Arthroscopic evaluation of potential structure-modifying XXXX . A multicenter, randomized, double-blind comparison of tenidap sodium vs @entity5230 .

@entity1 @entity626 @entity5230 @entity5122 @entity10194 @entity158
OBJECTIVE: To test the hypothesis that tenidap has a structure-modifying effect in @entity1 @entity626 . DESIGN:                 <AbstractText Label="STUDY" NlmCategory="METHODS">multicenter, prospective, randomized, double blind, 1 year duration. @entity1 : primary @entity158 (ACR criteria) of the medial tibiofemoral compartment, medial joint space width > or =2mm, at least 10% of one cartilage surface of the medial compartment affected by superficial fibrillation or worse at baseline arthroscopy. STUDY MEDICATION: once daily dosage of either tenidap 40 mg, tenidap 120 mg or @entity5230 20mg. STUDY ENDPOINTS: bilateral extended weight-bearing X-rays and knee arthroscopy under local anaesthesia were done at entry and after 1 year. Joint space width was measured in millimeters at the narrowest point of the medial compartment. Chondropathy was scored by using reader's overall assessment (VAS score, 100mm) and Soci  t   Fran  aise d'Arthroscopie ( @entity10194 ) score (0-100). RESULTS: @entity1 (665) were randomized and 494 completed the study. After 1 year, intra-group radiological changes and radiological difference between both tenidap groups and the @entity5230 group did not reach statistical significance. The intra-group arthroscopic @entity5122 was low, but statistically significant in the three study groups. However, there was no statistically significant difference between both tenidap groups and the @entity5230 group. CONCLUSIONS: This study failed to demonstrate any difference between the treatment arms with regard to the structural progression of medial @entity626 as measured by radiography and arthroscopy. Arthroscopy did, however, appears to be more sensitive in detecting disease progression than the weight-bearing radiographs with fully extended knees. This study shows that it is possible to complete a large international trial using arthroscopy as an outcome measure of articular cartilage.
