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

Regentis Biomaterials

Status

Active, not recruiting

Conditions

Articular Cartilage Defects in the Knee Joint

Treatments

Other: Microfracture historical control arm

Device: GelrinC

Study type

Interventional

Funder types

Industry

Identifiers

NCT03262909

CLN-GR-01

Details and patient eligibility

About

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.

Enrollment

181 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.