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

March 20, 2022 updated by: Regentis Biomaterials

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

181

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GelrinC prospective treatment arm
Patients will undergo GelrinC implantation.
Device: GelrinC
Patients will undergo GelrinC implantation.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
24 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regentis Biomaterials

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2017

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

August 17, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 20, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-GR-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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