Pivotal study: Wobig et al.1,3,a
aN=109 (3 weekly, 2-mL injections SYNVISC [n=52] or saline [n=57]). The most commonly reported device-related adverse events (AEs) were transient pain, swelling, and joint effusion in the injected knee.
bN=109 (3 weekly 2-mL injections SYNVISC [n=52] or saline [n=57]). Week 26 mean improvement from baseline for weight-bearing pain evaluated by patients: 34 mm (SYNVISC) and 19.1 mm (saline).2 Week 26 data based on patient telephone interviews.
Pivotal study: Chevalier et al.2,4,b
bN=253 (6 mL of Synvisc-One® + arthrocentesis=124; 6 mL of phosphate-buffered saline placebo + arthrocentesis=129). The most commonly reported device-related AEs were pain in the target knee (coded as “arthralgia”), joint stiffness, joint effusion, arthritis, arthropathy, injection site pain, and joint swelling.
WOMAC=Western Ontario & McMaster Universities Osteoarthritis Index. WOMAC is an instrument used to assess changes in OA symptoms, with each question graded on a 5-point scale (0=low, 4=high).
In a head-to-head clinical trial conducted independently of industry, SYNVISC provided significantly greater improvement in OA knee pain from baseline versus Hyalgan at 6 months (intergroup difference: 2.5 cm, P=0.02).5,*
SYNVISC provided greater patient satisfaction with treatment versus Hyalgan at 6 months (7.9 vs 5.0 on a VAS, respectively) in a head-to-head study.5
Treatment-related AEs were similar between the 2 groups (SYNVISC, n=39; sodium hyaluronate, n=30).5
Raman et al.5,c
*N=392 (SYNVISC=199, Hyalgan=193). Study compared clinical effectiveness, functional outcome, and patient satisfaction following intra-articular injection with hylan G-F 20 and sodium hyaluronate in patients with symptomatic primary OA of the knee. Primary endpoint and results: Intergroup difference in knee pain as measured by the unblinded patient on 10-cm VAS (0-10, 10 as worst pain) at 6 months (2.5 cm, deduced from values represented in Figure 1). Secondary endpoints were WOMAC 3.1 (Likert) and Oxford knee scores. Patient satisfaction was quantified on VAS. Safety: All minor AEs were related to the treated knee, and no systemic AEs were recorded in either group. Study limitations: Number of injections in each group (3 for SYNVISC, 5 for Hyalgan) is a source of treatment bias. Additionally, 2 saline injections in the SYNVISC group were not included due to unknown effect on final outcome. Thus, patients were not blinded to the treatment. Preferred management strategy of OA treatment for individual clinicians was not altered. At 6 months, 8.6% of SYNVISC patients violated study protocol by taking NSAIDs, compared with 18.5% of Hyalgan patients.
SYNVISC provided significantly greater, longer-lasting relief of OA knee pain versus a long-acting corticosteroid (TH) in a head-to-head superiority trial.6
Overall incidence of AEs or of any single AE was similar between the 2 groups. Common AEs included arthralgia, swelling, pain, and stiffness. No serious AEs were reported in the SYNVISC group. (SYNVISC, 21%; TH, 14%).6
Caborn et al.6,d
dN=218 (SYNVISC=113, TH=105; ITT population). Study was a prospective, multicenter, randomized, single-blind, parallel-group clinical trial. The goal was to compare the efficacy and tolerability of a course of hylan G-F 20 therapy to a typical course of TH therapy. Primary endpoints: Question A1 of the WOMAC (pain while walking on a flat surface).
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