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

Not Applicable

Active, not recruiting

• Conditions: Articular Cartilage Defects in the Knee Joint
• Interventions: Other: Microfracture historical control arm; Device: GelrinC

• Registration Number: NCT03262909
• Lead Sponsor: Regentis Biomaterials

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-25
• Study Start: 2017-11-14
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-20
• Last Update Posted: 2022-03-22
• Primary Completion: 2023-04
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 181

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microfracture historical control arm	Microfracture historical control arm	Microfracture historical control arm
GelrinC prospective treatment arm	GelrinC	Patients will undergo GelrinC implantation.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

Alpine Orthopedics; 🇺🇸 Bozeman, Montana, United States

Tria Institute; 🇺🇸 Bloomington, Minnesota, United States

Horizon Clinical Research; 🇺🇸 La Mesa, California, United States

Hoag Orthopedics; 🇺🇸 Orange, California, United States

Optim Orthopedics; 🇺🇸 Savannah, Georgia, United States

Peninsula Orthopaedic Associates; 🇺🇸 Salisbury, Maryland, United States

University Orthopedics Center; 🇺🇸 Altoona, Pennsylvania, United States

Mansfield Orthopedics; 🇺🇸 Morrisville, Vermont, United States

University of Colorado; 🇺🇸 Denver, Colorado, United States

Jewett Orthopaedic Clinic; 🇺🇸 Orlando, Florida, United States

Midwest Orthopaedics at Rush; 🇺🇸 Chicago, Illinois, United States

Shrock Clinical Research; 🇺🇸 Fort Lauderdale, Florida, United States

Andrews Institute; 🇺🇸 Gulf Breeze, Florida, United States