Synvisc-One Clinical Summary
In a saline-controlled trial, Synvisc-One delivered superior pain relief up to 26 weeks.1
- Prospective, randomized, double-blind multicenter trial of 253 patients who had osteoarthritis of the knee confirmed via recent radiograph and were at least 40 years old.
- The primary end point was the difference between the groups in the change from baseline in patient-assessed pain as measured by the WOMAC A score (average of 5 questions) over 26 weeks.
- Patients were followed for 26 weeks. Study visits were scheduled for screening, baseline, and weeks 1, 4, 8, 12, 18 and 26.
- If patients had at least mild pain in the injected knee at the week 26 visit they were offered an injection of Synvisc-One and were followed for 4 weeks for repeat treatment safety.
- The primary endpoint for the study, the difference between the treatment groups in change from baseline over 26 weeks in the WOMAC A Pain Score was met.
- Synvisc-One also demonstrated superiority to saline control in multiple pre-defined secondary outcome measures, which included Patient Global Assessment over and at26 weeks, Clinical Observer Global Assessment over and at 26 weeks, and pain whilewalking on a flat surface (WOMAC A1) over and at 26 weeks.
Over 70% of patients responded to Synvisc-One2,3
Greater magnitude of pain relief with Synvisc-One vs. saline control2
- The frequency and type of adverse events (AEs) were similar between the Synvisc-One and saline control groups.
- There were no serious AEs in the injected knee in either the Synvisc-One or the saline control group. Device-related AEs involving the injected knee were mild or moderate in nature and were treated symptomatically.
|Patients with Device-Related Adverse Events in the Injected Knee|
|Any Device-Related Adverse Event||7 (5.7%)||4 (3.1%)|
|Arthralgia||2 (1.6%)||3 (2.3%)|
|Injection Site Pain||1 (0.8%)||1 (0.8%)|
|Joint Effusion||2 (1.6%)||0|
Note: Patients are counted once for each unique AE, and may have had more than one unique AE.
Repeat treatment safety1
- 160 patients were treated during this phase of the study, of which 77 patients received a second injection of Synvisc-One.
- Of these 77 patients, 5.2% experienced five device-related AEs in the injected knee. All were mild to moderate and were treated symptomatically.
- Patients who developed injected knee AEs during the initial phase of the study, and who subsequently received repeat treatment, did not experience injected knee AEs upon repeat exposure to Synvisc-One.