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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GelrinC prospective treatment arm | Experimental | Patients will undergo GelrinC implantation. |
|
| Microfracture historical control arm | Other | Microfracture historical control arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GelrinC | Device | Patients will undergo GelrinC implantation. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horizon Clinical Research | La Mesa | California | 91942 | United States | ||
| Hoag Orthopedics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26187572 | Background | 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. | |
| 25542788 |
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| Microfracture historical control arm |
| Other |
Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure. |
|
| 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 |
| Background |
| 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. |
| 33512974 | Derived | 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. |