Guided Cartilage Regeneration Membrane (GCRM)

Peking University

Status: Unknown

Conditions: Articular Cartilage Injury; Knee Ligament Injury

Treatments: Combination Product: Guided cartilage regeneration membrane; Procedure: Microfracture

Study type: Interventional

Funder types: Other

Identifiers

NCT04463238

2015035

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Cartilage membrane surgery

Experimental group

Description:

The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd. Cartilage regeneration membrane combined with microfracture surgery.

Treatment:

Combination Product: Guided cartilage regeneration membrane

Procedure: Microfracture

Microfracture

Other group

Description:

The control group was treated with microfractures widely recognized at home and abroad.

Treatment:

Procedure: Microfracture