If you have knee pain caused by damaged articular cartilage and would like to be considered for the study, click here or call (833) 430-8686.
The SAGE Clinical Study is currently enrolling patients to assess the safety and efficacy of GelrinC for the treatment of articular cartilage damage in the knee. The SAGE study is a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study comparing GelrinC to microfracture, the current standard of care treatment for damaged knee cartilage. This multi-center Phase III pivotal study will enroll 120 patients. (NCT03262909)
GelrinC is composed of a synthetic material called polyethylene glycol (PEG) and a structurally modified form of human fibrinogen, a protein which in its native form assists healing processes. PEG and native human fibrinogen have been used individually in medical products for many years with excellent results.
This is a non-randomized study, so all patients who meet study requirements and agree to enter the study are provided GelrinC as treatment. Results will be compared to raw level historical microfracture data.
If you are 18-50 years old and have pain in only one knee, you may qualify. We are enrolling participants now at a medical facility near you. This is an FDA-regulated clinical study, and specific criteria must be followed to determine who is eligible for inclusion.
Symptoms of damaged knee cartilage include activity-related swelling and pain, and trouble doing things you enjoy because of the condition of your knee. If this sounds like you, or if you have been told by a doctor that your knee cartilage is damaged, please contact us about participating in our research study.
Limited space is available and not all types of damaged knee cartilage are suitable for this study.
How do I know if I am eligible for the SAGE clinical study?
FDA regulated clinical studies require specific criteria that must be followed to determine who is eligible for inclusion. A patient must meet all of these criteria to be included and only a surgeon can determine whether a patient is eligible. If you are between the ages of 18 and 50 years old and suffering from knee pain in only one knee, you may be eligible for this study. To find out whether you may be a candidate for this study, please click here or call (833) 430-8686.
What are the potential benefits?
If you are eligible and decide to voluntarily participate in the SAGE clinical study, you will receive GelrinC to fill your cartilage defect. You will also receive the follow-up care that goes with being part of a clinical study. By taking part in this study, there is a possibility that the newly formed tissue will be functionally better in the short and long term and that your symptoms may improve for a longer period of time in comparison to the standard of care, microfracture. The clinical study will evaluate whether GelrinC provides these potential benefits. Pain, other symptoms and your daily functioning may also improve as a result of the GelrinC procedure. The clinical study will evaluate whether GelrinC provides these potential benefits.
What are the potential risks and discomforts?
As with any orthopedic surgery, there are associated risks. The risks can be categorized as risks associated with anesthesia and knee surgery — which are typically present with any knee cartilage repair procedure — and risks potentially associated with the implantation of GelrinC. You will learn more about the potential risks and discomfort during the study screening and informed consent process.
Has GelrinC been studied in humans before?
Yes, GelrinC has been studied in a previous human pilot clinical study. The purpose of this study is to further evaluate the safety and efficacy (potential risks and benefits) of GelrinC in a larger number of patients.
What are the costs involved?
Participation in the SAGE clinical study should have no cost to the patient and may include the appropriate co-pay as per individual insurance coverage.