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We finished two trials in 2009.
One was the Monovisc trial where patients had a 50/50 chance of receiving a new single viscosupplement injection to the knee (current medications available by prescrition consist of three injections administered one week apart). Patients then had the option of getting an injection of the product itself 6 months into the trial. Patients did very well in the trial. We were an add-on site for the study and still reached our target enrollment and had a 95% retension rate. The product is still under FDA review.
We also closed our Supartz Shoulder Trail. In this trial patients had a 50/50 chance of receiving the viscosupplement Supartz, which is an FDA approved product, currently only approved for the knee, to their shoulder. The patients also had the option of receiving repeat injections of Supartz 6 months into the study if needed. We were a top enrolling site for the study and all patients completed the study. Supartz is under review to be FDA approved for use in the shoulder.
We are continuing to perform an ongoing Pfizer trial of the antiinflammatory Celebrex compared to other prescriptive antiinflammatories. It is a 6 month study where patients are stratified to receive Celebrex or any other prescriptive antiinflammatory Dr. Plancher chooses. It is a phase 4 study, which is for medications which are already on the market and are required by the FDA to submit continued safety and efficacy data.
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To Learn More About Us
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Kevin D. Plancher, MD Chairman
Richard Berman
Donna deVarona
Duane Hill
George Kollitides
Albert Nickel
Jon Scott
Morton Seaman
Suzanne Smith
Mary Travers 1936-2009
Janine D. Bahar, Executive Director
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