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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.
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.
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).
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. O'Brien,
call (833) 430-8686, or visit www.gelrinc.com.
CAUTION: Investigational Device. Limited by Federal (USA) Law to Investigational Use.
Since 1997, the physicians of Alpine Orthopedics and Sports Medicine have helped thousands of patients with orthopedic injuries and problems so they can better enjoy life, recreational opportunities, and sporting activities in Bozeman and the surrounding areas of southwest Montana. Schedule an appointment with one of our orthopedic surgeons or physical medicine and rehabilitation specialists today.
The Orthopedic Surgical Center of Montana is an outpatient, same-day, orthopedic surgical center in Bozeman, Montana serving the patients of Alpine Orthopedics. The Orthopedic Surgical Center of Montana is an independently owned surgical center, allowing better control over costs, billing, and patient access. Co-located with Alpine Orthopedics, our physicians can literally walk between the facilities, allowing them to be there when you are.