VISCOSUPPLEMENTATION THERAPY WITH INTRA-ARTICULAR HYALURONIC ACID: Fact or Fantasy?

Avaliar evidências que apoiem ou refutem o uso de viscossuplementação intra‐articular no tratamento de pacientes com osteoartrose sintomática de joelho. Foi feita uma revisão da literatura com o uso dos bancos de dados Medline, Pubmed e Cochrane Controlled Trial Register e Cochrane Databases Systematic Reviews (Cochrane Library). Foram considerados apenas estudos com elevado nível de evidências. O estudo incluiu a análise de ensaios clínicos randomizados que incluíram pelo menos 100 pacientes em cada grupo de intervenção, metanálises e revisões sistemáticas. Duas metanálises, cinco revisões sistemáticas e seis ensaios clínicos randomizados preencheram os critérios de inclusão desta revisão. Frente às melhores evidências existentes até o momento, não existe consenso para indicação e até mesmo contraindicação do uso da viscossuplementação intra‐articular em pacientes com osteoartrose sintomática do joelho (nível de evidência I e grau de recomendação A). Futuros estudos com metodologia adequada são necessários para elucidação dessa questão.

The aim here was to evaluate the evidence that might support or refute the use of intra‐articular viscosupplementation in treating patients with symptomatic knee osteoarthrosis. A review of the literature was conducted using the Medline, PubMed and Cochrane Controlled Trial Register databases and Cochrane database systematic reviews (Cochrane Library). Only studies presenting a high level of evidence were taken into consideration. This study included analysis on randomized clinical trials that included at least 100 patients in each intervention group, meta‐analyses and systematic reviews. Two meta‐analyses, five systematic reviews and six randomized clinical trials fulfilled the inclusion criteria for this review. In the light of the best evidence available so far, there is no consensus for indicating or even for contraindicating the use of intra‐articular viscosupplementation among patients with symptomatic knee osteoarthrosis (level of evidence I and degree of recommendation A). Further studies with appropriate methodology are needed to elucidate this matter.

The aim of this study was to determine the efficacy of Hylan G-F 20 on experimentally induced osteoarthritic changes in rabbit temporomandibular joint (TMJ). A 3 mg/ml concentration of sodium mono iodoacetate (MIA) had been injected into both joints of 24 rabbits to create osteoartrosis. The study group was injected with Hylan G-F 20 in one joint and saline in the contralateral joint as a control (once a week for 3 weeks). Histological changes in articular cartilage, osteochondral junction, chondrocyte appearance and subchondral bone were determined at 4, 6, and 8 weeks. Regarding cartilage, there was a statistically significant difference between the two groups at 4 weeks. Degenerative bony changes to subchondral bone were significantly higher in the controls. No statistical difference was found in the study group at 6 weeks. A positive correlation was found between osteochondral junction and subchondral bone in the study group at 8 weeks. The changes in chondrocyte appearance were significantly decreased in the study group at all follow-up times. Intra-articular injection of Hylan G-F 20 decreased cartilage changes in early stage TMJ osteoartrosis and clustering of chondrocytes showed the chondroprotective effects of Hylan G-F 20 caused by hypertrophic responses.

The use of intra-articular injections of high molecular weight elastoviscous solutions of hyaluronan or hylans (cross-linked derivatives of hyaluronan) to treat arthritis is termed viscosupplementation. The function of viscosupplementation is to restore the rheologic properties of synovial fluid. Although anecdotal data exist, no long-term studies regarding the use of viscosupplementation in the ankle have been published to date. The goal of this clinical trial was to compare pain reduction following ankle arthroscopy versus that following ankle arthroscopy combined with weekly intra-articular instillation of hylan G-F 20 during the first 3 postoperative weeks. In the series of patients described in this report, we found that both treatment groups experienced statistically significantly decreased pain following the intervention (P = .002 and P = .0009 for the arthroscopy alone and arthroscopy plus hylan groups, respectively), and that those who received 3 intra-articular injections of hylan G-F 20 following ankle arthroscopy improved statistically significantly (P = .0014) more than did those who underwent arthroscopy as a sole therapy. These preliminary results suggest that viscosupplementation combined with arthroscopy may be more beneficial than arthroscopy alone, and provide further insight into the role of viscosupplementation in the treatment of ankle osteoarthritis. Level of Clinical Evidence: 4

In this independent prospective randomized trial, we compared the clinical effectiveness, functional outcome and patient satisfaction following intra articular injection with two viscosupplementation agents — Hylan G-F-20 (n = 199) and Sodium Hyaluronate (n = 193) in patients with osteoarthritis (OA) of the knee. All patients were prospectively reviewed by blinded independent assessors at pre injection, 6 weeks, 3, 6, 12 months. Knee pain and patient satisfaction were measured on a visual analogue scale. Functional outcome was assessed using WOMAC, Oxford knee score and EuroQol EQ-5D scores. Knee pain on VAS improved from 6.7 to 3.2 by 6 weeks (p = 0.02) and was sustained until 12 months (3.7, p = 0.04) with Hylan G-F 20. In the Sodium Hyaluronate group, pain improved from 6.6 to 5.7 at 6 weeks (p > 0.05) and to 4.1 at 3 months (p = 0.04) but was sustained only until 6 months (5.9, p > 0.05). Improvement in the WOMAC pain subscale was significantly superior in the Hylan G-F 20 group at 3 months (p = 0.02), 6 months (p = 0.01) and 12 months (p = 0.007). There was no significant difference in the EQ-5D scores at 6 weeks and 3 months between the two groups. The numbers of treatment related adverse events were higher (39 vs. 30) in the Hylan G-F 20 group. One patient in the Hylan G-F 20 group who had a serious adverse event was also included in the final analysis. Although both treatments offered significant pain reduction, it was achieved earlier and sustained for a longer period with Hylan G-F 20. From this study, it appeared that the clinical effectiveness and general patient satisfaction are better amongst patients who received Hylan G-F 20.