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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

Tracking Information
First Submitted Date  ICMJE August 17, 2017
First Posted Date  ICMJE August 25, 2017
Last Update Posted Date March 22, 2022
Actual Study Start Date  ICMJE November 14, 2017
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2017)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Articular Cartilage Defects in the Knee Joint
Intervention  ICMJE
  • Device: GelrinC
    Patients will undergo GelrinC implantation.
  • Other: Microfracture historical control arm
    Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.
Study Arms  ICMJE
  • Experimental: GelrinC prospective treatment arm
    Patients will undergo GelrinC implantation.
    Intervention: Device: GelrinC
  • Microfracture historical control arm
    Microfracture historical control arm
    Intervention: Other: Microfracture historical control arm
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2017)
181
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2024
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03262909
Other Study ID Numbers  ICMJE CLN-GR-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Regentis Biomaterials
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Regentis Biomaterials
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Regentis Biomaterials
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP