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

Articular Cartilage Defects in the Knee Joint Clinical Trial

— SAGE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03262909
• Other study ID #: CLN-GR-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 14, 2017
• Est. completion date: November 2024

Study information

• Verified date: March 2022
• Source: Regentis Biomaterials
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 181
• Est. completion date: November 2024
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Articular Cartilage Defects in the Knee Joint
• Cartilage Diseases

Intervention

Device:
• GelrinC
Patients will undergo GelrinC implantation.

Other:
• Microfracture historical control arm
Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.

Locations

Country	Name	City	State
United States	University Orthopedics Center	Altoona	Pennsylvania
United States	Tria Institute	Bloomington	Minnesota
United States	Alpine Orthopedics	Bozeman	Montana
United States	Midwest Orthopaedics at Rush	Chicago	Illinois
United States	University of Colorado	Denver	Colorado
United States	Shrock Clinical Research	Fort Lauderdale	Florida
United States	Andrews Institute	Gulf Breeze	Florida
United States	Horizon Clinical Research	La Mesa	California
United States	Mansfield Orthopedics	Morrisville	Vermont
United States	Hoag Orthopedics	Orange	California
United States	Jewett Orthopaedic Clinic	Orlando	Florida
United States	Peninsula Orthopaedic Associates	Salisbury	Maryland
United States	Optim Orthopedics	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Regentis Biomaterials

Country where clinical trial is conducted

United States, 

References & Publications (2)

Berdichevski A, Shachaf Y, Wechsler R, Seliktar D. Protein composition alters in vivo resorption of PEG-based hydrogels as monitored by contrast-enhanced MRI. Biomaterials. 2015 Feb;42:1-10. doi: 10.1016/j.biomaterials.2014.11.015. Epub 2014 Dec 9. — View Citation

Trattnig S, Ohel K, Mlynarik V, Juras V, Zbyn S, Korner A. Morphological and compositional monitoring of a new cell-free cartilage repair hydrogel technology - GelrinC by MR using semi-quantitative MOCART scoring and quantitative T2 index and new zonal T2 index calculation. Osteoarthritis Cartilage. 2015 Dec;23(12):2224-2232. doi: 10.1016/j.joca.2015.07.007. Epub 2015 Jul 14. — View Citation

Outcome

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