informed consent forms, and can cooperate with clinical follow-up
Exclusion Criteria
2. Those with stage III or above degeneration of bone and joint
3. Those who cannot accept pig-derived devices or have special religious beliefs due to religion, ethnicity and other issues
4. Those who are sensitive to collagen, foreign protein or pig-derived materials
5. Repair the damaged area\> 8 cm2 or \<2 cm2, lack of normal cartilage tissue around the injury
6. Severe heart, liver and kidney insufficiency are defined as:
Heart function: NYHA grade III or above; ALT, AST\> 2.5 times the upper limit of normal value; Serum creatinine\> 1.5 times the upper limit of normal value;
7. People with systemic immune diseases or systemic or local infections
8. Joint fibrosis, joint stiffness, and obviously restricted movement
9. Those with moderate or severe osteoarthritis
10. People with contraindications for MRI examination
11. Patients with hemophilia
12. Those who cannot tolerate surgery
13. Women who are pregnant or plan to become pregnant and breastfeeding women
14. Persons with mental abnormalities and incapacity to act autonomously
15. Other conditions that the doctor judges cannot participate in the trial
18 Years
50 Years
ALL
No
Sponsors
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Zhongnan Hospital
OTHER
Second Hospital of Shanxi Medical University
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
First Affiliated Hospital of Kunming Medical University
OTHER
Zunyi Medical College
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Chinese PLA General Hospital
OTHER
Xi'an Honghui Hospital
OTHER
Peking University Third Hospital
OTHER
Responsible Party
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Principal Investigators
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Yingfang Ao, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Sports Medicine, Peking University Third Hospital
Xiaoqing Hu, PhD
Role: STUDY_DIRECTOR
Department of Sports Medicine, Peking University Third Hospital
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Zunyi Medical College
Zunyi, Guizhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhongnan Hospital
Wuhan, Hubei, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Xi'an Honghui Hospital
Xi’an, Shanxi, China
The First Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Zhongli Li, PhD
Role: primary
Yi Liu, Bachelor
Role: primary
Jianzhong Xu, PhD
Role: primary
Liaobin Chen, PhD
Role: primary
Qing Jiang, PhD
Role: primary
Zhiqiang Zhang, Postgraduate
Role: primary
Jiang Zheng, PhD
Role: primary
Yanlin Li, PhD
Role: primary
Other Identifiers
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2015035
Identifier Type: -
Identifier Source: org_study_id
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