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

Primary Purpose

Articular Cartilage Defects in the Knee Joint

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GelrinC
Microfracture historical control arm
Sponsored by
Regentis Biomaterials
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Articular Cartilage Defects in the Knee Joint focused on measuring cartilage damage, cartilage defect, chondral lesion, osteochondral lesion, femur, condyle

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Horizon Clinical Research
  • Hoag Orthopedics
  • University of Colorado
  • Shrock Clinical Research
  • Andrews Institute
  • Jewett Orthopaedic Clinic
  • Optim Orthopedics
  • Midwest Orthopaedics at Rush
  • Peninsula Orthopaedic Associates
  • Tria Institute
  • Alpine Orthopedics
  • University Orthopedics Center
  • Mansfield Orthopedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

GelrinC prospective treatment arm

Microfracture historical control arm

Arm Description

Patients will undergo GelrinC implantation.

Microfracture historical control arm

Outcomes

Primary Outcome Measures

The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
The change of physical pain as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).

Secondary Outcome Measures

Full Information

First Posted
August 17, 2017
Last Updated
March 20, 2022
Sponsor
Regentis Biomaterials
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1. Study Identification

Unique Protocol Identification Number
NCT03262909
Brief Title
Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects
Acronym
SAGE
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regentis Biomaterials

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular Cartilage Defects in the Knee Joint
Keywords
cartilage damage, cartilage defect, chondral lesion, osteochondral lesion, femur, condyle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
181 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GelrinC prospective treatment arm
Arm Type
Experimental
Arm Description
Patients will undergo GelrinC implantation.
Arm Title
Microfracture historical control arm
Arm Type
Other
Arm Description
Microfracture historical control arm
Intervention Type
Device
Intervention Name(s)
GelrinC
Intervention Description
Patients will undergo GelrinC implantation.
Intervention Type
Other
Intervention Name(s)
Microfracture historical control arm
Intervention Description
Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.
Primary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Horizon Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Hoag Orthopedics
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
Facility Name
Shrock Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Andrews Institute
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Jewett Orthopaedic Clinic
City
Orlando
State/Province
Florida
ZIP/Postal Code
32822
Country
United States
Facility Name
Optim Orthopedics
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Midwest Orthopaedics at Rush
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Peninsula Orthopaedic Associates
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Facility Name
Tria Institute
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Alpine Orthopedics
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
University Orthopedics Center
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Mansfield Orthopedics
City
Morrisville
State/Province
Vermont
ZIP/Postal Code
05661
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26187572
Citation
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.
Results Reference
background
PubMed Identifier
25542788
Citation
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.
Results Reference
background
PubMed Identifier
33512974
Citation
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.
Results Reference
derived

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

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