NCT04463238

Guided Cartilage Regeneration Membrane

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Articular Cartilage Injury
• Knee Ligament Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-03
• Primary completion: 2022-08-03
• Completion: 2023-08-03
• First posted: 2020-07-09
• Last updated: 2020-07-09

Locations

8 sites across 1 country: China