Injection Of Hylan Research Articles

Three Weekly Intra-Articular Injections of Hylan G-F 20 vs Arthrocentesis in Patients with Chronic Idiopathic Knee Osteoarthritis: A Multicenter, Evaluator- and Patient-Blinded, Randomized Controlled Trial

Knee osteoarthritis is a leading cause of disability worldwide. Symptoms can vary over time, leading to episodes of worsened symptoms known as flares. Intra-articular injection of hyaluronic acid has demonstrated long-term symptomatic relief in the broader knee osteoarthritis population, although its use in the flare population has not been extensively examined. To assess the efficacy and safety of 3 once-weekly intra-articular injections of hylan G-F 20 (as single and repeat courses) in patients with chronic knee osteoarthritis, including a subpopulation that experienced flare. Prospective randomized controlled, evaluator- and patient-blinded, multicenter trial with 2 phases: hylan G-F 20 vs arthrocentesis only (control) and 2 courses vs single-course hylan G-F 20. Primary outcomes were visual analog scale (0-100 mm) pain scores. Secondary outcomes included safety and synovial fluid analysis. Ninety-four patients (104 knees) were enrolled in Phase I, with 31 knees representing flare patients. Seventy-six patients (82 knees) were enrolled in Phase II. Long-term follow-up was 26 to 34 weeks. In flare patients, hylan G-F 20 showed significantly more improvement than the controls for all primary outcomes except pain at night (P = 0.063). Both 1 and 2 courses of hylan G-F 20 showed significant improvements from baseline for primary outcomes with no differences in efficacy between groups in the intention-to-treat population at the end of Phase II. Two courses of hylan G-F 20 showed better improvement in pain with motion (P = 0.0471) at long-term follow-up. No general side effects were reported, and local reactions (pain/swelling of the injected joint) resolved within 1 to 2 weeks. Hylan G-F 20 was also associated with reduced effusion volume and protein concentration. Hylan G-F 20 significantly improves pain scores vs arthrocentesis in flare patients with no safety concerns. A repeat course of hylan G-F 20 was found to be well tolerated and efficacious.

HYLAN G-F 20 VERSUS TRIAMCINOLONE IN THE TREATMENT OF PRIMARY SHOULDER OSTEOARTHRITIS. RANDOMIZED TRIAL.

ABSTRACTIntroduction The aim of this study was to evaluate the effect of using an intra-articular injection of hylan G-F 20 (HA group) on primary shoulder osteoarthritis compared with an intra-articular triamcinolone injection (T group).Materials and Methods The patients were randomized into 2 groups: in the HA group a single dose of intra-articular hylan G-F 20 was administered and in the T control group a dose of triamcinolone 20 mg was administered. The participants were evaluated at 1 week, 1, 3, and 6 months after the procedure. The patients were evaluated for pain, range of motion, Constant score, modified UCLA score, and SPADI.Results Seventy patients met the inclusion criteria and were randomized to the HA (38) and T (32) groups. Improvements in range of motion were significant (p > 0.05). We observed decreases in the general visual analog scale (VAS) for pain in both groups, especially in the cases of mild and moderate arthritis that received hyaluronic acid (mean values from 8.1 initially to 4.9 after 6 months) (p = 0).Conclusions Both injections led to a decrease in pain and an increase in patient satisfaction. The results tend to be better and longer lasting in patients receiving hyaluronic acid. Level of evidence II b; Cohort study.

Viscosupplementation may preserve tibial cartilage and collagen in osteoarthritis: findings from a preclinical model of osteoarthritis

PurposeIntraarticular (IA) hyaluronic acid (HA) injection is used to reduce pain and improve mobility in knee osteoarthritis (OA). Little is known about histopathological changes underlying HA efficacy. This study investigated dose-related effects of 1% sodium hyaluronate (BioHA) on knee joint histopathology and pain responses in a medial meniscal tear (MMT) rat model of OA.MethodsFollowing MMT surgery, rats were randomized into treatment groups: single IA injection of vehicle, BioHA, or an avian-derived hyaluronic acid (hylan G-F 20) on Day 7; or 3 weekly injections of vehicle or BioHA on Days 7, 14, and 21. On Day 35, joints were evaluated by microscopic histopathology for cartilage degeneration, collagen degeneration, synovitis, and cytokine expression (tumor necrosis factor α, transforming growth factor β).ResultsJoint pathology for control animals was consistent with that expected for the MMT model. Rats treated with 3 injections of IA-BioHA had significantly reduced collagen degeneration (21%) relative to control animals. No significant change in collagen degeneration was observed for rats given a single injection of hylan G-F 20 or IA-BioHA compared to control animals. HA treatment did not affect cytokine expression.ConclusionsIA-BioHA viscosupplementation in a rat MMT model of OA showed preservation of joint cartilage and collagen. This effect was most pronounced on tibial surfaces having less severe injury, suggesting that treatment should be initiated early in the disease process. A comparison of responses to IA-BioHA or hylan G-F 20 in the MMT rat OA model suggest IA-BioHA may be more effective in preserving joint connective tissue.

Factors Associated with Knee Arthroplasty in a Knee Osteoarthritis Patient Cohort Treated with Intra-articular Injections of Hylan G-F 20.

Hylan G-F 20 viscosupplementation can be used to treat knee osteoarthritis pain. This study evaluated time to knee arthroplasty (KA), KA risk factors, and health care resource utilization in patients aged ≥18 years with claims in the Optum Clinformatics Data Mart database (2006-2016) for knee osteoarthritis treated with at least one course of hylan G-F 20. Kaplan-Meier analysis estimated KA risk from osteoarthritis diagnosis and first hylan G-F 20 treatment. KA risk factors were determined using multivariate Cox regression. Among 62,033 patients treated with hylan G-F 20 and/or hylan G-F 20 single intra-articular injection, 60 to 64% did not undergo KA 8 years following first injection. KA risk factors from time of osteoarthritis diagnosis and first hylan G-F 20 treatment were similar: increased age, fewer comorbidities, fewer hylan G-F 20 treatments, female sex, and no ultrasound/fluoroscopy for injection guidance. Patients who underwent KA versus those who did not had more office visits and claims for opioids, nonsteroidal anti-inflammatory drugs, and physical therapy. Patients less likely to undergo KA were younger (<40 years), had more comorbidities, received more courses of hylan G-F 20, were males, or received ultrasound/fluoroscopic injection guidance. Patients who did not receive KA versus those who did used fewer health care resources.

Efficacy of intra-articular hyaluronic acid in relief of pain in Kellgren and Lawrence grade 2 and 3 osteoarthritis knee

Introduction: Intra-Articular Hyaluronic Acid (IA-HA) supplementation not only improvises the synovial fluid flow dynamics and viscoelasticity but also potentially offers a positive effect on the arthritic disease process by promoting in vivo IAHA production and by providing an intra-articular anti-inflammatory effect. Objective: The primary objective of this study was to compare a single 6ml, intra-articular injection of hylan GF-20 with conservative treatment in patients with symptomatic mild to moderate knee Osteoarthritis (OA). Methodology: Patients with primary OA knee pain were randomly assigned to arthrocentesis plus a 6ml intra -articular injection of either hylan G-F 20 or conservative methods of treatment in a prospective, single-blinded (evaluator) randomised control study. Results were evaluated at Pre Injection, 3, 8, 16 and 24 weeks post-injection. The primary outcome criterion was change from baseline over 24 weeks in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index and VAS Score. Results: A total of 70 patients (Kellgren–Lawrence grade II or III) was randomly assigned. Patients receiving hylan G-F 20 experienced statistically significantly greater improvements in WOMAC scores and VAS scores, than patients receiving conservative treatment. No increased risk of local adverse events was observed. Conclusions: This prospective randomised control study demonstrated that, in patients with knee osteoarthritis, a single 6 ml intra-articular injection of hylan G-F 20 is safe and effective in providing statistically significant, clinically relevant pain relief over 24 weeks, with a modest difference versus conservative treatment.

Evaluating the use of intra-articular injections as a treatment for painful hip osteoarthritis: a randomized, double-blind, multicenter, parallel-group study comparing a single 6-mL injection of hylan G-F 20 with saline

Hip osteoarthritis (OA) is difficult to treat. Steroid injections reduce pain with short duration. With widespread adoption of office-based, image-guided injections, hyaluronic acid is a potentially relevant therapy. In the largest clinical trial to-date, we compared safety/efficacy of a single, 6-mL image-guided injection of hylan G-F 20 to saline in painful hip OA. 357 patients were enrolled in a multicenter, double-blind, randomized saline placebo- controlled trial. Subjects were ≥35 years of age, with painful (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]-A1:5.0-8.0; numeric rating scale [NRS]: 0-10) mild-to-moderate hip OA (Kellgren-Lawrence grade II/III) and minimal contralateral hip pain (WOMAC-A1<4). Outcome measures included "pain on walking" (WOMAC-A1 and -A), Patient Global Self-Assessment (PTGA), WOMAC-A1 responder rate (+≥2 points on NRS), and adverse events (AEs) over 26 weeks. 357 patients (hylan G-F 20 single:182; saline:175) were enrolled. Both groups demonstrated significant pain improvement from baseline over 26 weeks (P<0.0001); saline-induced pain reduction was a remarkable 35%. WOMAC-A and PTGA scores also significantly improved (P<0.0001). No statistically significant difference was observed between groups in WOMAC-A1 scores (hylan G-F 20 single:-2.19±0.16; saline:-2.26±0.17) or WOMAC-A1 responders (41-52%). Treatment-related AE rates at target hip were similar (hylan G-F 20 single:23 patients [12.8%]; saline:12 [7.0%]). Posthoc analysis found, despite protocol requirements, many patients had psychological (31%) or potential neuropathic pain (27.5%) conditions. A single 6-mL hylan G-F 20 injection or saline for painful hip OA resulted in similar, statistically significant/clinically relevant pain and function improvements up to 6 months following injection; no differences between hylan G-F 20 and saline placebo were observed.

Assessing the Impact of a Novel Smartphone Application Compared With Standard Follow-Up on Mobility of Patients With Knee Osteoarthritis Following Treatment With Hylan G-F 20: A Randomized Controlled Trial.

BackgroundOsteoarthritis (OA) is a leading cause of disability in the United States. Although no disease-modifying therapies exist, patients with knee OA who increase walking may reduce risk of functional limitations.ObjectiveThe objective of the study is to evaluate the impact of a mobile app (OA GO) plus wearable activity monitor/pedometer (Jawbone UP 24) used for 90 days on the mobility of patients with knee OA treated with hylan G-F 20.MethodsPatients with knee OA aged 30 to 80 years who were eligible to receive hylan G-F 20 and were familiar with smartphone technology were enrolled in this randomized, multicenter, open-label study. Patients who had a body mass index above 35 kg/m2 were excluded. All patients received a single 6-mL injection of hylan G-F 20 and wore the Jawbone monitor. The patients were then randomized 1:1 to Jawbone and OA GO (Group A; n=107) with visible feedback (unblinded) or Jawbone only (Group B; n=104) with no visible feedback (blinded). The primary endpoint was mean change from baseline in steps per day at day 90 between Groups A and B.ResultsBaseline characteristics were similar between groups. There were significant differences between the increases in least squares (LS) mean number of steps per day (1199 vs 467, P=.03) and the mean percentage change (35.8% vs 11.5%, P=.02) from baseline in favor of Group A over Group B. There was a greater reduction in pain from baseline during the 6-minute walk test in Group A versus Group B. (LS mean change: −55.3 vs −33.8, P=.007). Most patients (65.4%) and surveys of physicians (67.3%) reported they would be likely or very likely to use/recommend the devices. Patient Activity Measure-13 scores improved from baseline (LS mean change for Groups A and B: 5.0 vs 6.9), with no significant differences between groups. The occurrence of adverse events was similar in the 2 groups.ConclusionsUse of a novel smartphone app in conjunction with a wearable activity monitor provided additional improvement on mobility parameters such as steps per day and pain with walking in the 6-minute walk test in patients with knee OA who were treated with hylan G-F 20. Results also highlight the amenability of patients and physicians to using mobile health technology in the treatment of OA and suggest further study is warranted.

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 (

Pain relief and improved physical function in knee osteoarthritis patients receiving ongoing hylan G-F 20, a high-molecular-weight hyaluronan, versus other treatment options: data from a large real-world longitudinal cohort in Canada

From the Southwestern Ontario database, one of the largest primary-care datasets in Canada, 1,263 patients with osteoarthritis (OA) of one or both knees were identified who received two consecutive series of intra-articular (IA) injections of hylan G-F 20 preparation and no other prescribed OA medications, and were evaluated fully between 2006 and 2012. A cohort of 3,318 demographically matched OA patients who had not been treated with IA injection therapy was identified from the same database for comparison. Responses to therapy were assessed by means of a 10-point visual analog scale (VAS) for pain at rest and after completion of a 6-minute walk test (6MWT), while physical capacity was measured by performance in the 6MWT itself. After two cycles of hylan G-F 20 therapy, the average VAS score for pain at rest declined from 7.82±1.27 at baseline to 4.16±1.51 (average change 3.66±1.78, significantly more than the reduction of 3.12±2.03 seen in the reference group [P<0.012]) and the average VAS score for pain after the 6MWT decreased by 5.56±1.74 points (from 9.58±0.4 at baseline to 4.02±1.67 at the final assessment), a significantly larger change than that seen in the reference group (Δ2.99±1.85; P<0.001 for intergroup comparison). Distance walked in the 6MWT increased on average by 115 m, significantly more than that seen in the reference group (Δ91 m; P<0.001 for intergroup comparison). These findings from a primary-care database suggest sustained benefits in terms of pain and physical function from repeat cycles of IA injections of hylan G-F 20 and no other prescribed OA medications in adults with OA of the knee.

Hand Osteoarthritis: An Update on Therapy

Objectives: This literature review aims to summarize and discuss the most novel clinical studies relevant to the treatment of hand osteoarthritis. Patients and methods: A comprehensive search using Medline and PubMed was performed. Results were restricted to the period between January 2008 and May 2014, and included randomized controlled trials and reviews. The bibliographies of articles retrieved through this search were searched manually for additional relevant references. Results: The latest methods of nerve mobilization, splinting, exercise, and other diverse nonpharmacological treatments have led to significant functional and symptomatic improvements. Topical nonsteroidal antiinflammatory drugs’ clinical beneficence was reinforced and corticosteroid injections were shown to be superior to hyaluronic acid injections. Other pharmacological therapies, such as Hylan injections and synergistic drugs, also showed promise. Antitumor necrosis factor was suggested to play role as a potential disease-modifying agent. Surgical procedures such as arthroscopic debridement, synovectomy of the trapeziometacarpal joint, and early tendon arthroplasty were promising with long-term benefits when used as early interventions. Conclusion: Recent studies show that emerging therapies may play role in the clinical setting as an upgrade over current practices, and that earlier surgical interventions should be considered in the management process.

Long-Term (1-Year) Safety and Efficacy of a Single 6-mL Injection of Hylan G-F 20 in Indian Patients with Symptomatic Knee Osteoarthritis

Introduction: The prevalence of symptomatic knee osteoarthritis (OA) among Asians ≥65 years is estimated to double by 2040. This study was designed to evaluate the safety and efficacy of a single, 6-mL intra-articular injection of hylan G-F 20 in Indian patients with knee OA at 26 weeks through to 52 weeks.Methods: This study was an open-label, multicentre, phase 4 clinical trial. Enrolled patients (N=394) were ≥30 years old with Kellgren-Lawrence grade 1–3 OA; all patients received hylan G-F 20. WOMAC, SF-12, PTGA, and COGA scores, and OA medication use were evaluated at weeks 1, 4, 12, 26, 39, and 52 (initial treatment phase). At 26, 39, or 52 weeks, eligible patients could participate in a repeat treatment phase. McNemar-Bowkers, paired t-tests and ANOVA analyses were performed (alpha=0.05).Results: At 26 weeks, statistically significant changes from baseline were observed in all efficacy parameters, including the primary efficacy endpoint of WOMAC A1 (p<0.0001). Improvements continued for 52 weeks. No significant changes occurred in concomitant medication use. Eleven patients (2.8%) were re-injected at week 26 or 52. After repeat injection, statistically significant decreases were observed in WOMAC A1, WOMAC C and PTGA scores (p≤0.028). Twenty-three (5.8%) patients reported 26 local target knee AEs.Conclusion: Among Indian patients within this study, a 6-mL hylan G-F 20 injection was well tolerated and effective in treating symptomatic knee OA with significant long-term (1 year) improvement of outcomes. When needed, repeat treatment was safe and efficacious for 4 weeks.Trial Registration: Clinical Trial Registry of India (CTRI/2010/091/000052) www.ctri.nic.in/Clinicaltrials/login.php.

Biocompatibility of cross-linked hyaluronate (Gel-200) for the treatment of knee osteoarthritis

To compare the biocompatibility and immunogenicity of two intra-articular hyaluronan formulations, Gel-200 (Gel-One(®)) and hylan G-F 20 (Synvisc(®) series). A comparison of the biocompatibility of Gel-200 and hylan G-F 20 was made using a rat subcutaneous air pouch model and the knee joint of normal rabbits. Immunogenicity was evaluated using a homologous passive cutaneous anaphylaxis (PCA) assay in guinea pigs. In the air pouch model in rats, characteristic fibrous belts formed in the subcutaneous tissue. Injection of hylan G-F 20 into the air pouch induced granulomatous nodules primarily composed of macrophages, multinucleated giant cells, and eosinophils accompanied with the test material in the center of the nodules in the fibrous belt. Furthermore, the thickness of the fibrous belt in the hylan G-F 20 group increased significantly compared to the saline group. Injection of Gel-200 into the air pouch induced neither granulomatous inflammation nor significant thickening of fibrous belt, while foamy macrophages containing the test material were observed. Intra-articular injection of hylan G-F 20 into the rabbit knee joints induced granulomatous inflammation, eosinophil infiltration, and significant increase in the number of cells in the synovial fluid, while these findings were absent in the Gel-200 group. In the immunogenicity assay, hylan G-F 20 induced a positive PCA reaction, but the Gel-200 did not. Gel-200 showed more favorable biocompatibility and less immunogenicity compared to hylan G-F 20. Gel-200 is expected to be a single injection hyaluronan product with less safety concerns for the treatment of knee osteoarthritis (OA) pain.

Immunological response to bolus versus multiple injections of hylan G‐F 20 (Synvisc®) in a murine biocompatibility model

Local tissue reactivity to intra-articular injections of hyaluronic acid hylan G-F 20 (Synvisc) has been described. We used a murine biocompatibility model to study the inflammatory response to Synvisc after a single bolus injection versus the traditional three shot series of injections. Air pouches were established subcutaneously in BALB/c mice, which were injected with phosphate-buffered saline (PBS), 5 mg ultra-high molecular weight polyethylene particles (to simulate synthetic joint wear debris, positive control), 0.5 mL Synvisc (one injection/week for three weeks, harvested 14 days after last injection), or 1.5 mL Synvisc bolus (harvested either 14 or 28 days after last injection). Inflammatory gene expression and inflammation of air pouch tissue, and serum antibody titers to Synvisc were determined. Inflammation was observed with all Synvisc treatments relative to PBS (p < 0.01). However, the three injection series of Synvisc resulted in significantly (p < 0.05) greater tumor necrosis factor-alpha gene expression compared to both PBS and bolus single shot Synvisc harvested after 14 or 28 days. While all Synvisc treatments resulted in serum antibodies to Synvisc (p < 0.02 compared to PBS control group), mice that received three injections of Synvisc had higher levels than mice receiving a single injection (p < 0.01). These results demonstrate that a single bolus injection of Synvisc led to less inflammation and a lower antibody response when compared to the three-shot series of injections, supporting the current change in treatment from multiple injections to a single injection of Synvisc .

Bilateral Hip Joint Hylan G-F 20 Granulomatous Synovitis due to Viscosupplementation Injections.

We present the diagnosis of bilateral granulomatous inflammation of the hip joints associated with Hylan G-F 20 viscosupplementation injections. Clinicians recommending therapeutic Hylan injections for the management of hip arthritis should maintain clinical awareness regarding this potential complication.

AB1468-HPR Long term (1-yr) efficacy and safety of single 6ml injection of hylan G-F 20 in indian patients with symptomatic knee OA

BackgroundSingle 6mL intraarticular injection of hylan GF 20 is safe and effective with significant reduction in walking pain up to 52 weeks compared to baseline in this prospective, open label,...

Acute inflammation with induction of anaphylatoxin C5a and terminal complement complex C5b-9 associated with multiple intra-articular injections of hylan G-F 20: a case report

The purpose of this case report was to investigate local immune mechanisms present during an acute inflammatory flare initiated by viscosupplementation with hylan G-F 20 in a patient with osteoarthritis (OA) and past meniscectomy. A patient with a history of bilateral OA and partial left knee meniscectomy, who had received three injections of hylan G-F 20, was diagnosed with an acute flare reaction in the left knee. Her chart was evaluated for clinical, radiological, and laboratory findings and for clinical follow-up. Histopathological synovial examination and real-time polymerase chain reaction (RT-PCR) for genes with major roles in local inflammation and enzyme-linked immunosorbent assays (ELISAs) for markers of complement activation and cytokines were performed. To study the impact of the inflammatory and immune features we compared the case patient with groups of three representative OA and three rheumatoid arthritis (RA) patients. The patient exhibited evidence of highly increased acute phase reactant C-reactive protein (CRP) in the blood. The pathological examination of the synovial membrane identified abundant fibrinous exudate with numerous particles of hyaluronan surrounded by a dense infiltrate of neutrophils and eosinophils. The synovium had moderate hypertrophy and sclerosis as well as an inflammatory infiltrate predominantly composed of T lymphocytes and macrophages with scattered perivascular eosinophils and neutrophils. Immunoperoxidase staining identified numerous deposits of C5b-9 in the fibrinous exudates and the synovial membrane of the patient. Similar findings were observed in the RA patients, whereas deposits were rare in OA synovial samples. In addition, both anaphylatoxin C5a and the terminal complement complex C5b-9 were present at high levels, comparable to those in RA patients. The levels of mRNA for interleukin-1 beta (IL-1β), IL-6, and the neutrophil marker myeloperoxidase (MPO) were markedly increased compared to those in the RA and OA patients. This present study is indicative of a pseudo-septic acute inflammatory reaction in response to local accumulation of hylan G-F 20 with the activation of complement and local invasion of pro-inflammatory cells.

Effectiveness of intra-articular hyaluronan (Synvisc, hylan G-F 20) for the treatment of first metatarsophalangeal joint osteoarthritis: a randomised placebo-controlled trial

ObjectivesTo evaluate the effectiveness of a single intra-articular injection of hylan G-F 20 (Synvisc) for symptomatic first metatarsophalangeal joint (MTPJ) osteoarthritis (OA).MethodsParticipants (n = 151) with symptomatic first MTPJ OA...

Predictors of successful treatment in patients receiving intra‐articular injections of hylan G‐F 20 or saline for painful first MTPJ OA

Methods One hundred and fifty one participants with first MTPJ OA received an intra-articular injection of 1ml hylan GF 20 or saline. Potential predictors included intervention group, demographics, height weight, BMI, symptom duration and severity, the Foot Health Status Questionnaire (FHSQ), first MTPJ dorsiflexion range of motion and radiographic OA severity (osteophytes and joint space narrowing as individual features in either the dorsal and lateral view, or as a combination, where scores of 2 for any feature in any view was considered ‘definite’ OA). The primary measure was a 15-point change in symptoms scale (range -7‘a very great deal worse’ to +7 – ‘a very great deal better’) at 12-weeks, dichotomised with scores of 3 defined as treatment success. Predictor variables were initially analysed with univariate analyses. Significant variables were than entered into a backward stepwise multivariate logistic regression.

Hylan G-F 20 Improves Hip Osteoarthritis: A Prospective, Randomized Study

We compared the efficacy and safety of intra-articular hylan G-F 20 with methylprednisolone acetate (MPA) for treating symptomatic Kellgren-Lawrence grade (KLG) 2 or 3 hip osteoarthritis in a prospective, randomized, multicenter, double-blind trial (N = 313). Two injections of hylan G-F 20 were administered 2 weeks apart (n = 150), or 1 injection of 40 mg MPA and 1 sham injection 2 weeks later (n = 155). The Western Ontario and McMaster Universities Arthritis Index (WOMAC) (total and subscale), clinician observations, and patient global assessments were collected at baseline and at weeks 4, 8, 12, 16, 20, and 26 (intent-to-treat population was analyzed; n = 305). Responder rates were assessed by WOMAC domain A, and criteria were established by the Outcome Measures in Rheumatology Clinical Trials–Osteoarthritis Research Society International (OMERACT-OARSI). At week 26, WOMAC A improved by 16.6 mm for hylan G-F 20 versus 13.6 mm for MPA. Response rates were higher with hylan G-F 20 versus MPA in patients with more advanced disease (KLG 3) and were similar between hylan G-F 20 and MPA in patients with less advanced disease (KLG 2). Adverse events were similar between groups and between patients with KLG 2 or 3. Hylan G-F 20 provided clinically meaningful improvements in pain and function, comparable with those of MPA, with good safety and tolerability. Thus, we conclude it is an appropriate option for treating hip osteoarthritis.

A Second Course of Hylan G-F 20 for the Treatment of Osteoarthritic Knee Pain – 12-Month Patient Follow-up

This prospective open-label study evaluated the efficacy and tolerability of a second course of hylan G-F 20 for the treatment of osteoarthritic knee pain over a 12-month period in patients who previously experienced a beneficial initial course of therapy. Men or women aged > or = 40 years with knee osteoarthritis received 3 weekly injections of hylan G-F 20. Consecutive patients requesting a second course of therapy were enrolled from October 2000 to January 2001. The mean time between the first and second courses of hylan G-F 20 was 19.6 months. All efficacy parameters significantly improved (P<.001) from baseline at weeks 1, 2, 4, 8, 12, 26, and 52. Improvements from baseline to weeks 26 and 52 for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) index question A1, WOMAC domain C, and total WOMAC were 1.39+/-0.11 and 1.1+/-0.12, 18.50+/-1.43 and 13.69+/-1.54, and 26.77+/-1.97 and 19.8+/-2.13, respectively. Significant improvements from baseline were maintained for patient and physician VAS to week 26 (patient: 48.66+/-2.52; investigator: 51.51+/-2.34) and week 52 (patient: 46.10+/-2.73; investigator: 47.23+/-2.52). A second course of hylan G-F 20 therapy was generally well-tolerated; the types of local events observed in this study were not qualitatively different from those in the current product information and published literature. For continued relief of osteoarthritic knee pain, this study supports repeat use of hylan G-F 20 in patients who had a previous successful course of therapy.