Regentis Biomaterials is conducting a pivotal FDA regulated clinical study (research study) to evaluate the safety and efficacy of an investigational device, GelrinC, implanted following a standard microfracture procedure, compared to a historical control group of patients who have undergone microfracture for the treatment of articular cartilage defects of the knee.
This is a non-randomized study, meaning that all patients who meet the eligibility criteria and volunteer to participate in the SAGE clinical study will receive GelrinC treatment.
What is GelrinC
In the clinical study, GelrinC will be used to fill a cartilage defect. It is intended to be resorbed by the body over time and be replaced by new tissue. GelrinC is composed of a synthetic material called PEG-DA and a structurally modified (denatured) protein called fibrinogen. These two materials have been used separately in medical products for other conditions, but in GelrinC are used together for cartilage repair.
GelrinC is approved for sale and marketing in the European community. It has been studied clinically in Europe in more than 50 patients and results suggested that GelrinC can provide substantial improvement in pain and function. The SAGE clinical study will further evaluate the potential benefits and the potential risks associated with GelrinC.
Additional Information on the Study
Because this is an FDA regulated clinical study, specific criteria must be followed to determine who is eligible for inclusion. A patient must meet all of these criteria to be included in the study. Final eligibility for the study will be determined by a study investigator (surgeon).
Are You a Candidate for the Study?
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If you are between 18 and 50 years old, are suffering from pain in only one knee and can provide informed consent, then you may be eligible for this study.
For more information, please contact Dr. Scott Hacker at 619-456-6012, email@example.com or visit www.gelrinc.com.
CAUTION: Investigational Device. Limited by Federal (USA) Law to Investigational Use.