Gel-200 Versus Placebo in Osteoarthritis of the Knee

• Change From Baseline in WOMAC VAS Stiffness Subscore [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
  Observed WOMAC stiffness subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no stiffness; 100 mm meaning extreme stiffness. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
• Change From Baseline in WOMAC VAS Physical Function Subscore [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
  Observed WOMAC physical function subscore on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no difficulty; 100 mm meaning extreme difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
• Change From Baseline in WOMAC VAS Total Score [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
  Mean of all WOMAC pain, stiffness and physical function subscores on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning no pain, stiffness and difficulty; 100 mm meaning extreme pain, stiffness and difficulty. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
• Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT)- and the Osteoarthritis Research Society International (OARSI) Response [ Time Frame: Weeks 6 to 13 ] [ Designated as safety issue: No ]
  Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) strict responses defined by changes 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).
• Change From Baseline in Short Form - 36 (SF-36) [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
  Scored on physical component scale from 0 (negative health) to 100 (positive health). Calculated norm based with a mean of 50 and a standard deviation of 10.
• Change From Baseline in Subject Global Evaluations [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
  Observed subject evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
• Change From Baseline in Physician Global Evaluations [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
  Observed physician global evaluations on Visual Analog Scale (VAS) of 100 mm; 0 mm meaning excellent feeling in knee joint; 100 mm meaning poor feeling in knee joint. Change in score from baseline to week 13 was calculated as baseline minus week 13. Primary endpoint was the model estimated difference between Gel-200 and PBS placebo.
• Acetaminophen Consumption [ Time Frame: Weeks 9 to 13 (5 weeks) ] [ Designated as safety issue: No ]
  Weekly mean acetaminophen consumption between weeks 9 and 13.

• WOMAC VAS scores (Stiffness subscore, Physical Function subscore, Total WOMAC score)
• OMERACT-OARSI Response
• SF-36
• subject and physician global evaluations
• acetaminophen consumption

The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.

• Device: Gel-200
  Single intra-articular injection
• Device: Placebo
  Single intra-articular injection

• Experimental: Gel-200
  Intervention: Device: Gel-200
• Placebo Comparator: PBS
  Intervention: Device: Placebo

Inclusion Criteria:

• Subjects with a diagnosis of painful, symptomatic tibio-femoral osteoarthritis of the knee (Grade 1-3 on Kellgren - Lawrence (K-L) score).

Exclusion Criteria:

• Subjects with Grade 4 on K-L score
• Subjects with inflammatory diseases of the knee other than osteoarthritis such as rheumatoid arthritis
• Serious systemic diseases
• Female subjects who are pregnant or lactating