Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 3/16/2019 |
Start Date: | November 14, 2017 |
End Date: | November 2023 |
Contact: | Jonathan Elsner, PhD |
Email: | jelsner@regentis.co.il |
Phone: | 609 557 7412 |
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
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.
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.
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.
We found this trial at
13
sites
Altoona, Pennsylvania 16602
Principal Investigator: Robert J Singer, DO
Phone: 833-430-8686
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Bloomington, Minnesota 55431
Principal Investigator: Brad Nelson, MD
Phone: 833-430-8686
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Bozeman, Montana 59718
Principal Investigator: Timothy O'Brien, MD
Phone: 833-430-8686
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Chicago, Illinois 60612
Principal Investigator: Adam Yanke, MD
Phone: 833-430-8686
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Denver, Colorado 80210
Principal Investigator: Rachel Frank, MD
Phone: 833-430-8686
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Fort Lauderdale, Florida 33316
Principal Investigator: Kevin Shrock, MD
Phone: 833-430-8686
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La Mesa, California 91942
Principal Investigator: Scott Hacker, MD
Phone: 833-430-8686
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Orlando, Florida 32822
Principal Investigator: Sean McFadden, MD
Phone: 833-430-8686
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Salisbury, Maryland 21804
Principal Investigator: Jason Scopp, MD
Phone: 833-430-8686
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Savannah, Georgia 31405
Principal Investigator: David Palmer, MD
Phone: 833-430-8686
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