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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03262909

Acronym

SAGE

Enrollment

181

Registered

2017-08-25

Start date

2017-11-14

Completion date

2024-11-30

Last updated

2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Articular Cartilage Defects in the Knee Joint

Keywords

cartilage damage, cartilage defect, chondral lesion, osteochondral lesion, femur, condyle

Brief summary

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.

Interventions

DEVICEGelrinC

Patients will undergo GelrinC implantation.

OTHERMicrofracture historical control arm

Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).	24 months post-surgery
The change of physical pain as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).	24 months post-surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026