Advanced Cartilage Treatment With Injectable-hydrogel Validation of the Effect

NAUnknownINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

February 28, 2022

Primary Completion Date

October 31, 2024

Study Completion Date

October 31, 2024

Conditions
Cartilage Damage
Interventions
DEVICE

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.

Trial Locations (1)

3584 CX

RECRUITING

University Medical Center Utrecht, Utrecht

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Avania

INDUSTRY

collaborator

UMC Utrecht

OTHER

lead

Hy2Care BV

INDUSTRY