Description of Event or Problem · 1
LOCAL REACTION (KNEE); KNEE EFFUSION. A LITERATURE ARTICLE WAS RECEIVED IN AUG-2003 TITLED: CORTICOSTEROID COMPARED WITH HYALURONIC ACID INJECTIONS FOR THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE. THE ARTICLE DESCRIBES A PROSPECTIVE RANDOMIZED TRIAL THAT TESTED THE HYPOTHESIS THAT "THERE ARE NO SIGNIFICANT DIFFERENCES BETWEEN HYLAN G-F 20 (SYNVISC) AND THE CORTICOSTEROID BETAMETHASONE SODIUM PHOSPHATE-BETAMETHASONE ACETATE (CELESTONE SOLUSPAN) IN TERMS OF PAIN RELIEF OR IMPROVEMENT OF FUNCTION." IN THIS STUDY, ONE HUNDRED PTS WITH KNEE OSTEOARTHRITIS (OA) WERE RANDOMIZED TO RECEIVE EITHER HYLAN G-F 20 OR THE CORTICOSTEROID, AND THEN FOLLOWED FOR 6 MONTHS. THE PTS THAT WERE TREATED WITH HYLAN G-F 20 RECEIVED ONE COURSE OF 3 WEEKLY INJECTIONS. THIS REPORT INVOLVES ONE UNIDENTIFIED PT ENROLLED IN THE STUDY BETWEEN JULY 2000 AND JULY 2001 (EXACT DATE UNKNOWN) WITH A HISTORY OF RADIOGRAPHIC EVIDENCE OF SYMPTOMATIC OA OF THE KNEE, AND NO ALLERGY OR HYPERSENSITIVITY TO ANY OF THE STUDY MEDICATIONS, OR TO EGGS, FEATHERS, AVIAN PROTEINS, OR CHICKENS. IN THIS STUDY, SYMPTOMATIC OA IS DEFINED AS PAIN WITH WEIGHT-BEARING, AT THE TIBIOFEMORAL AND/OR THE PATELLOFEMORAL ARTICULATION TOGETHER WITH ONE OR MORE OF THE FOLLOWING RADIOGRAPHIC SIGNS AT THE PAINFUL ARTICULATION: LOSS OF CARTILAGE THICKNESS, OSTEOPHYTE FORMATION, SUBCHONDRAL SCLEROSIS, OR CYSTS. SYNVISC WAS ADMINISTERED TO THE PT'S KNEE (UNSPECIFIED AND DATE NOT PROVIDED) " IN ACCORDANCE WITH THE MFR'S RECOMMENDATIONS." WITHIN 24 HOURS OF SYNVISC INJECTIONS ( DATE AND NUMBER OF THE INJECTION WITHIN THE COURSE OF INJECTIONS NOT PROVIDED), THE PT DEVELOPED AN ACUTE LOCAL REACTION AND LARGE KNEE EFFUSION. THE PT WAS TREATED (DATE UNKNOWN) WITH ASPIRATION OF THE EFFUSION, WHICH REVEALED STRAW COLORED SYNOVIAL FLUID. THE PT WAS ALSO TREATED WITH ADMINISTRATION OF AN INTRA-ARTICULAR CORTICOSTEROID INJECTION, AND THE SYMPTOMS WERE RELIEVED (TIME FRAME NOT PROVIDED). THE ARTICLE INDICATED THAT NO INFECTIONS WERE PRESENT IN THIS SERIES.