Guided Cartilage Regeneration Membrane

Knee Ligament Injury Clinical Trial

— GCRM  

Official title:

Randomized Open Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Guided Cartilage Regeneration Membrane for Repair of Articular Cartilage Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04463238
• Other study ID #: 2015035
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: August 3, 2023

Study information

• Verified date: July 2020
• Source: Peking University Third Hospital
• Contact: Yingfang Ao, PhD
• Phone: 13401096777
• Email: gcrm_bys01[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 3, 2023
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Articular Cartilage Injury
• Knee Ligament Injury
• Wounds and Injuries

Intervention

Combination Product:
• 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.

Procedure:
• Microfracture
Operate in accordance with the clinical microfracture surgery method.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing Municipality
China	The First Affiliated Hospital of Kunming Medical College	Kunming	Yunnan
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Zhongnan Hospital	Wuhan	Hubei
China	Xi'an Honghui Hospital	Xi'an	Shanxi
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Zunyi Medical College	Zunyi	Guizhou

Sponsors (9)

Lead Sponsor	Collaborator
Peking University Third Hospital	Chinese PLA General Hospital, Second Hospital of Shanxi Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Kunming Medical College, The First Affiliated Hospital of Zhengzhou University, Xi'an Honghui Hospital, Zhongnan Hospital, Zunyi Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI evaluation of articular cartilage injury 730 days (2 years) after repair	The nuclear magnetic evaluation indicators are as follows: Cartilage defect repair filling degree; Fusion of repair tissue and adjacent normal cartilage; Repair tissue surface structure; Repair the internal structure of the organization.; The MRI score of the experimental group before and after treatment increased by an average of 5 points compared with the control group.	End of surgery to 730 days after surgery
Secondary	Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value	The closer the ratio of the regenerated cartilage T2 value to the normal control cartilage T2 value is 1, it means that the regenerated cartilage The closer the water content and collagen arrangement are to normal cartilage.	At 24 months after surgery
Secondary	Change in ratio of regenerated cartilage ?R1 value to normal cartilage ?R1 value	The closer the ratio of the regenerated cartilage ?R1 value to the normal control cartilage ?R1 value is 1, it means that the GAG content of regenerated cartilage is closer to normal cartilage.	At 24 months after surgery