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Large study tests efficacy of three, smaller daily doses of viscosupplementation
Adverse events occurred in 9.8 % of the single-dose group vs. 11.2% of the three-dose group.
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A study of more than 4,000 patients with osteoarthritis of the knee indicates that viscosupplementation administered in either a large-dose single injection or three, smaller dose injections significantly reduces pain and improves function at 6 months.
In their prospective longitudinal cohort study, presented at the American Academy of Orthopaedic Surgeons 2012 Annual Meeting, Raman and colleagues found that 11.2% of patients who received three 2 mL daily injections of Hylan G-F 20 (Synvisc-One; Genzyme) reported injection or treatment-related adverse events compared to 9.8% of those who had a single 6 mL injection.
“As an index procedure for [osteoarthritis] OA, viscosupplementation appears to be a good agent for reducing pain for a period of up to about 12 months time,” lead author Raghu Raman, FRCS, said. “Certainly, adverse events are low. There is a choice of dosing with Hylan G-F 20 to fit the need of the patient, either a single dose or three times 2 mL, and both appear to be working well.”
He added, “It appears that one dose may be safer in the long run, although we have to evaluate it with larger numbers.”
The study included 4,400 patients with knee pain of at least 60 mm on a 100 mm Visual Analog Scale (VAS) who were treated at a single institution during a 6-year period. The mean patient age was 60 years and most had grade III OA. The researchers who were blinded to treatment followed patients for up to 26 weeks using outcome measures such as the VAS, WOMAC, SF-12, Oxford knee score and Euroqol 5-D. Analgesics were prohibited for 24 hours before follow-up and patients could not take NSAIDs during the study.
The researchers found no significant differences between groups regarding patient demographics and found that both groups showed significant reductions in pain. WOMAC pain and function subscales improved 65% from baseline at 26 weeks. VAS scores improved from 69 points to 37 points at 6 months. In addition, the investigators discovered no significant differences between the groups for any outcome measure at 26 weeks. The researchers noted a “quicker onset of pain relief at 6 weeks” for the single-dose group, while the three-dose group showed pain relief at 8 weeks to 12 weeks.
Serious adverse events occurred in six patients in the three-dose group “requiring aspiration or admission” compared to three patients in the single-dose group, Raman said. – by Renee Blisard
Reference:
- Raman R, Rambani R, Johnson GV, et al. Safety, efficacy and outcome of 4,400 patients treated with viscosupplementation for osteoarthritis of knee. Paper #264. Presented at the American Academy of Orthopaedic Surgeons 2012 Annual Meeting. Feb 7-11. San Francisco.
For more information:
- Raghu Raman, FRCS, can be reached at Spire Hull and East Riding Hospital, Lowfield Road Anlaby, Hull, East Riding of Yorkshire HU10 7AZ, United Kingdom, 01482; +44 01482 659471; email: raghu1177@yahoo.com.
- Disclosure: Raman is on the speaker’s bureau and does paid presentations for Genzyme and JRI.