EVALUATION OF THE EFFECT OF ADDING CORTICOSTEROID TO VISCOSUPPLEMENTATION: A PROSPECTIVE AND RANDOMIZED STUDY

Abstract

Purpose: The aim of this study is to assess if we can improve the initial results of viscosupplementation by the addition of corticosteroids to the procedure, watching for any interference on the long-term results. Methods: We evaluated 104 patients with knee osteoarthritis (OA), treated at the group for the treatment of osteometabolic diseases of IOT-FMUSP, São Paulo. All patients were receiving usual care for OA, and those who underwent to any kind of intraarticular injection or knee surgery in the last 6 months, or presented post-traumatic or rheumatoid arthritis were not included into the protocol. We applied the visual analogic scale of pain (VAS) and the algofunctional questionnaires WOMAC and Lequesne. Patients were randomized into two groups of 52 patients each. Group 1 received a single intraarticular injection of the knee with 6ml of Synvisc One (Hylan GF-20) alone. Patients in group 2 received an intraarticular injection of the knee with 6ml of Synvisc One (Hylan GF-20) and 1ml (20mg) of Hexacetonide Triamcinolone. The questionnaires were applied prior to the injection (week zero) and at weeks 1, 4, 12 and 24 after the procedure. This study was aproved by the University of São Paulo Clinics Hospital's ethics committee and entirely funded by FAPESP (Cientific research support foundation) - Grant number 2010/11450-9. It can be accessed at clinicaltrials.com. Results: The patient's characteristics of the two groups were compared with chi-square and Fisher's exact tests and were considered homogeneus. Most patiens were female (76%). The mean age was 62,7 years old. The average BMI of patients was 29.52. Most patients (34,6%) had a level 3 Kellgreen and Lawrence radiological classification for knee OA. The pre-injection scores were: Group 1- WOMAC = 50,21 (SD = 16,15); VAS = 67,27 (SD = 20,08); Lequesne = 13.24 (SD = 3,85). Group 2- WOMAC = 54,54 (SD = 17,58); VAS = 70,21 (SD = 23,59); Lequesne = 13.86 (SD = 4,18). These results were statistically compared and there was no statistic difference between groups. At Week 1, Group 2 showed a marked reduction for WOMAC and VAS scores, with a statistically significant difference compared with week zero and also when compared with Group 1 week one results. At week 4, group 2 still had better results for WOMAC and VAS compared to group 1, but with a p>0,05. The WOMAC and VAS results for weeks 12 and 24 were similar within the 2 groups. The Lequesne results had no statistically significant difference between the 2 groups at any moment. However, each group had a statistically significant improvement at weeks 1, 4, 12 and 24 compared to the baseline. Results are shown in tables and graphics below: None of the individuals characteristics such as age, genre, BMI or Kellgreen and Lawrence classification had any effects on the results. Adverse effects were: 4,8% of the patients presented effusion and 19,2% of the patients related discomfort or pain. There was no statistic difference between the groups. Conclusion: We concluded that the addition of 1ml of triancinolone to viscosupplementation brings great improvement to its early results and does not affect the long-term results, so it should be performed.