To test the hypothesis that tenidap has a structure-modifying effect in human knee osteoarthritis.
multicenter, prospective, randomized, double blind, 1 year duration.
primary painful knee osteoarthritis (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 piroxicam 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 Société Française d'Arthroscopie (SFA) score (0-100).
Patients (665) were randomized and 494 completed the study. After 1 year, intra-group radiological changes and radiological difference between both tenidap groups and the piroxicam group did not reach statistical significance. The intra-group arthroscopic deterioration of chondropathy was low, but statistically significant in the three study groups. However, there was no statistically significant difference between both tenidap groups and the piroxicam group.
This study failed to demonstrate any difference between the treatment arms with regard to the structural progression of medial knee osteoarthritis 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.