Status:
UNKNOWN
Guided Cartilage Regeneration Membrane
Lead Sponsor:
Peking University Third Hospital
Collaborating Sponsors:
Zhongnan Hospital
Second Hospital of Shanxi Medical University
Conditions:
Articular Cartilage Injury
Knee Ligament Injury
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury
Detailed Description
MRI evaluation using guided cartilage regeneration membrane for articular cartilage injury repair 730 days (2 years) is the main indicator of this trial. In this experiment, we observe the improvement...
Eligibility Criteria
Inclusion
- ≥18 years old and ≤50 years old, regardless of gender
- 2 cm2 ≤ articular cartilage defect repair area ≤ 8 cm2, patients with feasible micro-fractures, no contraindications to surgery
- Patients voluntarily participate in clinical trials, sign informed consent forms, and can cooperate with clinical follow-up
Exclusion
- Those who have participated in clinical trials of other drugs or medical devices in the last 6 months
- Those with stage III or above degeneration of bone and joint
- Those who cannot accept pig-derived devices or have special religious beliefs due to religion, ethnicity and other issues
- Those who are sensitive to collagen, foreign protein or pig-derived materials
- Repair the damaged area\> 8 cm2 or \<2 cm2, lack of normal cartilage tissue around the injury
- 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;
- People with systemic immune diseases or systemic or local infections
- Joint fibrosis, joint stiffness, and obviously restricted movement
- Those with moderate or severe osteoarthritis
- People with contraindications for MRI examination
- Patients with hemophilia
- Those who cannot tolerate surgery
- Women who are pregnant or plan to become pregnant and breastfeeding women
- Persons with mental abnormalities and incapacity to act autonomously
- Other conditions that the doctor judges cannot participate in the trial
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 3 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04463238
Start Date
August 3 2020
End Date
August 3 2023
Last Update
July 9 2020
Active Locations (8)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
2
Zunyi Medical College
Zunyi, Guizhou, China, 563000
3
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
4
Zhongnan Hospital
Wuhan, Hubei, China, 430071