A multicenter, randomized controlled trial comparing a single intra-articular injection of Gel-200, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee
Osteoarthritis and Cartilage
Volume 20, Issue 5
Hyaluronic Acid--therapeutic use; Osteoarthritis, Knee--drug therapy; Viscosupplements--therapeutic use
To compare the safety and efficacy of a single intra-articular (IA) injection of a new cross-linked hyaluronic acid product, Gel-200, with phosphate buffered saline (PBS, control) in a multi-center randomized controlled trial in patients with symptomatic osteoarthritis (OA) of the knee.
Patients were randomized 2:1 to receive a single injection of Gel-200 or PBS, after joint aspiration. The primary measure of effectiveness was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscores by 100-mm Visual Analog Scale (VAS); secondary outcomes included: total WOMAC, physical function, and stiffness subscores; patient and physician global assessments of disease activity, Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT–OARSI) strict responders, as well as safety of Gel-200.
Of 379 patients randomized, safety was evaluated in 377 and efficacy in 375 (98.9% randomized) in the intent-to-treat population. Effectiveness of Gel-200 by WOMAC pain subscores was statistically significant at week 13 (P = 0.037). Mean improvements from baseline in WOMAC pain subscores consistently favored Gel-200 at each visit. Effectiveness of Gel-200 treatment was statistically significant over weeks 3–13 by WOMAC total score, physical function, and physician global evaluations (P < 0.05). The number of “strict” OMERACT–OARSI responders was statistically significant from weeks 6 to 13 (P = 0.022). Adverse events were not significantly different between treatment groups, including serious adverse events considered related to study treatment.
This trial demonstrated that a single injection of Gel-200 was well tolerated and relieved pain associated with symptomatic OA of the knee over 13 weeks.
Trial registration number
ClinicalTrials.gov NTC 00449696.
Strand, V., Baraf, H.S.B., Lavin, P.T., Lim, S., Hosokawa, H. (2012). A multicenter, randomized controlled trial comparing a single intra-articular injection of Gel-200, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee. Osteoarthritis and Cartilage, 20(5), 350-356.