Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects
NCT ID: NCT03262909
Last Updated: 2022-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
181 participants
INTERVENTIONAL
2017-11-14
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GelrinC prospective treatment arm
Patients will undergo GelrinC implantation.
GelrinC
Patients will undergo GelrinC implantation.
Microfracture historical control arm
Microfracture historical control arm
Microfracture historical control arm
Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.
Interventions
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GelrinC
Patients will undergo GelrinC implantation.
Microfracture historical control arm
Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Regentis Biomaterials
INDUSTRY
Responsible Party
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Locations
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Horizon Clinical Research
La Mesa, California, United States
Hoag Orthopedics
Orange, California, United States
University of Colorado
Denver, Colorado, United States
Shrock Clinical Research
Fort Lauderdale, Florida, United States
Andrews Institute
Gulf Breeze, Florida, United States
Jewett Orthopaedic Clinic
Orlando, Florida, United States
Optim Orthopedics
Savannah, Georgia, United States
Midwest Orthopaedics at Rush
Chicago, Illinois, United States
Peninsula Orthopaedic Associates
Salisbury, Maryland, United States
Tria Institute
Bloomington, Minnesota, United States
Alpine Orthopedics
Bozeman, Montana, United States
University Orthopedics Center
Altoona, Pennsylvania, United States
Mansfield Orthopedics
Morrisville, Vermont, United States
Countries
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References
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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.
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.
Shah 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.
Other Identifiers
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CLN-GR-01
Identifier Type: -
Identifier Source: org_study_id
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