In a saline-controlled trial, Synvisc-One delivered superior pain relief over 26 weeks.1
Study design
- 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.
Efficacy results1
- 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 at 26 weeks, Clinical Observer Global Assessment over and at 26 weeks, and pain while walking on a flat surface (WOMAC A1) over and at 26 weeks.
Over 70% of patients responded to Synvisc-One2,3
Walking pain response rates
Greater magnitude of pain relief with Synvisc-One vs. saline control2
Walking pain relief
Adverse events1
- 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 | ||
|---|---|---|
|
Synvisc-One N=123 n (%) |
Saline Control N=130 n (%) |
|
| Any Device-Related Adverse Event | 7 (5.7%) | 4 (3.1%) |
| Arthralgia | 2 (1.6%) | 3 (2.3%) |
| Arthritis | 1 (0.8%) | 0 |
| Arthropathy | 1 (0.8%) | 0 |
| 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.
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