Efficacy

This chart displays results from Brandt, et al., EfficacyEfficacy
Capacity for producing a desired result or effect and Safety of Intraarticular Sodium Hyaluronate in Knee OsteoarthritisOsteoarthritis
Arthritis typically with onset during middle or old age that is characterized by degenerative (gradual deterioration of joint) and sometimes abnormal growth in the bone and cartilage of one or more joints and a progressive wearing down of opposing joint surfaces with consequent distortion of joint position and is marked symptomatically especially by pain, swelling, and stiffness; abbreviation (OA)1. This prospective, multi-center, randomized, double-blind, controlled trial was conducted in 226 patients with knee osteoarthritis. Patients were randomized to three weekly injections of 30 mg sodium hyaluronate or physiologic salinePhysiologic Saline
An approximately 0.9 percent solution of sodium chloride; also called normal saline solution (control) and were observed for an additional 25 weeks.
In comparison with the control group, among patients who completed at least 15 weeks of the study and whose Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index pain score for the contralateralContralateral
Occurring on, affecting, or acting in conjunction with a part on the opposite side of the body knee was less than 12 at baseline, sodium hyaluronate injection resulted in improvement in WOMAC Index pain score, patient and investigator global assessments and pain on standing from Weeks 7 to 27.
Study results were as follows:
- 58% of the patients treated with sodium hyaluronate achieved a 5-unit or greater improvement in mean pain score from Weeks 7 through 27 (vs. control 40%)
- Nearly twice as many achieved a 7-unit or greater improvement (ORTHOVISC® 30% vs. control 17%)
The results indicate that sodium hyaluronate is well tolerated and produces statistically and clinically significant improvement of symptoms in patients with mild to moderate knee osteoarthritis in whom pain in the contralateral knee is relatively modest. In addition, alleviation of pain persisted for the entire duration of the study—27 Weeks.
