Clinical trial NCT03262909: Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Articular Cartilage Defects in the Knee Joint
Keywords: cartilage damage
cartilage defect
chondral lesion
osteochondral lesion
femur
condyle
Lead sponsor: Regentis Biomaterials
Sponsor class: INDUSTRY
First posted: 2017-08-25
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
timeFrame: 24 months post-surgery
measure: The change of physical pain as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
timeFrame: 24 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: Horizon Clinical Research
state: California
city: Orange
country: United States
facility: Hoag Orthopedics
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Fort Lauderdale
country: United States
facility: Shrock Clinical Research
state: Florida
city: Gulf Breeze
country: United States
facility: Andrews Institute
state: Florida
city: Orlando
country: United States
facility: Jewett Orthopaedic Clinic
state: Florida
city: Savannah
country: United States
facility: Optim Orthopedics
state: Georgia
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush
state: Illinois
city: Salisbury
country: United States
facility: Peninsula Orthopaedic Associates
state: Maryland
city: Bloomington
country: United States
facility: Tria Institute
state: Minnesota
city: Bozeman
country: United States
facility: Alpine Orthopedics
state: Montana
city: Altoona
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Morrisville
country: United States
facility: Mansfield Orthopedics
state: Vermont
Study officials:
References:
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.
citation: 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.
citation: 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.