50
Participants
Start Date
February 28, 2022
Primary Completion Date
October 31, 2024
Study Completion Date
October 31, 2024
Injectable Hydrogel treatment
The Injectable Hydrogel is a single use two-component injectable and bioresorbable hydrogel intended for treatment of cartilage defects in the knee, it is a medical device, exclusively for clinical investigations. The hydrogel is mixed intraoperatively and with an open knee procedure inserted into the cartilage defect, where it crosslinks and adheres to the cartilage with the use of a primer, allowing it to stay in place during movements of the knee. The hydrogel covers the defect to prevent formation of scar tissue and to allow cartilage to regenerate. The Injectable Hydrogel will be used in combination with general instruments typically used. The different components of the Injectable Hydrogel are arranged in two boxes: Components of the Injectable Hydrogel are grouped in plastic cover bags or packaged in vial boxes.This is a performance study, with a single arm, i.e Injectable Hydrogel. Recovery is monitored.
RECRUITING
University Medical Center Utrecht, Utrecht
Collaborators (1)
Avania
INDUSTRY
UMC Utrecht
OTHER
Hy2Care BV
INDUSTRY