Hylan Groups Research Articles

IMPROVEMENTS IN HIP OSTEOARTHRITIS WITH LAVAGE, TRIAMCINOLONE AND HYLAN G-F20.

ABSTRACTObjective: To verify whether the use of Hylan G-F20 improves saline lavage and triamcinolone injection results in the treatment of hip osteoarthritis (HOA).Methods: 82 patients with HOA categorized as grades II and III severity, according to Kellgren and Lawrence criteria, were randomized into the groups: lavage and triamcinolone (G0); lavage, triamcinolone, and 2 mL of hylan G-F20 (G1); lavage, triamcinolone, and 4mL of hylan G-F20 (G2); lavage, triamcinolone, and 6mL of hylan G-F20 (G3). The VAS, range of motion (ROM), WOMAC, and Lequesne questionnaires were administered at baseline, one, three, six, and twelve months post-injection.Results: All groups showed clinically relevant improvements (> 20%) between baseline and first month post-injection, maintaining subjective results throughout the study period (p < 0.001). We found no differences between groups in any subjective evaluations (p > 0.05, for all). G2 and G3 obtained improved flexion results up to a year (p = 0.028). Hylan groups presented an improved external rotation since the first postoperative month and maintained the results up to a year (G1, p = 0.041; G2, p = 0.007), whereas G0 showed no improvement (p = 0.336).Conclusion: Hip lavage and triamcinolone injection, with or without the use of hylan, improves pain, function, and quality of life up to a year in HOA. Hylan may improve ROM up to one year. Level of Evidence IB, Randomized clinical trial.

Osteoarthritis of the knee refractory to standard care: comparison of intraarticular hylan G-F 20 with triamcinolone acetonide. A real life study in a developing country

Background: The purpose of this study was to assess the efficacy and safety of intraarticular Hylan G-F 20 and triamcinolone acetonide 80 mg (TA) in primary knee osteoarthritis (OA) refractory to standard care in a developing country. Methods: After injection of either Hylan or TA, patients were seen at 12 and 26 wk. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, pain, stiffness (100 mm visual analogue score), and European Quality of Life (EQ) score were measured as well as radiographic joint space change and joint severity grade. Results: The 26-week study was completed by 24 patients receiving Hylan (45 knees) and 21 receiving TA (38 knees). The primary outcome (improvement ≥40% of total WOMAC scores) at 12 wk in the Hylan group was 30 (66.7%) and in the TA group 5 (13.2%) (P&lt;0.00) and at 26 wk, 35 (77.8%) and 10 (26.3%), respectively, (P&lt;0.001). All secondary end points (pain, stiffness quality of life) improved significantly after 12 and 26 wk in both groups) but more in the Hylan group. The Kellgren-Lawrence radiographic grade improved more in the Hylan group than the TA group. The joint space improved at 12 wk in the Hylan and TA groups (0.4±0.8 and 0.1±0.5, respectively, P=0.044), and at 26 wk (0.6±1.1 and 0.0±0.5, respectively, P=0.003). No remarkable side effects were observed. Conclusions: In primary knee OA refractory to standard care, pain improved significantly more with Hylan G-F 20 than with TA after 12 and 26 wk as regards function and quality of life. Further studies are needed to assess longer time effects.

How efficacious are intra-articular viscosupplements in the management of early osteoarthritis knee?- A detailed comparative study with various outcome measures

Introduction: Osteoarthritis (OA) knee is the most common debilitating degenerative disorder beyond age 60 seeking medical attention for disabling pain and progressive reduction of joint movements and functional limitation. Conservative and rehabilitative measures remain the mainstay for early stages. In the recent years, intra articular injections particularly steroids and viscosupplementation are increasingly used for early stage management and have raised concerns about their efficacy. Various studies have claimed that intra-articular viscosupplementation with Hyaluronic acid (HA), specially hylan G-F 20 appeared to be safe, effective in pain relief and improved functional outcomes. Having this hypothesis, we wanted to analyze in detail by using various outcome scores (VAS, WOMAC, SF-36) and compare it with the steroids (methyl prednisolone acetate). Materials and methods: After the institutional review board clearance, this study was conducted as a randomized, prospective study between July 2012 and April 2015. Patients of both sexes beyond age 40 with symptomatic knee OA demonstrating radiological evidence of arthritis [Kellgren-Lawrence (K-L) grade of less than III were randomized into two groups. Patients in the steroid group (group 1, MPG) were subjected to two sittings of intra-articular 6-Methylprednisolone acetate 40mg each (day 0 and day 7). Patients in viscosupplementation group (group 2, HG) were given a single intra-articular injection of hylan G-F 20. Both groups were given standard physiotherapy regimen post-injection. We used the following parameters to measure outcome, 1) 100 mm visual analog pain scale (VAS), 2) Western Ontario and McMaster Universities Osteoarthritis index (WOMAC), 3) SF-36 health survey and 4) Range of motion (ROM) to document the baseline characteristics and subsequent follow ups at 2nd, 4th, 12th, 24th and 52nd week. Results: Among the 68 enrolled patients, no statistically significant differences were found regarding demographic patterns and the baseline outcome scores of patients between two groups. The mean age, grade and duration at presentation among the two groups were 56.57 /59.83 years, grade 2 and 3.4 / 3.8 years respectively. At 54 weeks, HG group had a mean ROM of 126.93o compared to 120.83oin the MPG group (p=0.001). Regarding VAS, better pain relief (24.80) was noted in the MPG during early period (3 months) with the VAS scores doing significantly better in the HG group (18.67) as against MPG (61.18). In the HG group, WOMAC scores revealed a delayed (>4 weeks) onset of improvement, with plateau formation at 6th month (28.43). Early improved WOMAC scores in the MPG showed a decreasing trend reaching pre-injection baseline level (55.93) within 3 months. Post-treatment SF-36 health survey at final follow-up revealed that, patients in hylan group showed greater improvement of mean score from baseline in all 8 functional categories compared to corticosteroid group (p value < 0.001). Conclusion: With regard to the intra articular injections in the management of early osteoarthritis, Hylan-G-F-20 has shown a sequential improvement in quality of life beyond 3 weeks post-injection lasting for more than six months. Methylprednisolone acetate gave improved early (

SAT0333 Efficacy of sodium hyaluronate versus hylan G-F 20 in the treatment of tibiofemoral osteoarthritis

BackgroundCrosslinked hylan is perceived to have longer efficacy than native hyaluronic acid in the treatment of osteoarthritis (OA).ObjectivesTo compare the efficacy of intra-articular injections of native sodium hyaluronate 1% (SH)...

The Role of Viscosupplementation in the Ankle Using Hylan G-F 20

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. 4.

Hylan Versus Corticosteroid Versus Placebo for Treatment of Basal Joint Arthritis: A Prospective, Randomized, Double-Blinded Clinical Trial

Conservative, nonsurgical therapies for basal joint osteoarthritis, such as thumb spica splinting and intra-articular corticosteroid injections, remain the mainstays for symptomatic treatment. This study compares intra-articular hylan, corticosteroid, and placebo injections with regard to pain relief, strength, symptom improvement, and metrics of manual function in a randomized, controlled, double-blinded study. Sixty patients with basal joint arthritis were randomized to receive 2 intra-articular hylan injections 1 week apart, 1 placebo injection followed by 1 corticosteroid injection 1 week later, or 2 placebo injections 1 week apart. Patients were evaluated at 2, 4, 12, and 26 weeks and assessed with Visual Analog Scale pain scores, strength measures, difference scores, Disabilities of the Arm, Shoulder, and Hand (DASH) scores, and range of motion measurements. All groups reported pain relief at 2 weeks. The steroid and placebo groups had significantly less pain at week 4 compared with baseline, but this effect disappeared by week 12. Only hylan injections continued to provide pain relief at 12 and 26 weeks compared with baseline. There were no significant differences in pain between groups at any time. At 12 and 26 weeks, the hylan group had improved grip strength compared with baseline, whereas the steroid and placebo groups were weaker. At 4 weeks, the steroid group reported in the difference score a greater improvement in symptoms (68%) compared with the hylan (44%) and placebo (50%) groups. Whereas at 26 weeks the hylan group reported the largest improvement in symptoms (68%), this was not statistically different from the placebo (47%) and steroid (58%) groups. There were no significant differences in Disabilities of the Arm, Shoulder, and Hand scores or range of motion among the groups. There were no complications from any injection. There were no statistically significant differences among hylan, steroid, and placebo injections for most of the outcome measures at any of the follow-up time points. However, based on the durable relief of pain, improved grip strength, and the long-term improvement in symptoms compared with preinjection values, hylan injections should be considered in the management of basal joint arthritis of the thumb. Therapeutic I.

Efficacy and safety of intraarticular hylan or hyaluronic acids for osteoarthritis of the knee: A randomized controlled trial

To compare the efficacy and safety of intraarticular hylan and 2 hyaluronic acids (HAs) in osteoarthritis (OA) of the knee. This was a multicenter, patient-blind, randomized controlled trial in 660 patients with symptomatic knee OA. Patients were randomly assigned to receive 1 cycle of 3 intraarticular injections per knee of 1 of 3 preparations: a high molecular weight cross-linked hylan, a non-cross-linked medium molecular weight HA of avian origin, or a non-cross-linked low molecular weight HA of bacterial origin. The primary outcome measure was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score at 6 months. Secondary outcome measures included local adverse events (effusions or flares) in injected knees. During months 7-12, patients were offered a second cycle of viscosupplementation. Pain relief was similar in all 3 groups. The difference in changes between baseline and 6 months between hylan and the combined HAs was 0.1 on the WOMAC pain score (95% confidence interval [95% CI] -0.2, 0.3). No relevant differences were observed in any of the secondary efficacy outcomes, and stratified analyses provided no evidence for differences in effects across different patient groups. There was a trend toward more local adverse events in the hylan group than in the HA groups during the first cycle (difference 2.2% [95% CI -2.4, 6.7]), and this trend became more pronounced during the second cycle (difference 6.4% [95% CI 0.6, 12.2]). We found no evidence for a difference in efficacy between hylan and HAs. In view of its higher costs and potential for more local adverse events, we see no rationale for the continued use of hylan in patients with knee OA.

Comparison of the therapeutic efficacy of TENS versus intra-articular hyaluronic acid injection in patients with knee osteoarthritis: A prospective randomized study

Knee osteoarthritis (OA) is perceived as a major public health problem, and today, various treatment modalities are used to manage this condition. The purpose of this study was to assess and compare the efficacy of transcutaneous electrical nerve stimulation (TENS) and intra-articular hylan G-F 20 (Synvisc; Genzyme Corporation, Ridgefield, NJ) in patients with symptomatic knee OA. A total of 60 patients with primary knee OA were randomized into 2 treatment groups. TENS was applied for 3 weeks in the first group, and in the second group, hylan G-F 20 was injected intra-articularly once a week for 3 weeks. Patients were then followed for 6 months. Disease severity was measured with the Lequesne Index. Efficacy in terms of pain, functional status, and quality of life was assessed through analysis of changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and short Form 36 Health Survey (SF-36) scores. Adverse events were monitored throughout the study. WOMAC pain scores were improved at the first control visit in the TENS group and in the viscosupplementation group; this improvement was statistically significant. WOMAC stiffness scores showed a statistically significant decrease in the TENS group at the first control visit. Stiffness did not decrease during the first month in the second group; however, these patients exhibited improvement during the sixth month after injection. Physical function scores and SF-36 total scores did not change in either group after treatment. Pain relief was observed at the first month and continued throughout the 6-month follow-up period in both groups. Stiffness decreased by the sixth month in both groups. Improvement in WOMAC physical function scores was greater in the intra-articular hylan group than in the TENS group at the end of follow-up; however, quality of life was not improved in either group. These therapies used in combination may alleviate symptoms in patients with OA.

A comparison of two different intra-articular hyaluronan drugs and physical therapy in the management of knee osteoarthritis

The aim of this study was to compare the effects of physical therapy agents (PTA) and two different intra-articular hyaluronan drugs (sodium hyaluronate (NaHA) and hylan G-F 20) on knee osteoarthritis (OA). The randomised, single-blind study, with 12 months of follow-up, was performed on 80 patients diagnosed as knee OA. The patients were randomly divided into two treatment groups: patients in group 1 were given weekly intra-articular hyaluronan treatment which consisted of either hylan G-F 20 or NaHA during the first 3 weeks and in the sixth month; PTA was applied to each patient in group 2 five times a week for 3 weeks with a series of infrared, short-wave diathermy-pulsed patterns and interferential therapy. Clinical assessments for each patient were made at 1, 3, 6, 9 and 12 months using the following measures: spontaneous pain, pain at rest, pain at night, pain on touch, pain on movement, 15 m walking time, range of motion, short form 36 (SF-36), Western Ontario and McMaster University Osteoarthritis Index (WOMAC) global assessment. There was significant improvement in all variables measured in both groups during the follow-up except the WOMAC-stiffness and range of the motion. The improvement of pain (at night, at rest, SF-36) and SF-36 social functioning subscales was greater in the PTA group. Consequently, in the subgroup analyses, there was no difference between PTA and hylan groups for this improvement. In the comparison of two drugs, the reduction of pain on touch and WOMAC-function was greater in hylan group than that of NaHA. No serious local or systemic effects were observed following injections. Although all patients had improvement, PTA was superior to hyaluronan group for no activity-related pain and functional performance. On the other hand, this study supports the preferential use of hylan over NaHA in patients with knee OA.

Effect of hylan G-F 20 in achilles’ tendonitis: An experimental study in rats

Tatari H, Skiak E, Destan H, UlukuşÇ, Özer E, Satoğlu S. Effect of hylan G-F 20 in Achilles’ tendonitis: an experimental study in rats. Arch Phys Med Rehabil 2004;85:1470–4. Objective To investigate the local effects of hylan G-F 20 on locally administered corticosteroid-induced experimental Achilles’ tendonitis. Design Before-after trial. Setting Institutional practice. Animals Convenience sample of 18 male Wistar white rats (weight range, 322–375g). Interventions After performing Achilles’ degeneration with local corticosteroid injections, the rats were divided into 4 groups. The right Achilles’ tendon of the rats served as the hylan injection group and the left tendon as the control group, which was injected with saline at 5-day intervals. The tendons and paratenons were excised at the end of 60 or 75 days and evaluated histopathologically and statistically. Main outcome measure Histopathologic changes, including staining affinity, nuclear appearance, fibrillar appearance for tendon and thickness, occurrence of fibrosis and edema, capillary changes, and inflammation for paratenon, were assessed according to a semiquantitative scoring system. The Mann-Whitney U test was used for statistical analysis, with a P value of .05 or less considered statistically significant. Results Semiquantitative scoring of histopathologic changes showed that histologic appearances differed between the hylan and saline groups and between 2 hylan groups. Hylan-injected tendons and paratenons demonstrated significantly lower scores, especially after 75 days. Conclusions Hylan G-F 20 has a promising curative effect on the tendon and paratenon and can be used in Achilles’ tendonitis. This finding should be supported by biomechanical and biochemical studies.