Oral cetylated fatty acid for the improvement of function, quality of life, and pain in patients with moderate to severe knee osteoarthritis

INTERVENTION: Celadrin® (oral cetylated fatty acid) 1720 mg per day or placebo. CONDITION: Osteoarthritis of the knee ; Musculoskeletal Diseases ; Arthropathies PRIMARY OUTCOME: Six‐minute timed walk, assessed at baseline, 2, 4 and 8 weeks. SECONDARY OUTCOME: The following were assessed at baseline, 2, 4 and 8 weeks: ; 1. Pain Visual Analogue Scale (VAS); 2. ?Timed up and go? test; 3. Unilateral anterior reach; 4. Western Ontario and McMasters Universities Osteoarthritic (WOMAC) index; 5. Lequesne Algofunctional Index (LAI); 6. ROM INCLUSION CRITERIA: 1. Diagnosis of moderate to severe osteoarthritis of the knee by American College of Rheumatology (ACR) clinical criteria (95% sensitive and 69% specific) 2. Pain in the knee 3. At least three of the following: 3.1. Age greater than or equal to 40 (note ‐ original ACR Criteria call for age greater than 50) 3.2. Morning stiffness lasting 30 minutes or less 3.3. Demonstration of crepitus during knee Range Of Motion (ROM) 3.4. Bony tenderness 3.5. Bony enlargement 3.6. No palpable warmth 4. Presence of knee pain greater than six months 5. Presence of knee pain for at least 10 days in the previous month 6. Subjects agree to stop all pain medications 7. Baby aspirin (81 mg) is allowed 8. Subject agrees to all study visits 9. Females of child bearing potential must agree to use appropriate birth control methods during the active study 10. Must agree not to initiate any new exercise or diet program during the study 11. Must a