Intra-articular Injection Of Hylan Research Articles

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.

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.

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.

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.

Viscosupplementation with hylan G-F 20 (Synvisc): pain and mobility observations from 74 consecutive patients.

Seventy-four patients (120 knees, 360 injections) referred to an orthopedic surgery clinic by their primary care physician for osteoarthritis knee pain received 3 weekly intra-articular injections of hylan G-F 20 (Synvisc; Genzyme Biosurgery, Ridgefield, NJ). Osteoarthritic knee pain, the ability to perform activities, and the amount of pain medication, physiotherapy, and assistive device use were prospectively evaluated 1 month and 1 year after treatment. The majority of patients reported improved or much improved pain at 1 month (99%) and 1 year (91%) after hylan G-F 20 therapy. Patient activity was similarly improved in the majority of patients at 1 month (99%) and 1 year (69%) following physiotherapy. Of the 120 knees treated with hylan G-F 20, pain relief >6 months was reported for 62% of knees. Use of analgesics, nonsteroidal anti-inflammatory drugs, intra-articular steroids, physiotherapy, and assistive devices was reduced with hylan G-F 20 for 75%-100% of patients at 1 month, and was sustained at 1 year in the majority of patients (78%-94%) for the use of analgesics, steroids, and physiotherapy. Three (4%) patients experienced erythema and irritation at the injection site that resolved within 48 hours and did not interfere with the remaining injections. Hylan G-F 20 effectively and safely relieves osteoarthritis knee pain, facilitates an improved activity level, and decreases the need for pain medication, physiotherapy, and assistive devices.

Hylan G-F 20 Single-Injection Formulation

Hylan G-F 20, a cross-linked hyaluronic acid derivative, is an elastoviscous, high-molecular-weight (average 6000 kDa) fluid with rheological properties similar to those of knee synovial fluid of healthy young individuals. In a 26-week, randomized, double-blind, multicentre study in patients with symptomatic primary osteoarthritis of the knee (n = 253), one intra-articular injection of hylan G-F 20 (single-injection formulation) into the target knee significantly relieved pain (as measured by the Western Ontario and McMaster Universities Osteoarthritis Index pain [WOMAC A] subscale), including pain while walking on a flat surface (as assessed by the WOMAC A1 subscore), compared with placebo. Observer-reported disease status and patient-reported health status were also significantly improved in hylan G-F 20-treated patients compared with placebo-treated patients. A single intra-articular injection of hylan G-F 20 was generally well tolerated, with an adverse event profile similar to that of placebo. Repeat administration of hylan G-F 20 after 6 months had a similar tolerability profile to that of the initial injection. However, no patient who developed a target-knee adverse event after their first injection experienced such an event following their second injection.

Prospective Pilot Study of Painful Lumbar Facet Joint Arthropathy after Intra-articular Injection of Hylan G-F 20

To examine changes in pain, disability, and medication usage over time from baseline to up to 12 months after facet joint injection of hylan G-F 20. Prospective, uncontrolled, pilot study. University spine center. Fifteen patients (12 females), mean age of 57 years (standard deviation = 12.5), with a median duration of low back pain of 24 months (interquartile range = 11-66). Patients who fulfilled inclusion criteria underwent diagnostic blocks with local comparative anesthetics at one unilateral facet joint (FJ). Those with a true positive response underwent 2 1.0-mL intra-articular hylan G-F 20 injections, 10 days apart, into the painful FJ. A third hylan G-F 20 injection was offered to patients dissatisfied with the results obtained with the first 2 injections. Visual analog scale (VAS) (average, standing, walking), Oswestry Disability Index (ODI), SF-36, finger to floor distance (FTF), tolerance (standing, sitting, walking), analgesic usage, and patient satisfaction collected at baseline, 7-10 days, and at 1-, 3-, 6-, and 12-months follow-up. Repeated measures mixed-models indicated that VAS (average, standing, walking [P all < .005]), ODI (P = .029), SF-36 (P = .013), FTF (P = .032), and sitting tolerance (P = .020) all showed significant changes from baseline up to 6 months and were not sustained at 12 months; with the exception of the baseline to 12-month difference for FTF. There was not evidence of changes over time in standing (P = .085) or walking (P = .084) tolerance. Satisfaction initially increased from baseline (0%) to 7-10 days (64%) but declined over time (36% at 12 months). As compared with baseline (80%), analgesic usage decreased nominally over time showing significant decreases at 6 months (33%, P = .0253) and increased slightly at 12 months (45%). Viscosupplementation for lumbar FJ arthropathy with hylan G-F 20 is associated with modest efficacy that predominately lasts up to 6 months. Limitations include a small sample size and lack of both a control and blinding. Larger, randomized, controlled studies are indicated to better clarify its clinical safety, efficacy, and utility.

Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial

Objectives:The primary objective was to compare a single, 6 ml, intra-articular injection of hylan G-F 20 with placebo in patients with symptomatic knee osteoarthritis. The safety of a repeat injection...

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.

Are intra-articular injections of hylan more effective than injections of hyaluronic acid for knee osteoarthritis?

Are intra-articular injections of hylan more effective than injections of hyaluronic acid for knee osteoarthritis?

A prospective multi-centre, open study of the safety and efficacy of hylan G-F 20 (Synvisc®) in patients with symptomatic ankle (talo-crural) osteoarthritis

To evaluate the safety and efficacy of hylan G-F 20 in patients with ankle osteoarthritis. A prospective, open study in patients with symptomatic (>or=50 mm and <or=90 mm on a 100 mm VAS) ankle osteoarthritis. Patients received 1 ml x 2 ml intra-articular injection of hylan G-F 20, plus an optional, second injection if pain remained at baseline levels after 1, 2 or 3 months. The primary efficacy endpoint was the change from baseline in the pain VAS score at 3 months. Fifty-five patients received the first injection; 24 patients received a second. There were no serious or severe adverse events (AEs) related to the treatment. Seventeen patients experienced mild or moderate local, treatment-related AEs. The mean pain VAS score decreased from 68.0 mm (baseline) to 33.8 mm at 3 months (p<0.001), which was maintained to 6 months (34.2 mm, p<0.001). Hylan G-F 20 is well-tolerated and effective for up to 6 months in the treatment of symptomatic ankle osteoarthritis.

(626): Hylan G-F 20 attentuates knee pain in rat model of osteoarthritis

Osteoarthritis (OA) is joint disease characterized by progressive degeneration of articular cartilage and development of chronic pain. Although a clinical benefit of hyaluronic acid (HA) has been demonstrated in patients, the mechanisms underlying this therapeutic benefit remain elusive. Therefore, the objective of this study was to measure pain behaviors in a rat model of surgically-induced OA and utilize the model to evaluate the analgesic efficacy of hylan G-F 20 (cross-linked HA) for its ability provide pain relief. Previous studies in our laboratory have demonstrated histological evidence of OA lesions following menisectomy (MSX). Analysis of mechanical allodynia revealed significant increases in sensitivity that began within 72 hours post-surgery and persisted over the entire course of the experimental period. Morphine was able to reverse allodynia at each time point providing evidence that this behavior was pain related. Two weeks following OA induction the animals were treated by intra-articular injection of hylan G-F 20 (once a week for 3 weeks) or steroid (once) and tactile allodynia measured on day 3, 10, 15, 22, 29, 36, 43 and 50. Both IA treatment reversed allodynia on days 22, 29, 36, 43 and 50 following treatment. The study demonstrates ability of Hylan G-F 20 to provide pain relief comparable to that seen with steroid. OA pain is a complex process involving both peripheral and central sensitization. HA has been used to treat OA pain but its mechanism of action remains elusive. This is partly due to lack of animal models to evaluate pain in osteoarthritis. We have reproduced and employed rat models of OA pain to evaluate analgesic properties of HA. This result suggests that this model could provide us with a tool to understand how HA influences the molecules involved in induction and maintenance of chronic arthritic pain and evaluating drugs for relieving OA pain. Osteoarthritis (OA) is joint disease characterized by progressive degeneration of articular cartilage and development of chronic pain. Although a clinical benefit of hyaluronic acid (HA) has been demonstrated in patients, the mechanisms underlying this therapeutic benefit remain elusive. Therefore, the objective of this study was to measure pain behaviors in a rat model of surgically-induced OA and utilize the model to evaluate the analgesic efficacy of hylan G-F 20 (cross-linked HA) for its ability provide pain relief. Previous studies in our laboratory have demonstrated histological evidence of OA lesions following menisectomy (MSX). Analysis of mechanical allodynia revealed significant increases in sensitivity that began within 72 hours post-surgery and persisted over the entire course of the experimental period. Morphine was able to reverse allodynia at each time point providing evidence that this behavior was pain related. Two weeks following OA induction the animals were treated by intra-articular injection of hylan G-F 20 (once a week for 3 weeks) or steroid (once) and tactile allodynia measured on day 3, 10, 15, 22, 29, 36, 43 and 50. Both IA treatment reversed allodynia on days 22, 29, 36, 43 and 50 following treatment. The study demonstrates ability of Hylan G-F 20 to provide pain relief comparable to that seen with steroid. OA pain is a complex process involving both peripheral and central sensitization. HA has been used to treat OA pain but its mechanism of action remains elusive. This is partly due to lack of animal models to evaluate pain in osteoarthritis. We have reproduced and employed rat models of OA pain to evaluate analgesic properties of HA. This result suggests that this model could provide us with a tool to understand how HA influences the molecules involved in induction and maintenance of chronic arthritic pain and evaluating drugs for relieving OA pain.

Clinical response to intra-articular injections of hylan G-F 20 in symptomatic hip osteoarthritis: the OMERACT-OARSI criteria applied to the results of a pilot study

ObjectiveTo assess, using the OMERACT-OARSI criteria, the clinical response of patients presenting with symptomatic hip osteoarthritis (OA) to one intra-articular injection of hylan G-F 20. MethodsOpen-label, multi-centre, prospective, pilot study. Fifty-six patients presenting with primary hip OA, Kellgren–Lawrence grade II–III, age≥40, with walking pain measuring 50–90 mm on a 100 mm visual analogue scale (VAS). Intra-articular injection of a single 2 ml dose of hylan G-F 20 into the hip joint under fluoroscopic guidance. A second injection could be administered at day (D) 30, 60 or 90 if pain was unchanged or returned to baseline levels. Efficacy criteriaThe outcome of the first injection in the intent-to-treat (ITT) population was analysed 90 days after the injection in those patients that received a single injection, and on the day of the second injection in those patients that required two injections, using OMERACT-OARSI responder criteria (obtained from WOMAC A and C indices and the patient's global evaluation) and variation in walking pain on VAS. ResultsThe percentage of responders according to the OMERACT-OARSI response criteria was 53.6%. An inverse correlation was observed between reduction in pain and joint space narrowing score (P=0.03). ConclusionIn the absence of a control group, the efficacy of the treatment cannot be determined conclusively. Nevertheless these data suggest that hylan G-F 20 is a symptomatic treatment of hip OA, particularly in less severe radiological cases. A double-blind, controlled study is required to confirm these data.

Efficacy and safety of ultrasound guided intra-articular injections of hylan G-F 20 in patients with hip osteoarthritis

Abstract Aims: The aim of the study was to evaluate the efficacy of hylan G-F 20 (Synvisc) in the treatment osteoarthritis (OA) of the hip joint. Method: Twenty-seven patients (32 hips) with hip joint OA were enrolled in an open-label, prospective study. Demographics included 11 men and 16 women, 12 of whom had mild to moderate OA and 15 of whom had severe hip OA according to the Kellgren–Lawrence radiological grading system. Ultrasound-guided hyaluronic acid was administered to the affected hip from the lateral aspect of the joint at 1 week intervals, with a total of 3 treatments. The clinical assessment included visual analogue scale (VAS), Lequesne functional index, global patient assessment, Short-form 36 (SF-36), and use of paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs). All patients were evaluated at preinjection and at 2, 6, 12 weeks. Results: When compared with the preinjection values, there was a statistically significant reduction in the VAS and Lequesne index at 6 and 12 weeks. T...

Poster 79: Clinical experience of hylan G-F 20 efficacy in patients with knee osteoarthritis from a large, orthopedic practice

Objective: To evaluate the efficacy of hylan G-F 20 (Synvisc) for knee pain in osteoarthritis (OA). Design: Retrospective review of prospectively collected patient data. Setting: Large, knee-only, orthopedic clinical practice. Participants: Patients (N=1036; 1471 knees) who received hylan G-F 20 for osteoarthritic knee pain treatment from October 3, 1997 to April 30, 2002. Interventions: Intra-articular hylan G-F 20 (2mL; 3 weekly injections) using fluoroscopy for accurate needle placement. Main Outcome Measures: A physician visual analog scale (VAS; 100mm) was used to evaluate osteoarthritic knee pain at weeks 0, 1, 2, 4, 12, and 26. At weeks 4, 12, and 26, patients rated their pain and mobility on a 5-point scale (1=much worse, 5=much improved), and the amount of medication taken for osteoarthritic pain on a similar 5-point scale. Results: Approximately 72% of patients had radiologic OA grade IV. Physician VAS scores for pain associated with OA of the knee were significantly reduced with hylan G-F 20 at all timepoints compared with week 0 ( P<.0001). Mean VAS at week 0 was 77.5±13.8 compared with 23.4±23.7 at week 12 and 26.7±25.9 at week 26. Changes in VAS scores from week 0 indicated significant improvements in osteoarthritic knee pain at all timepoints ( P<.0001). At all timepoints subsequent to week 0, the majority of knees (62%–89%) had a positive response (≥20mm change in VAS from baseline). At weeks 4, 12, and 26, pain and mobility were improved or much improved in the majority of knees (60%–76%), and less or much less pain medication was taken for pain for the majority of knees (57%–68%) after hylan G-F 20 therapy. Conclusions: 3 intra-articular injections of hylan G-F 20 effectively relieved osteoarthritic knee pain and reduced pain medication needed for up to 6 months.

A 52-WEEK, OPEN-LABEL STUDY OF A SECOND COURSE OF HYLAN G-F 20 FOR THE TREATMENT OF OSTEOARTHRITIC KNEE PAIN

Hylan G-F 20 is approved to treat pain of osteoarthritis (OA) of the knee for up to 6 months. A second course of therapy may extend pain relief for longer periods. PURPOSE To evaluate the efficacy and safety of a second course of hylan G-F 20 for the treatment of OA knee pain for up to 52 weeks. METHODS Generally healthy men or women (n=70; age ≥ 40years) with knee OA received a second course of 3 intra-articular injections of hylan G-F 20 (2 mL) at 1-week intervals starting at baseline. Patients received a first course of therapy at least 3 months earlier. RESULTS Mean time between first and second courses was 19.6 months. All efficacy parameters (see table) were significantly lower than baseline with hylan G-F 20 at all timepoints measured (weeks 1, 2, 4, 8, 12, 26, and 52; p < 0.001). The table shows results for weeks 26 and 52. At baseline, the majority of patients had moderate to severe pain with no patients reporting mild or no pain, while most patients reported mild or no pain at weeks 26 and 52. The incidence of arthralgia (0.9%), arthrosis (4.6%), and arthritis (0.5%) in the target knee per injection was low. The types of related local adverse events seen with the second course of therapy were similar to those reported in the current prescribing materials.Table: Changes from Baseline at Weeks 26 and 52 for the Intent-to-Treat PopulationCONCLUSION A second course of hylan G-F 20 is generally well tolerated and may provide pain relief for up to 52 weeks after an initial successful course of therapy.

Coxarthrose : tolérance et effet à court terme de la viscosupplémentation par Hylane G-F20. Étude ouverte sur 22 patients

We studied the short-term safety and efficacy of intraarticular hylan G-F 20 (Synvisc®) in patients with symptomatic hip osteoarthritis. Methods. In this open-label prospective study, patients who had hip osteoarthritis with a visual analog pain scale score greater than 40/100 and a Lequesne index greater than 6 received one or two intraarticular injections of hylan G-F 20 under fluoroscopic guidance. The patients were evaluated once a month. A response was defined as a 50% decrease in the Lequesne score after one month as compared to baseline. Results. Thirty injections were performed in 22 patients with a mean age of 54 years. The response rate was 50% (11/22) after the first injection. Five of the 11 patients who failed to respond to the first injection received a second injection on day 30; two had a response, yielding a cumulative response rate of 13/22. In the six patients followed-up for more than six months, the improvement was sustained. Short-term safety was satisfactory, with a self-limited exacerbation of pain during the first few days in three patients but no infections or other side effects.

Hip osteoarthritis: short-term efficacy and safety of viscosupplementation by hylan G-F 20. An open-label study in 22 patients

We studied the short-term safety and efficacy of intraarticular hylan G-F 20 (Synvisc®) in patients with symptomatic hip osteoarthritis. Methods. In this open-label prospective study, patients who had hip osteoarthritis with a visual analog pain scale score greater than 40/100 and a Lequesne index greater than 6 received one or two intra-articular injections of hylan G-F 20 under fluoroscopic guidance. The patients were evaluated once a month. A response was defined as a 50% decrease in the Lequesne score after 1 month as compared to baseline. Results. Thirty injections were performed in 22 patients with a mean age of 54 years. The response rate was 50% (11/22) after the first injection. Five of the 11 patients who failed to respond to the first injection received a second injection on day 30; two had a response, yielding a cumulative response rate of 13/22. In the six patients followed up for more than 6 months, the improvement was sustained. Short-term safety was satisfactory, with a self-limited exacerbation of pain during the first few days in three patients but no infections or other side effects.

The role of viscosupplementation with hylan G-F 20 (Synvisc®) in the treatment of osteoarthritis of the knee: a Canadian multicenter trial comparing hylan G-F 20 alone, hylan G-F 20 with non-steroidal anti-inflammatory drugs (NSAIDs) and NSAIDs alone

To determine the safety and efficacy of viscosupplementation with hylan G-F 20, a cross-linked hyaluronan preparation, used either alone or in combination with continuous non-steroidal anti-inflammatory drug (NSAID) therapy, a randomized, controlled, multicenter clinical trial, assessed by a blinded assessor, was conducted in 102 patients with osteoarthritis (OA) of the knee. All patients were on continuous NSAID therapy for at least 30 days prior to entering the study. Patients were randomized into three parallel groups: (1) NSAID continuation plus three control arthrocenteses at weekly intervals; (2) NSAID discontinuation but with three weekly intra-articular injections of hylan G-F 20; and (3) NSAID continuation plus three injections, one every week, intra-articular injections of hylan G-F 20. Outcome measures of pain and joint function were evaluated by both the patients and an evaluator at baseline and weeks 1, 2, 3, 7 and 12, with a follow-up telephone evaluation at 26 weeks. At 12 weeks all groups showed statistically significant improvements from baseline, but did not differ from each other. A statistical test for the equivalence, the q-statistic, demonstrated that viscosupplementation with hylan G-F 20 was at least as good or better than continuous NSAID therapy for all outcome measurements except activity restriction. At 26 weeks both groups receiving hylan G-F 20 were significantly better than the group receiving NSAIDs alone. A transient local reaction was observed in three patients after hylan G-F 20 injection; only one patient withdrew from the study as a result and all recovered without any sequela. Hylan G-F 20 is a safe and effective treatment for OA of the knee and can be used either as a replacement for or an adjunct to NSAID therapy.