Gel-200 Extension and Open-Label Study in Osteoarthritis of the Knee

Improvement From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (Pain Subscore)

Observed WOMAC pain subscore on VAS of 100 mm.; 0 mm meaning no pain; 100 mm meaning extreme pain. Improved score from baseline to week 13 were calculated as baseline minus week 13.

Time frame: Baseline and Week 13

Improvement From Baseline in WOMAC VAS (Stiffness Subscore)

Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Improved score from baseline to week 13 were calculated as baseline minus week 13.

Time frame: Baseline and Week 13

Improvement From Baseline in WOMAC VAS (Physical Function Subscore)

Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Improved score from baseline to week 13 were calculated as baseline minus week 13.

Time frame: Baseline and Week 13

Improvement From Baseline in WOMAC VAS (Total Score)

Observed all WOMAC mean scores on Visual Analog Scale (VAS) of 100 mm; a total of WOMAC pain, stiffness, and physical function subscores. Improved score from baseline to week 13 were calculated as baseline minus week 13.

Time frame: Baseline and Week 13

Outcome Measures in Rheumatology Artthritis Clinical Trials (OMERACT) - and the Osteoarthritis Research Society International (OARSI) Response

Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by improvements from baseline in WOMAC pain or physical function subscore ≥50% with absolute changes ≥20 mm (termed strict responders), or ≥20% with absolute changes ≥10mm in 2 of 3 measures of WOMAC pain or physical function subscore or subject global evaluations (termed responders).