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Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects (SAGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03262909
Recruitment Status : Active, not recruiting
First Posted : August 25, 2017
Last Update Posted : March 22, 2022
Sponsor:
Information provided by (Responsible Party):
Regentis Biomaterials

Study Description
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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.

Condition or disease Intervention/treatment Phase
Articular Cartilage Defects in the Knee Joint Device: GelrinC Other: Microfracture historical control arm Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 181 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 14, 2017
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : November 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: GelrinC prospective treatment arm
Patients will undergo GelrinC implantation.
 Device: GelrinC
Patients will undergo GelrinC implantation.
Microfracture historical control arm
Microfracture historical control arm
 Other: Microfracture historical control arm
Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.


Outcome Measures
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Primary Outcome Measures :
  1. The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS). [ Time Frame: 24 months post-surgery ]
  2. The change of physical pain as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS). [ Time Frame: 24 months post-surgery ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262909


Locations
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United States, California
Horizon Clinical Research
La Mesa, California, United States, 91942
Hoag Orthopedics
Orange, California, United States, 92868
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80222
United States, Florida
Shrock Clinical Research
Fort Lauderdale, Florida, United States, 33316
Andrews Institute
Gulf Breeze, Florida, United States, 32561
Jewett Orthopaedic Clinic
Orlando, Florida, United States, 32822
United States, Georgia
Optim Orthopedics
Savannah, Georgia, United States, 31405
United States, Illinois
Midwest Orthopaedics at Rush
Chicago, Illinois, United States, 60612
United States, Maryland
Peninsula Orthopaedic Associates
Salisbury, Maryland, United States, 21804
United States, Minnesota
Tria Institute
Bloomington, Minnesota, United States, 55431
United States, Montana
Alpine Orthopedics
Bozeman, Montana, United States, 59718
United States, Pennsylvania
University Orthopedics Center
Altoona, Pennsylvania, United States, 16602
United States, Vermont
Mansfield Orthopedics
Morrisville, Vermont, United States, 05661
Sponsors and Collaborators
Regentis Biomaterials
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Regentis Biomaterials
ClinicalTrials.gov Identifier: NCT03262909    
Other Study ID Numbers: CLN-GR-01
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: March 22, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Regentis Biomaterials:
cartilage damage
cartilage defect
chondral lesion
 osteochondral lesion
femur
condyle
Additional relevant MeSH terms:
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Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases