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

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ClinicalTrials.gov Identifier: NCT03262909
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Regentis Biomaterials

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 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 2021
Estimated Study Completion Date : November 2023

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.




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 ]


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.

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


Contacts
Contact: Jonathan Elsner, PhD 617-855-5566 jelsner@regentis.co.il
Contact: Ashley Maxwell amaxwell@regentis.co.il

Locations
United States, California
Horizon Clinical Research Recruiting
La Mesa, California, United States, 91942
Contact: Karen Mylerberg    833-430-8686      
Principal Investigator: Scott Hacker, MD         
United States, Florida
Shrock Clinical Research Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Natalie shrock    833-430-8686      
Principal Investigator: Kevin Shrock, MD         
Andrews Institute Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Mikala Childs         
Contact    833-430-8686      
Principal Investigator: Christopher O'Grady, MD         
United States, Georgia
Optim Orthopedics Recruiting
Savannah, Georgia, United States, 31405
Contact: Kelley Wiggins    833-430-8686      
Principal Investigator: David Palmer, MD         
United States, Illinois
Midwest Orthopaedics at Rush Recruiting
Chicago, Illinois, United States, 60612
Contact: Kavita Ahuja    833-430-8686      
Principal Investigator: Adam Yanke, MD         
Sub-Investigator: Brian J Cole, MD         
United States, Maryland
Peninsula Orthopaedic Associates Recruiting
Salisbury, Maryland, United States, 21804
Contact: Kelleigh Black    833-430-8686      
Principal Investigator: Jason Scopp, MD         
United States, Minnesota
Tria Institute Recruiting
Bloomington, Minnesota, United States, 55431
Contact: Kelsey Schnackenberg    833-430-8686      
Principal Investigator: Brad Nelson, MD         
Sub-Investigator: Jeffrey Macalena, MD         
Sub-Investigator: Marc Tompkins, MD         
United States, Montana
Alpine Orthopedics Recruiting
Bozeman, Montana, United States, 59718
Contact: Biz Bobowiec    833-430-8686      
Principal Investigator: Timothy O'Brien, MD         
United States, Pennsylvania
University Orthopedics Center Recruiting
Altoona, Pennsylvania, United States, 16602
Contact: Martina Snyder    833-430-8686      
Principal Investigator: Robert J Singer, DO         
United States, Texas
the San Antonio Orthopedics Group Recruiting
San Antonio, Texas, United States, 78229
Contact: Monica Contreras    833-430-8686      
Principal Investigator: Thomas DeBerardino, MD         
United States, Vermont
Mansfield Orthopedics Active, not recruiting
Morrisville, Vermont, United States, 05661
Sponsors and Collaborators
Regentis Biomaterials

Publications:
Responsible Party: Regentis Biomaterials
ClinicalTrials.gov Identifier: NCT03262909     History of Changes
Other Study ID Numbers: CLN-GR-01
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases