Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects

Status:	Recruiting
Healthy:	No
Age Range:	18 - 50
Updated:	3/16/2019
Start Date:	November 14, 2017
End Date:	November 2023
Contact:	Jonathan Elsner, PhD
Email:	jelsner@regentis.co.il
Phone:	609 557 7412

A Prospective, Open-Label, Multicenter Pivotal Study to Evaluate the Safety and Efficacy of GelrinC® for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle: A Comparison to Historical Control Microfracture

Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective
treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a
historical control arm (microfracture) in the treatment of cartilage defects in the knee.

Main Inclusion Criteria:

- Age between 18 and 50.

- Single contained symptomatic lesion located on the femoral condyle of the femur graded
as ICRS III or IV with less than 5 mm of bone loss below the subchondral plate.

- Lesion size between 1 and 5 cm2 post debridement, less than or equal to 2.5 cm in
diameter.

- BMI ≤35

- Contralateral knee is asymptomatic, stable, fully functional and not medically
treated.

Main Exclusion Criteria:

- Presence of an additional grade III or IV symptomatic lesion.

- Recent Osteochondritis Dissecans within 1 year of baseline visit.

- Untreated ACL and/or PCL deficiency or Complex ligamentous instability of the knee.

- Patient is excluded if presenting untreated current meniscal tear or if previous
menisci resection was within the last 6 months.

- Previous tendon repair or ligament reconstruction within the last 6 months.

- Failed Mosaicplasty or ACI or MACI or any other cartilage repair product.

- Microfracture performed less than 1 year before baseline visit.

We found this trial at

sites

Optim Orthopedics

Savannah, Georgia 31405

Principal Investigator: David Palmer, MD

Phone: 833-430-8686

from

Savannah, GA