Clinical trial NCT04463238: Guided Cartilage Regeneration Membrane
Official title: Randomized Open Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Guided Cartilage Regeneration Membrane for Repair of Articular Cartilage Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Articular Cartilage Injury
Knee Ligament Injury
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Zhongnan Hospital
name: Second Hospital of Shanxi Medical University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: First Affiliated Hospital of Kunming Medical University
name: Zunyi Medical College
name: The First Affiliated Hospital of Zhengzhou University
name: Chinese PLA General Hospital
name: Xi'an Honghui Hospital
First posted: 2020-07-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: GCRM-3020\\GCRM-4030
Primary purpose: TREATMENT

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 of Lysholm score, VAS score, ratio change of regenerated cartilage T2 value to normal cartilage T2 value, and ratio of regenerated cartilage △R1 value to normal cartilage △R1 value Indicators such as value changes are secondary evaluation indicators.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years old and ≤50 years old, regardless of gender
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:

1. Those who have participated in clinical trials of other drugs or medical devices in the last 6 months
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

Primary outcomes:
measure: MRI evaluation of articular cartilage injury 730 days (2 years) after repair
timeFrame: End of surgery to 730 days after surgery
Secondary outcomes:
measure: Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value
timeFrame: At 24 months after surgery
measure: Change in ratio of regenerated cartilage △R1 value to normal cartilage △R1 value
timeFrame: At 24 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing Municipality
city: Zunyi
country: China
facility: Zunyi Medical College
state: Guizhou
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Zhongnan Hospital
state: Hubei
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: Xi'an Honghui Hospital
state: Shanxi
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical College
state: Yunnan
Study officials:
affiliation: Department of Sports Medicine, Peking University Third Hospital
name: Yingfang Ao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Sports Medicine, Peking University Third Hospital
name: Xiaoqing Hu, PhD
role: STUDY_DIRECTOR
References: