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Cartilage Repair
GelrinC for Cartilage Defects (SAGE Trial)
N/A
Waitlist Available
Research Sponsored by Regentis Biomaterials
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Lesion size between 1 and 5 cm2 post debridement, less than or equal to 2.5 cm in diameter.
Contralateral knee is asymptomatic, stable, fully functional and not medically treated.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post-surgery
Awards & highlights
SAGE Trial Summary
This trial compares the effectiveness and safety of two treatments for cartilage defects in the knee. One treatment is GelrinC, and the other is microfracture.
Who is the study for?
This trial is for adults aged 18-50 with a Body Mass Index (BMI) of 35 or less, who have a specific type of knee cartilage damage (ICRS III or IV) that's no larger than 5 cm2 and not deeper than 5 mm. The other knee must be healthy. People with additional severe lesions, recent bone conditions, untreated ligament issues, recent meniscus surgery, or past failed cartilage treatments can't join.Check my eligibility
What is being tested?
The study tests GelrinC against an older method called microfracture in treating knee cartilage defects. It's conducted at multiple centers where patients are openly assigned to either the new treatment arm (GelrinC) or compared to historical data from the control group.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include pain at the injection site, swelling in the treated knee, infection risk due to surgery and possible adverse reactions to GelrinC material.
SAGE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My wound is between 1 and 5 cm2 and no wider than 2.5 cm after cleaning.
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My other knee is healthy and works well without any medical treatment.
Select...
I have a severe knee injury with minimal bone loss.
Select...
I have a severe knee injury with minimal bone loss.
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I am between 18 and 50 years old.
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My other knee is healthy, stable, and hasn't needed medical treatment.
Select...
My wound is between 1 and 5 cm2 after cleaning, no wider than 2.5 cm.
Select...
I am between 18 and 50 years old.
SAGE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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).
SAGE Trial Design
2Treatment groups
Experimental Treatment
Group I: Microfracture historical control armExperimental Treatment1 Intervention
Microfracture historical control arm
Group II: GelrinC prospective treatment armExperimental Treatment1 Intervention
Patients will undergo GelrinC implantation.
Find a Location
Who is running the clinical trial?
Regentis BiomaterialsLead Sponsor
1 Previous Clinical Trials
56 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My wound is between 1 and 5 cm2 and no wider than 2.5 cm after cleaning.My other knee is healthy and works well without any medical treatment.I have a severe symptom-causing lesion.I had a microfracture surgery less than a year ago.I have an untreated ACL or PCL injury or my knee is very unstable.I have a severe knee injury with minimal bone loss.I have a severe knee injury with minimal bone loss.I was diagnosed with Osteochondritis Dissecans less than a year ago.I have had a previous cartilage repair treatment that did not work.I had tendon or ligament surgery in the last 6 months.I am between 18 and 50 years old.I have not had a recent meniscus surgery or untreated tear.My other knee is healthy, stable, and hasn't needed medical treatment.My wound is between 1 and 5 cm2 after cleaning, no wider than 2.5 cm.I am between 18 and 50 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Microfracture historical control arm
- Group 2: GelrinC prospective treatment arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age limitation for this medical trial allow individuals aged 45 and below to participate?
"As per the study's requirements, participants must be between 18-50 years old to qualify for enrollment."
Answered by AI
Is recruitment for this research initiative still ongoing?
"As evidenced from clinicaltrials.gov, this medical trial is not currently recruiting test participants; the initial post date was November 14th 2017 and it has been updated as recently as March 20th 2022. Nevertheless, there are 11 other studies actively enrolling patients at present time."
Answered by AI
Is there an opportunity to become a participant in this research study?
"Aspiring participants must possess a diagnosis of chondromalacia and be between 18-50 years old to partake in this medical trial. 181 people are anticipated to enrol."
Answered by AI
How many healthcare facilities are presently engaged in this research?
"Mansfield Orthopedics in Morrisville, Hoag Orthopedics in Orange, and Horizon Clinical Research in La Mesa are amongst the numerous research sites running this trial. In total, 13 medical centres participate."
Answered by AI
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