Guided Cartilage Regeneration Membrane

Not Applicable

• Conditions: Articular Cartilage Injury; Knee Ligament Injury
• Interventions: Combination Product: Guided cartilage regeneration membrane; Procedure: Microfracture

• Registration Number: NCT04463238
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-03
• Study First Submitted QC: 2020-07-03
• Last Update Submitted: 2020-07-03
• Study First Posted: 2020-07-09
• Last Update Posted: 2020-07-09
• Study Start: 2020-08-03
• Primary Completion: 2022-08-03
• Study Completion: 2023-08-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cartilage membrane surgery	Microfracture	The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd. Cartilage regeneration membrane combined with microfracture surgery.
Microfracture	Microfracture	The control group was treated with microfractures widely recognized at home and abroad.
Cartilage membrane surgery	Guided cartilage regeneration membrane	The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd. Cartilage regeneration membrane combined with microfracture surgery.

Primary Outcome Measures

Name	Time	Method
MRI evaluation of articular cartilage injury 730 days (2 years) after repair	End of surgery to 730 days after surgery	The nuclear magnetic evaluation indicators are as follows: 1. Cartilage defect repair filling degree; 2. Fusion of repair tissue and adjacent normal cartilage; 3. Repair tissue surface structure; 4. 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.

Secondary Outcome Measures

Name	Time	Method
Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value	At 24 months after surgery	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.
Change in ratio of regenerated cartilage △R1 value to normal cartilage △R1 value	At 24 months after surgery	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.

Trial Locations

Locations (8)

Zhongnan Hospital; 🇨🇳 Wuhan, Hubei, China

Second Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China

Xi'an Honghui Hospital; 🇨🇳 Xi'an, Shanxi, China

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China

The First Affiliated Hospital of Kunming Medical College; 🇨🇳 Kunming, Yunnan, China

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing Municipality, China

Zunyi Medical College; 🇨🇳 Zunyi, Guizhou, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China