Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects
SAGE
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
1 other identifier
interventional
181
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2017
CompletedFirst Posted
Study publicly available on registry
August 25, 2017
CompletedStudy Start
First participant enrolled
November 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedMarch 22, 2022
March 1, 2022
5.4 years
August 17, 2017
March 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
GelrinC prospective treatment arm
EXPERIMENTALPatients will undergo GelrinC implantation.
Microfracture historical control arm
OTHERMicrofracture historical control arm
Interventions
Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Horizon Clinical Research
La Mesa, California, 91942, United States
Hoag Orthopedics
Orange, California, 92868, United States
University of Colorado
Denver, Colorado, 80222, United States
Shrock Clinical Research
Fort Lauderdale, Florida, 33316, United States
Andrews Institute
Gulf Breeze, Florida, 32561, United States
Jewett Orthopaedic Clinic
Orlando, Florida, 32822, United States
Optim Orthopedics
Savannah, Georgia, 31405, United States
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612, United States
Peninsula Orthopaedic Associates
Salisbury, Maryland, 21804, United States
Tria Institute
Bloomington, Minnesota, 55431, United States
Alpine Orthopedics
Bozeman, Montana, 59718, United States
University Orthopedics Center
Altoona, Pennsylvania, 16602, United States
Mansfield Orthopedics
Morrisville, Vermont, 05661, United States
Related Publications (3)
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.
PMID: 26187572BACKGROUNDBerdichevski 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.
PMID: 25542788BACKGROUNDShah SS, Lee S, Mithoefer K. Next-Generation Marrow Stimulation Technology for Cartilage Repair: Basic Science to Clinical Application. JBJS Rev. 2021 Jan 19;9(1):e20.00090. doi: 10.2106/JBJS.RVW.20.00090.
PMID: 33512974DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2017
First Posted
August 25, 2017
Study Start
November 14, 2017
Primary Completion
April 1, 2023
Study Completion
November 1, 2024
Last Updated
March 22, 2022
Record last verified: 2022-03